[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Notices]
[Page 28929-28930]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-59]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0204]
Agency Information Collection Activities; Proposed Collection;
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 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. Where a patented product must receive FDA approval before
marketing is permitted the Patent and Trademark Office (PTO) may add a
portion of FDA's review time to the term of a patent petitioners may
request reductions in the regulatory review time if FDA marketing
approval was not pursued with ``due diligence.''
DATES: Submit written or electronic comments on the collection of
information by July 19, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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 (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 drugs, animal drugs, 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
[[Page 28930]]
additive products. It did so by authorizing 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, that
agency 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
document in the Federal Register, 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 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, seven requests for revision of the regulatory review
period have been submitted under Sec. 60.24. Three 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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Annual Frequency per
21 CFR Part No. of Respondents Response Total Annual Responses Hours per Response Total Hours
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60.24(a) 7 1 7 100 700
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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 ..................... ..................... ....................... ..................... 800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 12, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11252 Filed 5-18-04; 8:45 am]
BILLING CODE 4160-01-S