Document ID: FDA-2013-N-1393-0012
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: 2022-08-10T04:00Z

[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48667-48669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17147]

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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: Either electronic or written comments on the collection of 
information must be submitted by October 11, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 11, 2022. 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

[[Page 48668]]

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, 240-402-7500.
     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 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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 
section 505(j) of the Federal, Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term 
Restoration Act of 1988 ((Pub. L. 100-670) (21 U.S.C. 301 et seq)). The 
regulations are codified in part 60 (21 CFR part 60), Patent Term 
Restoration. 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. 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 section 505(j) of the FD&C Act 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, 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.''
    Section 60.36(a) 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

[[Page 48669]]

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.
    During the calendar years 2019 through 2022, 15 requests for 
revision of the regulatory review period were submitted under Sec.  
60.24(a). In addition, a total of one due diligence petition was 
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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
   21 CFR part 60--patent term       Number of     responses per   Total annual   Average burden    Total hours
           restoration              respondents     respondent       responses     per response
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60.24; revision of regulatory                  4            3.75              15             100           1,500
 review period determinations...
60.30; due diligence petitions..               1               1               1              50              50
60.40; due diligence hearings...               1               1               1              10              10
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    Total.......................  ..............  ..............  ..............  ..............           1,560
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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 decrease (-1 response) associated with submissions received under 
Sec.  60.24 in previous years.

    Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17147 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P