```

[Federal Register Volume 66, Number 126 (Friday, June 29, 2001)]
[Notices]
[Pages 34684-34685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16323]

[[Page 34684]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0114]

Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Patent Term Restoration, Due Diligence 
Petitions, Filing, Format, and Content of Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by July 
30, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In compliance with section 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--Part 60 (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 
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 35 U.S.C. 156, 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, revision of 
the length of the regulatory review period, or may petition, under 
Sec. 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, 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, five requests for revision of the regulatory review 
period have been submitted under Sec. 60.24. One regulatory review 
period has been altered. No due diligence petitions have been submitted 
to FDA, under Sec. 60.30, and consequently there have been no requests 
for hearings, under Sec. 60.40, regarding the decisions on such 
petitions.
    In the Federal Register of March 23, 2001 (66 FR 16249), the agency 
requested comments on the proposed collection of information. There 
were no comments received.
    FDA estimates the burden of this collection of information as 
follows:

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

[[Page 34685]]

    Dated: June 25, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-16323 Filed 6-28-01; 8:45 am]
BILLING CODE 4160-01-S
```