[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Page 28929-28930]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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--

    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 

[[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 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                             Annual Frequency per
            21 CFR Part                No. of Respondents          Response         Total Annual Responses    Hours per Response        Total Hours
60.24(a)                                              7                      1                      7                      100                    700
60.30                                                 2                      0                      2                       50                    100
60.40                                                 0                      0                      0                        0                      0
Total                                .....................  .....................  .......................  .....................                 800
\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]