Document ID: FDA-2010-N-0468-0001
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: 2010-10-05T04:00Z

[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Notices]               
[Page 61493-61494]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc10-107]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 December 6, 2010.

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: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
P150-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

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 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 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

[[Page 61494]]

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

                                  Table 1--Estimated Annual Reporting Burden\1\
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  21 CFR          No. of          Annual Frequency       Total Annual          Hours per
  Section       Respondents         per Response           Responses           Response           Total Hours
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60.24(a)                     1                   100                   1                 100                 100
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60.30                        1                    50                   1                  50                  50
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60.40                        1                   100                   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: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25010 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S