[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Notices]
[Pages 7678-7679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02753]


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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 March 
12, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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

    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 the FDA must undergo FDA safety, or safety and 
effectiveness, review before marketing is permitted. Where 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 (PTO) 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 PTO based on a statutory formula. When a patent holder 
submits an application for patent term extension to PTO, PTO requests 
information from FDA, including the length of the regulatory review 
period for the patented product. If PTO 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

[[Page 7679]]

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 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 
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.
    Since 1992, 15 requests for revision of the regulatory review 
period have been submitted under Sec.  60.24(a). For 2010, 2011, and 
2012, a total of three requests have been submitted under Sec.  
60.24(a). During that same time period, there have been no requests 
under Sec. Sec.  60.30 and 60.40; however, for purposes of this 
information collection approval, we are estimating that we may receive 
one submission annually.
    In the Federal Register of November 14, 2013 (78 FR 68454), 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 information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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60.24(a)........................               1               1               1             100             100
60.30...........................               1               1               1              50              50
60.40...........................               1               1               1              10              10
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    Total.......................                                                                             160
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02753 Filed 2-7-14; 8:45 am]
BILLING CODE 4160-01-P