[Federal Register: August 19, 2004 (Volume 69, Number 160)]
[Notices]
[Page 51468-51469]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au04-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0204]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
September 20, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: In compliance with 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 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 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 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
[[Page 51469]]
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.
In the Federal Register of May 19, 2004 (69 FR 28929), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual
21 CFR Section No. of Respondents Response Responses Hours per Response Total Hours
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60.24(a) 7 1 7 100 700
60.30 2 0 2 50 100
60.40 0 0 0 0 0
Total .................... .................... .................... .................... 800
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 12, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18976 Filed 8-18-04; 8:45 am]
BILLING CODE 4160-01-S