[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)]
[Notices]
[Pages 41576-41577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20740]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0268]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 (the PRA).

DATES: Submit written comments on the collection of information by 
September 3, 1998.

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: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(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 
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 which 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

[[Page 41577]]

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

                                       Estimated Annual Reporting Burden1                                       
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                                                      Annual                                                    
         21 CFR Section               No. 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                                   0               0               0               0               0       
60.40                                   0               0               0               0               0       
Total                                                                                                 100       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


    Dated: July 29, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20740 Filed 8-3-98; 8:45 am]
BILLING CODE 4160-01-F