Determination of Regulatory Review Period for Purposes of Patent Extension; BULKAMID URETHRAL BULKING SYSTEM, 56062-56064 [2022-19723]
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Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
FDA
approved VIOXX (rofecoxib) Tablets
(NDA 21042 and NDA 21647) and
VIOXX (rofecoxib) Suspension (NDA
21052) for the following indications:
• For relief of the signs and
symptoms of osteoarthritis.
• For relief of the signs and
symptoms of rheumatoid arthritis in
adults.
• For relief of the signs and
symptoms of pauciarticular or
polyarticular course juvenile
rheumatoid arthritis in patients 2 years
and older and who weigh 10 kg (22 lbs)
or more.
• For the management of acute pain
in adults.
• For the treatment of primary
dysmenorrhea.
• For the acute treatment of migraine
attacks with or without aura in adults.
On September 27, 2004, Merck
informed the Agency it had halted the
Adenomatous Polyp Prevention on
VIOXX (APPROVe) trial due to an
increased relative risk for confirmed
cardiovascular events, such as heart
attack and stroke, beginning after 18
months of treatment in patients taking
VIOXX (rofecoxib) compared to those
taking placebo. On September 30, 2004,
Merck voluntarily withdrew VIOXX
from the U.S. market. In early 2005,
FDA conducted a comprehensive review
of the approved cyclooxygenase-2
(COX–2) selective and non-selective
non-steroidal anti-inflammatory drugs
(NSAIDs) and the risk of adverse
cardiovascular events. On April 6, 2005,
after holding a joint meeting of the
Arthritis and Drug Safety and Risk
Management Advisory Committees,
FDA issued a decisional memorandum
summarizing the Agency’s analysis and
recommendations regarding the NSAIDs
that were the subject of the review
(https://www.fda.gov/media/74279/
download). In that report, FDA made
various recommendations, including
modifications to the safety information
in the labeling of approved COX–2
selective NSAIDs, including VIOXX. On
June 3, 2005, Merck subsequently
requested FDA’s input on the content of
potential supplemental NDAs to support
labeling changes, in the event that
Merck decided to bring the drug back to
the U.S. market. On December 12, 2005,
FDA identified certain safety analyses
and other information that would be
required in support of such
supplemental NDAs.
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SUPPLEMENTARY INFORMATION:
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In Merck’s letter requesting
withdrawal of VIOXX, Merck
summarized its views of the reasons for
withdrawal of approval as follows.
Merck ultimately made a business
decision not to recommence distribution
of VIOXX in the United States and,
therefore, did not conduct the
additional analyses or submit
supplemental NDAs supporting the
reintroduction of VIOXX. In light of the
company’s commercial decision not to
reintroduce VIOXX to the U.S. market,
Merck has requested that FDA withdraw
approval of NDA 21042, NDA 21052,
and NDA 21647 for VIOXX tablets and
suspension.
FDA has determined that withdrawal
of these NDAs under § 314.150(d) (21
CFR 314.150(d)) is appropriate, because
Merck did not provide the additional
information necessary to reintroduce
VIOXX (rofecoxib) to the U.S. market
that FDA requested in its December 12,
2005, correspondence. On October 7,
2021, Merck requested that FDA
withdraw approval of NDA 21042, NDA
21052, and NDA 21647 for VIOXX
(rofecoxib) under § 314.150(d) and
waived its opportunity for a hearing.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDA 21042 and
NDA 21647 for VIOXX (rofecoxib)
Tablets, 12.5 mg, 25 mg, and 50 mg, and
NDA 21052 for VIOXX (rofecoxib)
Suspension, 12.5 mg/5 mL and 25 mg/
5 mL, and all amendments and
supplements thereto, are withdrawn
under § 314.150(d). Distribution of
VIOXX (rofecoxib) Tablets, 12.5 mg, 25
mg, and 50 mg, and VIOXX (rofecoxib)
Suspension, 12.5 mg/5 mL and 25 mg/
5 mL, into interstate commerce without
an approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)).
Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19740 Filed 9–12–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–2255; FDA–
2020–E–2256; and FDA–2020–E–2254]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BULKAMID URETHRAL
BULKING SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BULKAMID URETHRAL BULKING
SYSTEM and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications 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 November 14, 2022.
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
March 13, 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
November 14, 2022. 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.
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
E:\FR\FM\13SEN1.SGM
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Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
jspears on DSK121TN23PROD with NOTICES
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 Nos. FDA–
2020–E–2255; FDA–2020–E–2256; and
FDA–2020–E–2254 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
BULKAMID URETHRAL BULKING
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
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17:30 Sep 12, 2022
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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 numbers, 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
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56063
(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 BULKAMID URETHRAL
BULKING SYSTEM. The BULKAMID
URETHRAL BULKING SYSTEM is
indicated for urethral injection for the
treatment of stress urinary incontinence
(SUI) due to intrinsic sphincter
deficiency in adult women who have
SUI or stress predominant mixed
incontinence. Subsequent to this
approval, the USPTO received patent
term restoration applications for
BULKAMID URETHRAL BULKING
SYSTEM (U.S. Patent Nos. 7,678,146;
7,758,497; and 7,780,958) from Contura
A/S, and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated March 1, 2021, FDA
advised the USPTO that this medical
device had undergone a regulatory
review period and that the approval of
the BULKAMID URETHRAL BULKING
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
the BULKAMID URETHRAL BULKING
SYSTEM is 4,529 days. Of this time,
3,617 days occurred during the testing
phase of the regulatory review period,
while 912 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: September 6, 2007. The
applicant claims that the investigational
device exemption (IDE) required under
section 520(g) of the FD&C Act for
human tests to begin became effective
on January 18, 2008. However, FDA
records indicate that the IDE was
determined substantially complete for
clinical studies to have begun on
September 6, 2007, which represents the
IDE effective date.
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): July 31, 2017. FDA
has verified the applicant’s claim that
the premarket approval application
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Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
(PMA) for BULKAMID URETHRAL
BULKING SYSTEM (PMA P170023) was
initially submitted July 31, 2017.
3. The date the application was
approved: January 28, 2020. FDA has
verified the applicant’s claim that PMA
P170023 was approved on January 28,
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 applications for patent extension,
this applicant seeks 5 years 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 § 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: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19723 Filed 9–12–22; 8:45 am]
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17:30 Sep 12, 2022
Food and Drug Administration
[Docket No. FDA–2022–D–1908]
Policy for Monkeypox Tests To
Address the Public Health Emergency;
Guidance for Laboratories,
Commercial Manufacturers, and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Policy for
Monkeypox Tests To Address the Public
Health Emergency.’’ On August 4, 2022,
the Secretary of the Department of
Health and Human Services (HHS)
determined that there is a public health
emergency related to monkeypox.
Monkeypox virus is a zoonotic infection
(a virus transmitted to humans from
animals), caused by Orthopoxvirus
genus of the Poxviridae family similar to
variola virus (the causative agent of
smallpox), and can spread to humans.
Since early May 2022, cases of
monkeypox have been reported from
countries where the disease is not
endemic and continue to be reported in
several endemic countries. Rapid
detection of monkeypox cases in the
United States requires wide availability
of diagnostic testing to control the
emergence of this contagious infection.
This guidance describes FDA’s review
priorities of emergency use
authorization (EUA) requests for
monkeypox diagnostic tests, as well as
FDA’s enforcement policies for various
monkeypox tests. The guidance
document has been implemented
without prior comment, but it remains
subject to comment in accordance with
the Agency’s good guidance practices.
DATES: The announcement of the
guidance is published in the Federal
Register on September 13, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
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HUMAN SERVICES
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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–
2022–D–1908 for ‘‘Policy for
Monkeypox Tests To Address the Public
Health Emergency.’’ Received comments
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
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]]>Agencies
[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56062-56064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19723]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-E-2255; FDA-2020-E-2256; and FDA-2020-E-2254]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BULKAMID URETHRAL BULKING SYSTEM
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 BULKAMID URETHRAL BULKING
SYSTEM and is publishing this notice of that determination as required
by law. FDA has made the determination because of the submission of
applications 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 November 14, 2022.
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 March 13, 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 November 14, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered 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
[[Page 56063]]
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 Nos.
FDA-2020-E-2255; FDA-2020-E-2256; and FDA-2020-E-2254 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; BULKAMID URETHRAL BULKING 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 numbers, 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 BULKAMID URETHRAL
BULKING SYSTEM. The BULKAMID URETHRAL BULKING SYSTEM is indicated for
urethral injection for the treatment of stress urinary incontinence
(SUI) due to intrinsic sphincter deficiency in adult women who have SUI
or stress predominant mixed incontinence. Subsequent to this approval,
the USPTO received patent term restoration applications for BULKAMID
URETHRAL BULKING SYSTEM (U.S. Patent Nos. 7,678,146; 7,758,497; and
7,780,958) from Contura A/S, and the USPTO requested FDA's assistance
in determining the patents' eligibility for patent term restoration. In
a letter dated March 1, 2021, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of the BULKAMID URETHRAL BULKING 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
the BULKAMID URETHRAL BULKING SYSTEM is 4,529 days. Of this time, 3,617
days occurred during the testing phase of the regulatory review period,
while 912 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: September 6, 2007. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
January 18, 2008. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
September 6, 2007, which represents the IDE effective date.
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): July 31,
2017. FDA has verified the applicant's claim that the premarket
approval application
[[Page 56064]]
(PMA) for BULKAMID URETHRAL BULKING SYSTEM (PMA P170023) was initially
submitted July 31, 2017.
3. The date the application was approved: January 28, 2020. FDA has
verified the applicant's claim that PMA P170023 was approved on January
28, 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 applications for patent extension,
this applicant seeks 5 years 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: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19723 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P
