Document ID: FDA-2013-N-1393-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
Posted Date: 2019-08-21T04:00Z

[Federal Register Volume 84, Number 162 (Wednesday, August 21, 2019)]
[Notices]
[Pages 43606-43608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17999]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1393]

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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection provisions found in 
our Patent Term Restoration regulations.

DATES: Submit either electronic or written comments on the collection 
of information by October 21, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 21, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 21, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-1393 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Patent Term Restoration; Due 
Diligence Petitions; Filing, Format, and Content of Petitions.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly

[[Page 43607]]

available, you can provide this information on the cover sheet and not 
in the body of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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

    This information collection supports Agency regulations. FDA's 
patent extension activities are conducted under the authority of the 
Drug Price Competition and Patent Term Restoration Act of 1984 (21 
U.S.C. 355(j)) and the Generic 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 the FDA must undergo FDA safety, or safety and 
effectiveness review before marketing is permitted. If 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 the 
Drug Price Competition and Patent Term Restoration Act of 1984 and the 
Generic Animal Drug and Patent Term Restoration Act of 1988, 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 (USPTO) 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 USPTO based on a statutory formula. When a patent holder 
submits an application for patent term extension to USPTO, USPTO 
requests information from FDA, including the length of the regulatory 
review period for the patented product. If USPTO 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 (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 
petition 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.
    During the calendar years 2016 through 2018, 16 requests for 
revision of the regulatory review period were submitted under Sec.  
60.24(a). In addition, a total of three due diligence petitions were 
submitted under Sec.  60.30. There have been no requests for hearings 
under Sec.  60.40; however, for purposes of this information collection 
approval, we estimate that we may receive one submission annually.
    We estimate the burden of this collection of information as 
follows:

[[Page 43608]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                             Number of         Total          Average                         Average
        21 CFR part 60-- Patent Term Restoration             Number of    responses  per     responses      burden per      Total hours   annual  burden
                                                            respondents      respondent     (2016-2018)      response       (2016-2018)        hours
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60.24; revision of regulatory review period                           12           1.333              16             100           1,600          533.33
 determinations.........................................
60.30; due diligence petitions..........................               1               1               3              50             150              50
60.40; due diligence hearings...........................               1               1               1              10              10             3.3
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............          586.63
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects a 
small increase (+7 responses) associated with submissions received 
under Sec.  60.24 in previous years.

    Dated: August 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17999 Filed 8-20-19; 8:45 am]
 BILLING CODE 4164-01-P