
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19063-19064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08325]


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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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[[Page 19064]]

SUMMARY: The Food and Drug Administration (FDA or we) 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 May 25, 
2017.

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 oira_submission@omb.eop.gov. 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.

Patent Term Restoration, Due Diligence Petitions, Filing, Format, and 
Content of Petitions--21 CFR Part 60--OMB Control Number 0910-0233--
Extension

SUPPLEMENTARY INFORMATION: 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. 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 (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 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 or 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.
    Since 1992, 20 requests for revision of the regulatory review 
period have been submitted under Sec.  60.24(a). In years 2013, 2014, 
and 2015, a total of five requests were 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 1, 2016 (81 FR 75824), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
notice.
    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 section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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60.24(a)........................               3            1.66               5             100             500
60.30...........................               1               1               1              50              50
60.40...........................               1               1               1              10              10
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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.


    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08325 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P


