[Federal Register Volume 91, Number 38 (Thursday, February 26, 2026)]
[Notices]
[Pages 9600-9601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-03900]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; Patent Term Extension and Adjustment
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice of information collection; request for comments.
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SUMMARY: The United States Patent and Trademark Office (hereafter
``USPTO'' or ``Agency'') will submit the following information
collection request to the Office of Management and Budget (OMB) for
review and clearance in accordance with the Paperwork Reduction Act of
1995, on or after the date of publication of this notice. The USPTO
invites comments on the information collection renewal of 0651-0020,
which helps the USPTO assess the impact of its information collection
requirements and minimize the reporting burden to the public. Public
comments were previously requested via the Federal Register on November
19, 2025, during a 60-day comment period (90 FR 52043). This notice
allows for an additional 30 days for public comments.
DATES: To ensure consideration, you must submit comments regarding this
information collection on or before March 30, 2026.
ADDRESSES: Written comments and recommendations for this information
collection should be submitted within 30 days of the publication of
this notice on the following website, http://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function and entering either the title of the information
collection or the OMB Control Number, 0651-0020. Do not submit
Confidential Business Information or otherwise sensitive or protected
information.
FOR FURTHER INFORMATION CONTACT:
This information collection request may be viewed at
http://www.reginfo.gov. Follow the instructions to view the Department
of Commerce, USPTO information collections currently under review by
OMB.
Email: [email protected]. Include ``0651-
0020 information request'' in the subject line of the message.
Mail: Justin Isaac, Office of the Chief Administrative
Officer, United States Patent and Trademark Office, P.O. Box 1450,
Alexandria, VA 22313-1450.
Telephone: Jeffrey West, Senior Legal Advisor, 571-272-
2226.
SUPPLEMENTARY INFORMATION:
Title: Patent Term Extension and Adjustment.
OMB Control Number: 0651-0020.
Abstract: The patent term restoration portion of the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417),
which is codified at 35 U.S.C. 156, permits the United States Patent
and Trademark Office (USPTO) to extend the term of protection under a
patent to compensate for delay during regulatory review and approval by
the Food and Drug Administration (FDA) or
[[Page 9601]]
United States Department of Agriculture (USDA). Only patents for drug
products, medical devices, food additives, or color additives are
potentially eligible for extension. The maximum length that a patent
may be extended under 35 U.S.C. 156 is five years. The USPTO
administers 35 U.S.C. 156 through 37 CFR 1.710-1.791.
This information collection covers information gathered in patent
term extension applications submitted under 35 U.S.C. 156(d). Under
this provision, an application for patent term extension must identify
the approved product; the patent to be extended; and the claims
included in the patent that cover the approved product, a method of
using the approved product, or a method of manufacturing the approved
product. 35 U.S.C. 156(d) also requires the submission of information
that enables the USPTO to determine the eligibility of the patent for
extension, and the rights that will be derived from the extension, and
information to enable the USPTO and the Secretary of Health and Human
Services or the Secretary of Agriculture to determine the period of the
extension. Additionally, 35 U.S.C. 156(d) requires the applicant for
patent term extension to provide a brief description of the activities
undertaken by the applicant during the regulatory review period with
respect to the approved product and the significant dates of these
activities.
This information collection also covers information gathered in
requests for interim extensions pursuant to 35 U.S.C. 156(d)(5) and
156(e)(2). Under 35 U.S.C. 156(d)(5), an interim extension may be
granted if the applicable regulatory review period that began for a
product is reasonably expected to extend beyond the expiration of the
patent term in effect. Under 35 U.S.C. 156(e)(2), an interim extension
may be granted if the term of an eligible patent for which an
application for patent term extension has been submitted would expire
before a certificate of extension is issued. In addition, this
information collection covers requests for review of final eligibility
decisions, and requests to withdraw an application requesting a patent
term extension after it is submitted.
Separate from the extension provisions of 35 U.S.C. 156, the USPTO
may in some cases adjust the term of an original patent under the
provisions of 35 U.S.C. 154 due to certain delays in the prosecution of
the patent application, including delays caused by interference and
derivation proceedings, secrecy orders, or appellate review by the
Patent Trial and Appeal Board or a federal court in which the patent is
issued pursuant to a decision reversing an adverse USPTO determination
of patentability. The USPTO administers 35 U.S.C. 154 through 37 CFR
1.701-1.705. The patent term provisions of 35 U.S.C. 154(b), as amended
by Title IV, Subtitle D of the Intellectual Property and Communications
Omnibus Reform Act of 1999, allow the applicant an opportunity to
request reconsideration of the USPTO's patent term adjustment
determination. This information collection covers information gathered
in such a request.
In addition, this information collection covers information
collected when the USPTO reduces the amount of a granted patent term
adjustment if delays were caused by an applicant's failure to make a
reasonable effort to respond to a communication from the USPTO within
three months of the communication's mailing date. Applicants may
petition for reinstatement of a reduction in patent term adjustment
with a showing that, in spite of all due care, the applicant was unable
to respond to a communication from the USPTO within the three-month
period.
Forms: None.
Type of Review: Extension and revision of a currently approved
information collection.
Affected Public: Private sector.
Respondent's Obligation: Required to obtain or retain benefits.
Frequency: On occasion.
Estimated Number of Annual Respondents: 903 respondents.
Estimated Number of Annual Responses: 903 responses.
Estimated Time per Response: The USPTO estimates that the responses
in this information collection will take the public approximately 1
hour to 25 hours to complete. This includes the time to gather the
necessary information, create the document, and submit the completed
item to the USPTO.
Estimated Total Annual Respondent Burden Hours: 6,807 hours.
Estimated Total Annual Respondent Non-hourly Cost Burden: $489,440.
The postage costs have increased since the publication of the 60-day
Federal Register notice, from $11.20 to $12.25 for the Priority Mail
legal flat rate envelope used for mailed submissions. As a result, the
estimated postage costs have increased from $101 to $110. This accounts
for the added $9 to the estimated total annual non-hourly cost burden.
Justin Isaac,
Information Collections Officer, Office of the Chief Administrative
Officer, United States Patent and Trademark Office.
[FR Doc. 2026-03900 Filed 2-25-26; 8:45 am]
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