Determination of Regulatory Review Period for Purposes of Patent Extension; CINTEC PLUS CYTOLOGY, 17579-17581 [2023-05908]
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Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
and work to improve their
implementation. Finally, REMS
generally must have a timetable for
submission of assessments of the
strategy.
FDA can require a REMS before initial
approval of a new drug application
(NDA) or biologics license application
(BLA) or after the drug has been
approved if FDA becomes aware of new
safety information about a drug and
determines that a REMS is necessary to
ensure that the benefits of the drug
outweigh its risks. Under section 505–
1(i)(1) of the FD&C Act, a drug that is
approved under an abbreviated new
drug application (ANDA) is only
required to have certain elements of a
REMS if these elements are required for
the applicable listed drug: a Medication
Guide or patient package insert, a
packaging or disposal requirement,
ETASU, and an implementation system.
When applicants develop REMS with
ETASU, particularly those ETASU that
require verification of certain conditions
before the drug is dispensed, they often
hire third-party vendors to design
operational components to help
implement and manage the program
requirements. These third-party
vendors, often referred to as REMS
administrators, may perform a variety of
functions for the REMS program,
including building and operating a
centralized database or repository for
patient enrollment, prescriber and
pharmacy certifications, and wholesaler
enrollments. They often host a website
or web portal that participants, such as
patients, prescribers, pharmacies, and
wholesalers, use to enroll in the
program, and they provide the
technological means for pharmacies and
other dispensers to perform the
necessary verifications at the point of
dispensing. These operational
components are often referred to
collectively as the ‘‘REMS system.’’ In
many cases, therefore, the REMS
administrator performs critical
functions in the daily operations of a
REMS which directly impact patient
access to the drug.
Applicants may submit modifications
to their REMS at any time after approval
which propose the addition,
modification, or removal of any goal or
element of the approved strategy. While
FDA does not approve REMS
administrators or changes in REMS
administrators per se, an applicant’s
decision to change a REMS
administrator may affect the REMS
system, prompting an applicant to
propose a REMS modification.
Implementing such a change has the
potential to cause significant
disruptions in the operations of the
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program, including the ability for
stakeholders to interact with the tools
necessary to fulfill the various REMS
requirements. These disruptions can
impact patients’ ability to access the
drug.
The Consolidated Appropriations Act,
2023, signed into law on December 29,
2022, specified that ‘‘[n]ot later than 90
days after the date of enactment of this
Act, the Secretary shall open a single
public docket to solicit comments on
factors that generally should be
considered by the Secretary when
reviewing requests from sponsors of
drugs subject to [REMS] to change thirdparty vendors engaged by sponsors to
aid in implementation and management
of the strategies. . . . Such factors
include the potential effects of changes
in third-party vendors on—(A) patient
access; and (B) prescribing and
administration of the drugs by
healthcare providers.’’
II. Request for Comments
FDA is soliciting comments from
stakeholders regarding the factors that
FDA should consider when it reviews a
proposed REMS modification that is
prompted by or related to a change in
a REMS administrator for a REMS with
ETASU. In addition to general factors,
such as effect of the modification on
patient access and prescribing and
administration by healthcare providers,
FDA is interested in comments on the
following topics:
1. Comment on any stakeholder input
that the applicant and/or REMS
administrator should obtain prior to
developing and implementing a new
REMS system, including the extent and
timing of stakeholder input.
2. Comment on whether the sponsor
and/or REMS administrator should
conduct testing of the changes to the
operation of the REMS system prior to
full implementation including:
• User acceptance testing with
stakeholders and evaluation of any
unexpected impact on stakeholder
workflow
• An assessment of REMS data flows,
including whether REMS data from the
existing REMS system can be timely and
successfully transferred to a new REMS
system.
3. Comment on the amount of time
needed to transition stakeholders from
one REMS system to another REMS
system (e.g., enrollment or
recertification), and the factors that go
into that time frame.
4. Comment on whether the sponsor
and/or the REMS administrator should
conduct a failure modes and effects
analysis to identify and plan for system
failures. This includes providing for
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17579
adequate support services in the event
that the system fails to work as intended
following full implementation of the
new REMS system.
5. Comment on the metrics that the
sponsor should capture to evaluate
whether the REMS system was
successfully and efficiently
implemented.
Dated: March 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05962 Filed 3–22–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–2097]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CINTEC PLUS CYTOLOGY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for CINTEC PLUS CYTOLOGY and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by May 22, 2023.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 19, 2023. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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
May 22, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
DATES:
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Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
timely if they are received on or before
that date.
ddrumheller on DSK120RN23PROD with NOTICES1
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–
2020–E–2097 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; CINTEC PLUS
CYTOLOGY.’’ 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
VerDate Sep<11>2014
19:23 Mar 22, 2023
Jkt 259001
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 § 10.20 (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-201509-18/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:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a medical device will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the
medical device CINTEC PLUS
CYTOLOGY. CINTEC PLUS
CYTOLOGY is a qualitative
immunocytochemical assay intended for
the simultaneous detection of the
p16INK4a and Ki-67 proteins in cervical
specimens collected by a clinician using
an endocervical brush/spatula or broom
collection device and placed in the
ThinPrep Pap Test PreservCyt Solution.
Subsequent to this approval, the USPTO
received a patent term restoration
application for CINTEC PLUS
CYTOLOGY (U.S. Patent No. 8,367,353)
from Ventana Medical Systems, Inc.,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated November 9, 2020, FDA
advised the USPTO that this medical
device had undergone a regulatory
review period and that the approval of
CINTEC PLUS CYTOLOGY represented
the first permitted commercial
marketing or use of the product.
Thereafter, the USPTO requested that
FDA determine the product’s regulatory
review period.
I. Background
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
CINTEC PLUS CYTOLOGY is 181 days.
Of this time, 0 days occurred during the
testing phase of the regulatory review
period, while 181 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: not applicable. The applicant
claims that the investigational device
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
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Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices
exemption (IDE) required under section
520(g) of the FD&C Act for human tests
to begin became effective on September
12, 2017. However, FDA records
indicate that there was no IDE
associated with the product, so the
claimed date is not applicable.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): September 12,
2019. The applicant claims September
11, 2019, as the date the premarket
approval application (PMA) for CINTEC
PLUS CYTOLOGY (PMA P190024) was
initially submitted. However, FDA
records indicate that PMA P190024 was
submitted on September 12, 2019.
3. The date the application was
approved: March 10, 2020. FDA has
verified the applicant’s claim that PMA
P190024 was approved on March 10,
2020.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 547 days of patent
term extension.
ddrumheller on DSK120RN23PROD with NOTICES1
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
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19:23 Mar 22, 2023
Jkt 259001
Dated: March 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05908 Filed 3–22–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–3014]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RECELL AUTOLOGOUS
CELL HARVESTING DEVICE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for RECELL AUTOLOGOUS CELL
HARVESTING DEVICE and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological device.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by May 22, 2023.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 19, 2023. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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
May 22, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
PO 00000
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17581
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–
2019–E–3014 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; RECELL
AUTOLOGOUS CELL HARVESTING
DEVICE.’’ 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
E:\FR\FM\23MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17579-17581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05908]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-E-2097]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CINTEC PLUS CYTOLOGY
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for CINTEC PLUS CYTOLOGY and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
medical device.
DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by May 22, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by September 19, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
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 May 22, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered
[[Page 17580]]
timely if they are received 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-2020-E-2097 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; CINTEC PLUS CYTOLOGY.'' 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 Sec. 10.20 (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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device CINTEC PLUS
CYTOLOGY. CINTEC PLUS CYTOLOGY is a qualitative immunocytochemical
assay intended for the simultaneous detection of the p16INK4a and Ki-67
proteins in cervical specimens collected by a clinician using an
endocervical brush/spatula or broom collection device and placed in the
ThinPrep Pap Test PreservCyt Solution. Subsequent to this approval, the
USPTO received a patent term restoration application for CINTEC PLUS
CYTOLOGY (U.S. Patent No. 8,367,353) from Ventana Medical Systems,
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
November 9, 2020, FDA advised the USPTO that this medical device had
undergone a regulatory review period and that the approval of CINTEC
PLUS CYTOLOGY represented the first permitted commercial marketing or
use of the product. Thereafter, the USPTO requested that FDA determine
the product's regulatory review period.
II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for
CINTEC PLUS CYTOLOGY is 181 days. Of this time, 0 days occurred during
the testing phase of the regulatory review period, while 181 days
occurred during the approval phase. These periods of time were derived
from the following dates:
1. The date an exemption for this device, under section 520(g) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)), became effective: not applicable. The applicant claims that
the investigational device
[[Page 17581]]
exemption (IDE) required under section 520(g) of the FD&C Act for human
tests to begin became effective on September 12, 2017. However, FDA
records indicate that there was no IDE associated with the product, so
the claimed date is not applicable.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e):
September 12, 2019. The applicant claims September 11, 2019, as the
date the premarket approval application (PMA) for CINTEC PLUS CYTOLOGY
(PMA P190024) was initially submitted. However, FDA records indicate
that PMA P190024 was submitted on September 12, 2019.
3. The date the application was approved: March 10, 2020. FDA has
verified the applicant's claim that PMA P190024 was approved on March
10, 2020.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 547 days of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: March 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05908 Filed 3-22-23; 8:45 am]
BILLING CODE 4164-01-P
