Notice2022-17147
Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 10, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 153 (Wednesday, August 10, 2022)</title>
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[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48667-48669]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#beeeecffedcadfd8d8fed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="d080829183a4b1b6b690b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.
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
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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
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