Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT ORAL SOLUTION, New Drug Application 205838, 67942-67944 [2019-26814]
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67942
Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period;
Withdrawal.
AGENCY:
Notice.
HHS gives notice concerning
the final effect of the HHS decision to
designate a class of employees from the
West Valley Demonstration Project in
West Valley, New York, as an addition
to the Special Exposure Cohort (SEC)
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Grady Calhoun, Director, Division of
Compensation Analysis and Support,
NIOSH, 1090 Tusculum Avenue, MS C–
46, Cincinnati, OH 45226–1938,
Telephone 513–533–6800. Information
requests can also be submitted by email
to DCAS@CDC.GOV.
On
October 25, 2019, as provided for under
42 U.S.C. 7384l(14)(C), the Secretary of
HHS designated the following class of
employees as an addition to the SEC:
SUPPLEMENTARY INFORMATION:
All Atomic Weapons Employees who
worked at the West Valley Demonstration
Project in West Valley, New York, during the
period from January 1, 1969, through
December 31, 1973, for a number of work
days aggregating at least 250 work days,
occurring either solely under this
employment or in combination with work
days within the parameters established for
one or more other classes of employees in the
Special Exposure Cohort.
This designation became effective on
November 24, 2019. Therefore,
beginning on November 24, 2019,
members of this class of employees,
defined as reported in this notice,
became members of the SEC.
khammond on DSKJM1Z7X2PROD with NOTICES
[60Day–20–0020; Docket No. CDC–2019–
0109]
Authority: 42 U.S.C. 7384q(b). 42 U.S.C.
7384l(14)(C).
John J. Howard,
Director, National Institute for Occupational
Safety and Health.
The Centers for Disease
Control and Prevention (CDC) in the
Department of Health and Human
Services (HHS) announces the
withdrawal of the notice published
under the same title on December 6,
2019 for public comment.
DATES: December 12, 2019.
FOR FURTHER INFORMATION CONTACT:
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: On
December 6, 2019 CDC published a
notice in the Federal Register titled
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ (84 FR 66902). This
notice with Federal Register Document
2019–26370 and Docket number CDC–
2019–0109, was published prematurely
and inadvertently. The notice is being
withdrawn immediately for public
comment. A new notice will be
published at a later date for public
comment.
SUMMARY:
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–26692 Filed 12–11–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–2529]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BRIVIACT ORAL
SOLUTION, New Drug Application
205838
[FR Doc. 2019–26747 Filed 12–11–19; 8:45 am]
AGENCY:
BILLING CODE 4163–18–P
HHS.
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ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BRIVIACT ORAL SOLUTION and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
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 February 10, 2020.
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
June 9, 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 February 10,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 10, 2020.
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.
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
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.
E:\FR\FM\12DEN1.SGM
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Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices
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• 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–
2016–E–2529 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; BRIVIACT ORAL
SOLUTION.’’ 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 § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
VerDate Sep<11>2014
17:56 Dec 11, 2019
Jkt 250001
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.
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, if a patent is
eligible for extension under these acts,
the 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 human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until the drug
product ‘‘was approved’’ within the
meaning of 35 U.S.C. 156. In the case of
a drug recommended for controls under
the Controlled Substances Act (CSA),
for purposes of patent term extension, a
drug is considered to have been
approved on the later of the date the
application to market the drug is
approved or the date of issuance of the
interim final rule controlling the drug.
(See 35 U.S.C. 156(i)). Although only a
portion of a regulatory review period
may count toward the actual amount of
extension that the Director of USPTO
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67943
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 human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human drug product BRIVIACT ORAL
SOLUTION (brivaracetam) under new
drug application (NDA) 205838.
BRIVIACT ORAL SOLUTION is
indicated for adjunctive therapy in the
treatment of partial-onset seizures in
patients 16 years of age and older with
epilepsy. Subsequent to this approval,
the USPTO received a patent term
restoration application for BRIVIACT
ORAL SOLUTION (U.S. Patent No.
8,492,416) from UCB Biopharma SPRL
and the USPTO requested FDA’s
assistance in determining the patent’s
eligibility for patent term restoration. In
a letter dated January 18, 2017, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of BRIVIACT ORAL
SOLUTION 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
BRIVIACT ORAL SOLUTION is 4,293
days. Of this time, 3,753 days occurred
during the testing phase of the
regulatory review period, while 540
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: August 12,
2004. The applicant claims December
22, 2010, as the date the investigational
new drug application (IND) became
effective. However, according to FDA
records, this IND was not the first IND
received for this active ingredient. In
general, FDA has used the first IND
submitted for investigation of the active
ingredient of the drug product as the
beginning of the testing phase, if
information derived from this first IND
was or could have been relied on or was
relevant for approval to market the drug
product. FDA records indicate that the
effective date of the first IND for
brivaracetam was August 12, 2004,
which was 30 days after FDA receipt of
this first IND. This is the same IND and
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Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices
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the same date FDA determined was the
beginning of the regulatory review
period for BRIVIACT ORAL TABLETS
approved under NDA 205836 and for
BRIVIACT INJECTION approved under
NDA 205837. The regulatory review
period determinations for BRIVIACT
ORAL TABLETS and BRIVIACT
INJECTION are published in this issue
of the Federal Register.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: November 20,
2014. FDA has verified the applicant’s
claim that the NDA for BRIVIACT ORAL
SOLUTION (NDA 205838) was initially
submitted on November 20, 2014.
3. For a drug recommended for
controls under the CSA, the later of the
date the NDA was approved under
section 505 of the FD&C Act or the date
of issuance of the interim final rule
controlling the drug: May 12, 2016. FDA
has verified the applicant’s claim that
NDA 205838 was approved on February
18, 2016. FDA has also verified that the
date of issuance of the interim final rule
controlling the drug, placing BRIVIACT
ORAL SOLUTION (brivaracetam) in
schedule V of the CSA as revised by the
Improving Regulatory Transparency for
New Medical Therapies Act, was May
12, 2016.
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 698 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.
VerDate Sep<11>2014
17:56 Dec 11, 2019
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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: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26814 Filed 12–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0417]
Request for Nominations on the
National Mammography Quality
Assurance Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on the National Mammography
Quality Assurance Advisory Committee
in the Center for Devices and
Radiological Health notify FDA in
writing. FDA is also requesting
nominations for a nonvoting industry
representative to serve on the National
Mammography Quality Assurance
Advisory Committee. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current and upcoming vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by January 13, 2020 (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by January 13,
2020.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for a
nonvoting industry representative
SUMMARY:
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should be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Division of
Management Services, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5213,
Silver Spring, MD 20993, 301–796–
5960, Fax: 301–847–8505, email:
margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency is requesting nominations for a
nonvoting industry representative on
the National Mammography Quality
Assurance Advisory Committee:
I. General Description of the Committee
Duties
The Committee shall advise FDA on:
(1) Developing appropriate quality
standards and regulations for
mammography facilities; (2) developing
appropriate standards and regulations
for bodies accrediting mammography
facilities under this program; (3)
developing regulations with respect to
sanctions; (4) developing procedures for
monitoring compliance with standards;
(5) establishing a mechanism to
investigate consumer complaints; (6)
reporting new developments concerning
breast imaging that should be
considered in the oversight of
mammography facilities; (7)
determining whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
personnel on access to the services of
such facilities in these areas; (8)
determining whether there will exist a
sufficient number of medical physicists
after October 1, 1999; and (9)
determining the costs and benefits of
compliance with these requirements.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
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Agencies
[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Pages 67942-67944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-E-2529]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BRIVIACT ORAL SOLUTION, New Drug Application 205838
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 BRIVIACT ORAL SOLUTION and
is publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
human drug product.
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
February 10, 2020. 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 June 9, 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 February 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 10, 2020. 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.
[[Page 67943]]
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-2016-E-2529 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; BRIVIACT ORAL SOLUTION.'' 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 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.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, if a patent
is eligible for extension under these acts, the 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 human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until the drug product ``was approved'' within the meaning of
35 U.S.C. 156. In the case of a drug recommended for controls under the
Controlled Substances Act (CSA), for purposes of patent term extension,
a drug is considered to have been approved on the later of the date the
application to market the drug is approved or the date of issuance of
the interim final rule controlling the drug. (See 35 U.S.C. 156(i)).
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 human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product BRIVIACT ORAL
SOLUTION (brivaracetam) under new drug application (NDA) 205838.
BRIVIACT ORAL SOLUTION is indicated for adjunctive therapy in the
treatment of partial-onset seizures in patients 16 years of age and
older with epilepsy. Subsequent to this approval, the USPTO received a
patent term restoration application for BRIVIACT ORAL SOLUTION (U.S.
Patent No. 8,492,416) from UCB Biopharma SPRL and the USPTO requested
FDA's assistance in determining the patent's eligibility for patent
term restoration. In a letter dated January 18, 2017, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of BRIVIACT ORAL SOLUTION 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
BRIVIACT ORAL SOLUTION is 4,293 days. Of this time, 3,753 days occurred
during the testing phase of the regulatory review period, while 540
days occurred during the approval phase. These periods of time were
derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
August 12, 2004. The applicant claims December 22, 2010, as the date
the investigational new drug application (IND) became effective.
However, according to FDA records, this IND was not the first IND
received for this active ingredient. In general, FDA has used the first
IND submitted for investigation of the active ingredient of the drug
product as the beginning of the testing phase, if information derived
from this first IND was or could have been relied on or was relevant
for approval to market the drug product. FDA records indicate that the
effective date of the first IND for brivaracetam was August 12, 2004,
which was 30 days after FDA receipt of this first IND. This is the same
IND and
[[Page 67944]]
the same date FDA determined was the beginning of the regulatory review
period for BRIVIACT ORAL TABLETS approved under NDA 205836 and for
BRIVIACT INJECTION approved under NDA 205837. The regulatory review
period determinations for BRIVIACT ORAL TABLETS and BRIVIACT INJECTION
are published in this issue of the Federal Register.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: November
20, 2014. FDA has verified the applicant's claim that the NDA for
BRIVIACT ORAL SOLUTION (NDA 205838) was initially submitted on November
20, 2014.
3. For a drug recommended for controls under the CSA, the later of
the date the NDA was approved under section 505 of the FD&C Act or the
date of issuance of the interim final rule controlling the drug: May
12, 2016. FDA has verified the applicant's claim that NDA 205838 was
approved on February 18, 2016. FDA has also verified that the date of
issuance of the interim final rule controlling the drug, placing
BRIVIACT ORAL SOLUTION (brivaracetam) in schedule V of the CSA as
revised by the Improving Regulatory Transparency for New Medical
Therapies Act, was May 12, 2016.
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 698 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: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26814 Filed 12-11-19; 8:45 am]
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