[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
60.24(a)                                1               1               1             100             100       
60.30                                   0               0               0               0               0       
60.40                                   0               0               0               0               0       
----------------------------------------------------------------------------------------------------------------
\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