[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68454-68455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1393]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on FDA's patent term restoration 
regulations on due diligence petitions for regulatory review period 
revision. Where a patented product must receive FDA approval before 
marketing is permitted, the Office of Patents and Trademarks may add a 
portion of the FDA review time to the term of a patent. Petitioners may 
request reductions in the regulatory review time if FDA marketing 
approval was not pursued with ``due diligence.''

DATES: Submit either electronic or written comments on the collection 
of information by January 13, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

[[Page 68455]]

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 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.
    FDA estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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: November 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27226 Filed 11-13-13; 8:45 am]
BILLING CODE 4160-01-P