Notice2026-10190
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
May 21, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 98 (Thursday, May 21, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 98 (Thursday, May 21, 2026)]
[Notices]
[Pages 29969-29970]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10190]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0497]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 22, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0233. Also include the FDA docket
number found in brackets in the heading of this document.
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#114143504265707777517775703f7979623f767e67"><span class="__cf_email__" data-cfemail="8cdcdecddff8edeaeacceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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
[[Page 29970]]
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.
In the Federal Register of February 18, 2026 (91 FR 7497), FDA
published a 60-day notice requesting public comment on the proposed
collection of information with respect to the following 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. One multi-part comment was received.
The commenter affirms that this information collection is necessary
for the FDA to administer the Patent Term Extension provisions of the
Hatch-Waxman Act. The commenter asserts, however, that the information
collection's value is contingent on whether it produces clear,
reliable, and appropriately bounded information, and that the low
volume of petitions received may suggest that the process is
underutilized. The commenter notes that due diligence petitions and
requests to revise regulatory review period determinations are not
purely administrative exercises--they frequently require integration of
legal analysis, scientific and technical documentation, and detailed
factual timelines, meaning actual burden may vary significantly and may
exceed FDA's estimates in some cases. The commenter suggests that
greater clarity regarding the types of information expected and the way
it should be presented would improve both the efficiency and
effectiveness of the collection. The commenter's suggestions generally
imply that standardization and clear articulation of the due diligence
process would reduce the burden on respondents. The commenter also made
several comments about the background, purpose, and policy
considerations of due diligence petitions concerning FDA regulatory
review period determinations for patent term extensions pursuant to the
Hatch-Waxman Act.
After thoroughly considering the commenter's thoughts on the
information collections assessed burden, FDA will not currently adjust
its burden estimates for the present submission until it analyzes
additional burden information. The Agency will observe the program and
process between now and the next renewal cycle. If evidence
corroborates the commenter's observations, refinements to the
information collection may be made at that time. Additionally, the
commenter also made several comments about the background, purpose, and
policy considerations of due diligence petitions and noted that the
Agency should consider refining the definition of ``due diligence.'' We
believe ``due diligence'' is adequately defined. We will not address
the remaining comments here as they are outside the scope of this
notice.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 60--patent term Number of responses per Total annual Average burden Total hours
restoration respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Revision of regulatory review 4 1.25 5 100 500
period determinations; Sec.
60.24..........................
Due diligence petitions; Sec. 1 1 1 50 50
60.30..........................
Due diligence hearings; Sec. 1 1 1 10 10
60.40..........................
-------------------------------------------------------------------------------
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. 2026-10190 Filed 5-20-26; 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 May 21, 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.