[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Notices]
[Pages 19152-19153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06573]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1393]
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.
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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 May 1, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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. The title of this information
collection is ``Patent Term Restoration; Due Diligence Petitions;
Filing, Format, and Content of Petitions.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
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 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 exercised by, a person during a
regulatory review period.'' As provided in Sec. 60.30(c), a due
diligence petition
[[Page 19153]]
``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 request, under
Sec. 60.40 (21 CFR 60.40), 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 August 10, 2022 (87 FR 48667), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR part 60--patent term Number of responses per Total annual Average burden Total hours
restoration respondents respondent responses per response
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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..........................
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Total....................... .............. .............. .............. .............. 560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
overall decrease of 34 hours and 11 responses. Since publication of the
60-day notice, we have adjusted our burden estimate to reflect an
annualized figure (reducing responses associated with Sec. 60.24 by
one-third), which results in a decrease to the currently approved
burden. There is also a small adjustment decrease of one response
associated with submissions received for revision of the regulatory
review period determination under Sec. 60.24 since our last review.
Dated: March 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06573 Filed 3-29-23; 8:45 am]
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