[Federal Register Volume 72, Number 196 (Thursday, October 11, 2007)]
[Notices]
[Pages 57950-57951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20070]



[[Page 57950]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0240]


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 
November 13, 2007.

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: 202-395-6974, or e-mailed 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: Karen L. Nelson, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4816.

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 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 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, nine requests for revision of the regulatory review 
period have been submitted under Sec.  60.24. Four regulatory review 
periods have been altered. Two due diligence petitions have been 
submitted to FDA under Sec.  60.30. There have been no requests for 
hearings under Sec.  60.40 regarding the decisions on such petitions.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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60.24(a)                                                                9                     1                  9                100                900
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60.30                                                                   2                     0                  2                 50                100
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60.40                                                                   0                     0                  0                  0                  0
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Total                                                                                                                                              1,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 57951]]

    In the Federal Register of July 9, 2007 (72 FR 37242), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

    Dated: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20070 Filed 10-10-07; 8:45 am]
BILLING CODE 4160-01-S