Notice2026-03094
Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 18, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection relating to our Patent Term Restoration regulations.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 32 (Wednesday, February 18, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 32 (Wednesday, February 18, 2026)]
[Notices]
[Pages 7497-7499]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03094]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0497]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Patent Term Restoration; Due Diligence Petitions;
Filing, Format, and Content of Petitions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection relating to our
Patent Term Restoration regulations.
DATES: Either electronic or written comments on the collection of
information must be submitted by April 20, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 20, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
[[Page 7498]]
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-0497 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Patent Term Restoration; Due
Diligence Petitions; Filing, Format, and Content of Petitions.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Anne Taylor, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5683,
<a href="/cdn-cgi/l/email-protection#1d4d4f5c4e697c7b7b5d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="76262437250217101036101217581e1e0558111900">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Patent Term Restoration; Due Diligence Petitions; Filing, Format, and
Content of Petitions--21 CFR Part 60
OMB Control Number 0910-0233--Extension
This information collection supports Agency regulations. FDA's
patent extension activities are conducted under the authority of
section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term
Restoration Act of 1988 (Pub. L. 100-670) (21 U.S.C. 301, et seq.). The
regulations are codified in part 60 (21 CFR part 60), Patent Term
Restoration. New human drug, animal drug, human biological, medical
device, food additive, or color additive products regulated by FDA must
undergo FDA safety, or safety and effectiveness review before marketing
is permitted. If the product is covered by a patent, part of the
patent's term may be consumed during this review, which diminishes the
value of the patent.
In enacting section 505(j) of the FD&C Act and the Generic Animal
Drug and Patent Term Restoration Act of 1988, Congress sought to
encourage development of new, safer, and more effective medical and
food additive products. It did so by authorizing the U.S. Patent and
Trademark Office (USPTO) to extend the patent term by a portion of the
time during which FDA's safety and effectiveness review prevented
marketing of the product. The length of the patent term extension is
generally limited to a maximum of 5 years and is calculated by USPTO
based on a statutory formula. When a patent
[[Page 7499]]
holder submits an application for patent term extension to USPTO, USPTO
requests information from FDA, including the length of the regulatory
review period for the patented product. If USPTO concludes that the
product is eligible for patent term extension, FDA publishes a notice
that describes the length of the regulatory review period and the dates
used to calculate that period. Interested parties may request, under
Sec. 60.24 (21 CFR 60.24), revision of the length of the regulatory
review period, or may petition under Sec. 60.30 (21 CFR 60.30) to
reduce the regulatory review period by any time where marketing
approval was not pursued with ``due diligence.''
In 21 CFR 60.36(a) due diligence is defined as ``that degree of
attention, continuous directed effort, and timeliness as may reasonably
be expected from, and are ordinarily exercised by, a person during a
regulatory review period.'' As provided in Sec. 60.30(c), a due
diligence petition ``shall set forth sufficient facts, including dates,
if possible, to merit an investigation by FDA of whether the applicant
acted with due diligence.'' Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates whether any change in the
regulatory review period is necessary. If so, the corrected regulatory
review period is published in the Federal Register. A due diligence
petitioner not satisfied with FDA's decision regarding the petition
may, under Sec. 60.40 (21 CFR 60.40), request an informal hearing for
reconsideration of the due diligence determination. Petitioners are
likely to include persons or organizations having knowledge that FDA's
marketing permission for that product was not actively pursued
throughout the regulatory review period. The information collection for
which an extension of approval is being sought is the use of the
statutorily created due diligence petition.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of Total Average
21 CFR part 60--patent term restoration Number of responses per annual burden per Total
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Revision of regulatory review period 4 1.25 5 100 500
determinations; Sec. 60.24....................
Due diligence petitions; Sec. 60.30............ 1 1 1 50 50
Due diligence hearings; Sec. 60.40............. 1 1 1 10 10
--------------------------------------------------------------
Total........................................ ............ .............. .......... ........... 560
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimates on our experience and the average number of
requests for revision of regulatory review period determinations, due
diligence petitions, and requests for hearing received in the past 3
years. We estimate that 4 respondents will submit an average of 1.25
requests for revision of the regulatory review period determinations
annually, for a total of 5 requests received annually. We assume that
it will take respondents 100 hours to prepare the factual and legal
information necessary to submit a request for revision. Thus, we
estimate a total reporting burden of 500 hours. We estimate that one or
fewer due diligence petitions will be submitted annually and that will
take a respondent 50 hours to prepare the petition, for a total of 50
hours. We estimate that one or fewer requests for hearing will be
submitted annually and that it will take a respondent 10 hours to
prepare the request for hearing, for a total of 10 hours.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03094 Filed 2-17-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 18, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.