[Federal Register Volume 66, Number 57 (Friday, March 23, 2001)]
[Notices]
[Pages 16249-16251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0114]


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

[[Page 16250]]

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 Office of 
Patents and Trademarks may add a portion of the FDA 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 May 22, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 L. Nelson, Office of Information 
Resources Management (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: (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 No. 
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 
patents'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 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 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 that 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 Burden\1\
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                                        Annual Frequency     Total Annual
  21 CFR Section    No. of Respondents    per Response         Responses      Hours per Response    Total Hours
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60.24(a)                    1                  1                  1                 100               100
60.30                       0                  0                  0                   0                 0

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Total                                                                                                 100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 19, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-7243 Filed 3-22-01; 8:45 am]
BILLING CODE 4160-01-S