Document ID: FDA-2010-N-0468-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
Posted Date: 2011-01-12T05:00Z

[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2127-2128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-459]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0468]

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 11, 2011.

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 e-mailed 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.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

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--(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 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 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, 12 requests for revision of the regulatory review 
period have been submitted under Sec.  60.24. For 2007, 2008, and 2009, 
a total of three, or one per year, have been submitted under Sec.  
60.24. Two regulatory review periods have been altered. During that 
same time period, two due diligence petitions were submitted to FDA 
under Sec.  60.30, for an average of fewer than one per year. There 
have been no requests for hearings under Sec.  60.40 regarding the 
decisions on such petitions; however, for purposes of this information 
collection approval, we are estimating that we may receive one 
submission annually.
    In the Federal Register of October 5, 2010 (75 FR 61493), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 2128]]

                                  Table 1--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR section              Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        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: January 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-459 Filed 1-11-11; 8:45 am]
BILLING CODE 4160-01-P