Determination of Regulatory Review Period for Purposes of Patent Extension; AXONICS SACRAL NEUROMODULATION SYSTEM, 34757-34759 [2021-13972]
Download as PDF
<![CDATA[
34757
Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices
website at https://www.fda.gov/safety/
report-problem-fda for more
information. Since the inception of the
MedWatch program in July 1993, the
program has been promoting and
facilitating voluntary reporting by both
the public and healthcare professionals.
FDA has further encouraged voluntary
reporting by requiring inclusion of the
MedWatch toll-free phone number or
the MedWatch internet address on all
outpatient drug prescriptions dispensed,
as mandated by section 17 of the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109).
Section 906 of the FDA Amendments
Act amended section 502(n) of the
FD&C Act, mandating that published
direct-to-consumer advertisements for
prescription drugs include the following
statement printed in conspicuous text
(this includes vaccine products): ‘‘You
are encouraged to report negative side
effects of prescription drugs to the FDA.
Visit https://www.fda.gov/medwatch, or
call 1–800–FDA–1088.’’ Most private
vendors of consumer medication
information, the drug product-specific
instructions dispensed to consumers at
outpatient pharmacies, remind patients
to report ‘‘side effects’’ to FDA and
provide contact information to permit
MedWatch reporting.
mail or fax paper forms to the Agency
or electronically submit a report via the
MedWatch Online Voluntary Reporting
Form at https://
www.accessdata.fda.gov/scripts/
medwatch/. A fillable .pdf version of the
form, available at https://www.fda.gov/
downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM349464.pdf may be downloaded,
completed, and mailed or faxed to the
Agency. Reporting is supported for
drugs, non-vaccine biologicals, medical
devices, food products, special
nutritional products, cosmetics, and
non-prescription human drug products
marketed without an approved
application. The paper form may also be
used to submit reports about dietary
supplements. Electronic reports for
dietary supplements may be submitted
to the Agency via an online submission
route called the Safety Reporting Portal
at https://www.safetyreporting.hhs.gov/.
Electronic reports for tobacco products
may be submitted to the Agency via the
tobacco questionnaire within the online
Safety Reporting Portal at https://
www.safetyreporting.hhs.gov/.
We estimate the burden of this
collection of information as follows:
Since 2013, FDA has made available
the 3500B form. Proposed during the
previous authorization in 2012, the
3500B form is a version of the 3500 form
that is tailored for consumers and
written in plain language in
conformance with the Plain Writing Act
of 2010 (https://www.govinfo.gov/
content/pkg/PLAW-111publ274/pdf/
PLAW-111publ274.pdf). The 3500B
form evolved from several iterations of
draft versions, with input from human
factors experts, from other regulatory
agencies and with extensive input from
consumer advocacy groups and the
public. Since 2019, the 3500B form has
been available in Spanish at https://
www.fda.gov/safety/medwatch-fdasafety-information-and-adverse-eventreporting-program/reporting-seriousproblems-fda and available to upload
electronically since 2021 at https://
www.accessdata.fda.gov/scripts/
medwatch/
index.cfm?action=reporting.spanish.
Form FDA 3500B, may be used to
report adverse events, product
problems, product use errors and
problems after switching from one
product maker to another maker to the
Agency. The form is provided in both
paper and electronic formats.
Respondents may submit reports by
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA center or
21 CFR section
and/or FDA form
Average
burden per
response
Total annual
responses
Center for Biologics Evaluation and Research/Center for Drug Evaluation and
Research: Form 3500 ........................................................................................
14,727
1
14,727
Form 3500A(§§ 310.305, 314.80, 314.98, 600.80, and 1271.350) ......................
Form 3500A (§ 310.305 outsourcing facilities) .....................................................
Center for Devices and Radiological Health: Form 3500 .....................................
599
50
5,233
98
2
1
58,702
100
5,233
Form 3500A (part 803) .........................................................................................
Center for Food Safety and Applied Nutrition: Form 3500 ...................................
2,277
1,793
296
1
673,992
1,793
Form 3500A ..........................................................................................................
Center for Tobacco Products: Form 3500 ............................................................
1,659
39
1
1
1,659
39
All Centers: Form 3500B ......................................................................................
13,750
1
13, 750
Written requests for temporary waiver under § 329.100(c)(2) ..............................
1
1
1
0.66 (40
minutes)
1.21
1.21
0.66 (40
minutes)
1.21
0.66 (40
minutes)
1.21
0.66 (40
minutes)
0.46 (28
minutes)
1
Total ...............................................................................................................
........................
........................
........................
........................
1 There
Total hours
9,720
71,029
121
3,454
815,530
1,183
2,007
26
6,325
1
909,396
are no capital costs or operating and maintenance costs associated with this collection of information.
We are retaining the currently
approved burden estimates for the
information collection.
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13943 Filed 6–29–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2020–E–1340]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; AXONICS SACRAL
NEUROMODULATION SYSTEM
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
VerDate Sep<11>2014
17:47 Jun 29, 2021
Jkt 253001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for AXONICS SACRAL
NEUROMODULATION SYSTEM 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
SUMMARY:
E:\FR\FM\30JNN1.SGM
30JNN1
34758
Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices
of Commerce, for the extension of a
patent which claims that medical
device.
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 August 30, 2021.
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
December 27, 2021. 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. Electronic comments must
be submitted on or before August 30,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 30, 2021.
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.
DATES:
jbell on DSKJLSW7X2PROD with NOTICES
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:
VerDate Sep<11>2014
17:47 Jun 29, 2021
Jkt 253001
• 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–1340 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; AXONICS SACRAL
NEUROMODULATION SYSTEM.’’
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 § 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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 FDA
grants permission to market the device.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, 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 AXONICS SACRAL
NEUROMODULATION SYSTEM.
AXONICS SACRAL
NEUROMODULATION SYSTEM is
indicated for treatment of chronic fecal
incontinence in patients who have
failed or are not candidates for more
conservative treatments. Subsequent to
this approval, the USPTO received a
patent term restoration application for
AXONICS SACRAL
NEUROMODULATION SYSTEM (U.S.
Patent No. 7,331,499) from Alfred E.
Mann Foundation for Scientific
E:\FR\FM\30JNN1.SGM
30JNN1
Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
Research, and the USPTO requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated July 14,
2020, FDA advised the USPTO that this
medical device had undergone a
regulatory review period and that the
approval of AXONICS SACRAL
NEUROMODULATION SYSTEM
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
AXONICS SACRAL
NEUROMODULATION SYSTEM is 681
days. Of this time, 494 days occurred
during the testing phase of the
regulatory review period, while 187
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: October 27, 2017. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) for human tests to
begin, as required under section 520(g)
of the FD&C Act, became effective
October 27, 2017.
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): March 4, 2019.
The applicant claims March 1, 2019, as
the date the premarket approval
application (PMA) for AXONICS
SACRAL NEUROMODULATION
SYSTEM (PMA 190006) was initially
submitted. However, FDA records
indicate that PMA 190006 was
submitted on March 4, 2019.
3. The date the application was
approved: September 6, 2019. FDA has
verified the applicant’s claim that PMA
190006 was approved on September 6,
2019.
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 434 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
VerDate Sep<11>2014
17:47 Jun 29, 2021
Jkt 253001
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.
Dated: June 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13972 Filed 6–29–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0515]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Adverse Experience Reporting and
Recordkeeping for Drug and Biological
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 postmarketing
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
34759
reporting and recordkeeping of adverse
experiences for drug and biological
products.
DATES: Submit either electronic or
written comments on the collection of
information by August 30, 2021.
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 August 30,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 30, 2021.
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.’’
E:\FR\FM\30JNN1.SGM
30JNN1
]]>Agencies
[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34757-34759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13972]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-E-1340]
Determination of Regulatory Review Period for Purposes of Patent
Extension; AXONICS SACRAL NEUROMODULATION SYSTEM
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for AXONICS SACRAL
NEUROMODULATION SYSTEM 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
[[Page 34758]]
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 August 30, 2021.
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 December 27, 2021. 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. Electronic comments
must be submitted on or before August 30, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 30, 2021. 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-2020-E-1340 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; AXONICS SACRAL NEUROMODULATION SYSTEM.''
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
FDA grants permission to market the device. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (for example, 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 AXONICS SACRAL
NEUROMODULATION SYSTEM. AXONICS SACRAL NEUROMODULATION SYSTEM is
indicated for treatment of chronic fecal incontinence in patients who
have failed or are not candidates for more conservative treatments.
Subsequent to this approval, the USPTO received a patent term
restoration application for AXONICS SACRAL NEUROMODULATION SYSTEM (U.S.
Patent No. 7,331,499) from Alfred E. Mann Foundation for Scientific
[[Page 34759]]
Research, and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
July 14, 2020, FDA advised the USPTO that this medical device had
undergone a regulatory review period and that the approval of AXONICS
SACRAL NEUROMODULATION SYSTEM 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
AXONICS SACRAL NEUROMODULATION SYSTEM is 681 days. Of this time, 494
days occurred during the testing phase of the regulatory review period,
while 187 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: October 27, 2017. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) for human tests to begin, as required under section 520(g) of the
FD&C Act, became effective October 27, 2017.
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): March 4,
2019. The applicant claims March 1, 2019, as the date the premarket
approval application (PMA) for AXONICS SACRAL NEUROMODULATION SYSTEM
(PMA 190006) was initially submitted. However, FDA records indicate
that PMA 190006 was submitted on March 4, 2019.
3. The date the application was approved: September 6, 2019. FDA
has verified the applicant's claim that PMA 190006 was approved on
September 6, 2019.
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 434 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: June 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13972 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P
