Determination of Regulatory Review Period for Purposes of Patent Extension; Med-El Electric and Acoustic Stimulation Hybrid Hearing Prosthesis System, 50042-50044 [2019-20657]
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50042
Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 / Notices
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ATROPINE SULFATE ANSYR
PLASTIC SYRINGE (atropine sulfate
solution) intravenous, intramuscular,
subcutaneous, and endotracheal, 0.5
mg/5 mL (0.1 mg/mL), is the subject of
NDA 021146, held by Hospira, Inc., and
initially approved on July 9, 2001.
ATROPINE SULFATE ANSYR PLASTIC
SYRINGE (atropine sulfate solution)
intravenous, intramuscular,
subcutaneous, and endotracheal, 0.5
mg/5 mL (0.1 mg/mL), is indicated for
temporary blockade of severe or lifethreatening muscarinic effects (e.g., as
an antisialagogue, an antivagal agent, an
antidote for organophosphorus or
muscarinic mushroom poisoning, and to
treat bradyasystolic cardiac arrest).
ATROPINE SULFATE ANSYR
PLASTIC SYRINGE (atropine sulfate
solution) intravenous, intramuscular,
subcutaneous, and endotracheal, 0.5
mg/5 mL (0.1 mg/mL), has never been
marketed. In previous instances (see
e.g., 72 FR 9763 (March 5, 2007) and 61
FR 25497 (May 21, 1996)), the Agency
has determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
Lachman Consultants submitted a
citizen petition dated May 1, 2019
(Docket No. FDA–2019–P–2123), under
21 CFR 10.30, requesting that the
Agency determine whether ATROPINE
SULFATE ANSYR PLASTIC SYRINGE
(atropine sulfate solution) intravenous,
intramuscular, subcutaneous, and
endotracheal, 0.5 mg/5 mL (0.1 mg/mL),
was withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ATROPINE SULFATE
ANSYR PLASTIC SYRINGE (atropine
sulfate solution) intravenous,
intramuscular, subcutaneous, and
endotracheal, 0.5 mg/5 mL (0.1 mg/mL),
was not withdrawn for reasons of safety
or effectiveness. The petitioner has
identified no data or other information
suggesting that ATROPINE SULFATE
ANSYR PLASTIC SYRINGE (atropine
sulfate solution) intravenous,
intramuscular, subcutaneous, and
endotracheal, 0.5 mg/5 mL (0.1 mg/mL),
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
VerDate Sep<11>2014
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Jkt 247001
concerning the withdrawal of
ATROPINE SULFATE ANSYR PLASTIC
SYRINGE (atropine sulfate solution)
intravenous, intramuscular,
subcutaneous, and endotracheal, 0.5
mg/5 mL (0.1 mg/mL), from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ATROPINE SULFATE
ANSYR PLASTIC SYRINGE (atropine
sulfate solution) intravenous,
intramuscular, subcutaneous, and
endotracheal, 0.5 mg/5 mL (0.1 mg/mL),
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to ATROPINE SULFATE ANSYR
PLASTIC SYRINGE (atropine sulfate
solution) intravenous, intramuscular,
subcutaneous, and endotracheal, 0.5
mg/5 mL (0.1 mg/mL), may be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
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 the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by November 25, 2019.
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 23, 2020. 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 November 25,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 25, 2019.
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.
Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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
[FR Doc. 2019–20662 Filed 9–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–E–0267]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Med–El Electric and
Acoustic Stimulation Hybrid Hearing
Prosthesis 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 MED–EL Electric and Acoustic
Stimulation Hybrid Hearing Prosthesis
System (MED–EL EAS) and is
SUMMARY:
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Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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–
2018–E–0267 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; MED–EL Electric
and Acoustic Stimulation Hybrid
Hearing Prosthesis 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.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
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17:37 Sep 23, 2019
Jkt 247001
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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 MED–EL EAS. The
MED–EL EAS is intended to provide
electrical stimulation to the mid- to
high-frequency region of the cochlea
and acoustic amplification to the lowfrequency regions, for candidates with
residual low frequency hearing
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50043
sensitivity. The MED–EL EAS is
indicated for partially deaf individuals
aged 18 years and older who have
residual hearing sensitivity in the low
frequencies sloping to a severe/
profound sensorineural hearing loss in
the mid to high frequencies, and who
obtain minimal benefit from
conventional acoustic amplification.
Subsequent to this approval, the USPTO
received a patent term restoration
application for MED–EL EAS (U.S.
Patent No. 7,917,224) from Med-El
Electromedizinische Gerate GmbH, and
the USPTO requested FDA’s assistance
in determining this patent’s eligibility
for patent term restoration. In a letter
dated April 5, 2018, FDA advised the
USPTO that this medical device had
undergone a regulatory review period
and that the approval of MED–EL EAS
represented the first permitted
commercial marketing or use of this
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
MED–EL EAS is 4,537 days. Of this
time, 4,269 days occurred during the
testing phase of the regulatory review
period, while 268 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: April 16, 2004. 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 2,
2004. However, FDA records indicate
that the IDE was determined
substantially complete for clinical
studies to have begun on April 16, 2004,
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): December 23,
2015. FDA has verified the applicant’s
claim that the premarket approval
application (PMA) for MED–EL EAS
(PMA P000025 S084) was initially
submitted December 23, 2015.
3. The date the application was
approved: September 15, 2016. FDA has
verified the applicant’s claim that PMA
P000025 S084 was approved on
September 15, 2016.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
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Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 / Notices
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 998 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 § 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 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–20657 Filed 9–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4212]
Wholesale Distributor Verification
Requirement for Saleable Returned
Drug Product—Compliance Policy;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
khammond on DSKJM1Z7X2PROD with NOTICES
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Wholesale Distributor Verification
Requirement for Saleable Returned Drug
Product—Compliance Policy.’’ This
SUMMARY:
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17:37 Sep 23, 2019
Jkt 247001
guidance describes FDA’s intention
regarding enforcement of the Drug
Supply Chain Security Act (DSCSA)
provision requiring wholesale
distributors to verify a product identifier
prior to further distributing returned
product beginning on November 27,
2019. Given concerns expressed by
stakeholders and to minimize possible
disruptions in the pharmaceutical
distribution supply chain, FDA does not
intend to take action against wholesale
distributors who do not, prior to
November 27, 2020, verify a product
identifier prior to further distributing
returned product as required under the
DSCSA. This represents a 1-year delay
in enforcement of this DSCSA
requirement.
DATES: The announcement of the
guidance is published in the Federal
Register on September 24, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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–D–4212 for ‘‘Wholesale
Distributor Verification Requirement for
Saleable Returned Drug Product—
Compliance Policy.’’ 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.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
E:\FR\FM\24SEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50042-50044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-E-0267]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Med-El Electric and Acoustic Stimulation Hybrid Hearing
Prosthesis 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 MED-EL Electric and
Acoustic Stimulation Hybrid Hearing Prosthesis System (MED-EL EAS) 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
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
November 25, 2019. 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 23,
2020. 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 November 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 25, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the
[[Page 50043]]
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-2018-E-0267 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; MED-EL Electric and Acoustic Stimulation
Hybrid Hearing Prosthesis 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.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/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.
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 MED-EL EAS. The
MED-EL EAS is intended to provide electrical stimulation to the mid- to
high-frequency region of the cochlea and acoustic amplification to the
low-frequency regions, for candidates with residual low frequency
hearing sensitivity. The MED-EL EAS is indicated for partially deaf
individuals aged 18 years and older who have residual hearing
sensitivity in the low frequencies sloping to a severe/profound
sensorineural hearing loss in the mid to high frequencies, and who
obtain minimal benefit from conventional acoustic amplification.
Subsequent to this approval, the USPTO received a patent term
restoration application for MED-EL EAS (U.S. Patent No. 7,917,224) from
Med-El Electromedizinische Gerate GmbH, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated April 5, 2018, FDA advised the USPTO
that this medical device had undergone a regulatory review period and
that the approval of MED-EL EAS represented the first permitted
commercial marketing or use of this 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
MED-EL EAS is 4,537 days. Of this time, 4,269 days occurred during the
testing phase of the regulatory review period, while 268 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: April 16, 2004. 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 2, 2004. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
April 16, 2004, 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): December
23, 2015. FDA has verified the applicant's claim that the premarket
approval application (PMA) for MED-EL EAS (PMA P000025 S084) was
initially submitted December 23, 2015.
3. The date the application was approved: September 15, 2016. FDA
has verified the applicant's claim that PMA P000025 S084 was approved
on September 15, 2016.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension.
[[Page 50044]]
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 998 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: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20657 Filed 9-23-19; 8:45 am]
BILLING CODE 4164-01-P
