[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Notices]
[Pages 27090-27092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12897]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0268]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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.
DATES: Submit written comments on the collection of information by July
14, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-
[[Page 27091]]
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857. All comments should be identified with the docket
number found in brackets in the heading of this document.
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: 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 listed below.
With respect to the following collection of information, FDA
invites comments on: (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--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 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, 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--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
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 27092]]
Dated: May 7, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-12897 Filed 5-14-98; 8:45 am]
BILLING CODE 4160-01-F
