[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
