[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3934-3935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01084]


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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: Fax written comments on the collection of information by 
February 24, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0233. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 the 
Drug Price Competition and Patent Term Restoration Act of 1984 (21 
U.S.C. 355(j)) and the Generic Animal Drug and Patent Term Restoration 
Act of 1988 (35 U.S.C. 156). 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 the Drug Price Competition and Patent Term Restoration 
Act of 1984 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.''
    The statute (21 CFR 60.36) defines due diligence 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 petition 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.
    During the calendar years 2016 through 2018, 16 requests for 
revision of the regulatory review period were submitted under Sec.  
60.24(a). In addition, a total of three due diligence petitions were 
submitted under Sec.  60.30. There have been no requests for hearings 
under Sec.  60.40; however, for purposes of this information collection 
approval, we estimate that we may receive one submission annually.
    In the Federal Register of August 21, 2019 (84 FR 43606), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

[[Page 3935]]



                                                      Table 1--Estimated Annual Reporting Burden 1
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                                                                             Number of         Total          Average                         Average
         21 CFR part 60--Patent term restoration             Number of     responses per     responses      burden per      Total hours    annual burden
                                                            respondents     respondent      (2016-2018)      response       (2016-2018)        hours
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60.24; revision of regulatory review period                           12           1.333              16             100           1,600          533.33
 determinations.........................................
60.30; due diligence petitions..........................               1               1               3              50             150              50
60.40; due diligence hearings...........................               1               1               1              10              10             3.3
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............          586.63
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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 a 
small increase (+7 responses) associated with submissions received 
under Sec.  60.24 in previous years.

    Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01084 Filed 1-22-20; 8:45 am]
 BILLING CODE 4164-01-P