[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]
BILLING CODE 4164-01-P