Determination of Regulatory Review Period for Purposes of Patent Extension; MAVYRET, 3694-3696 [2020-00936]
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3694
Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Average
burden
per response
(in hours)
Total
burden hours
Physician ..............................................................................
CDC 4.422–1
200
1
10/60
33
Total ..............................................................................
........................
........................
........................
........................
33
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–01051 Filed 1–21–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0492]
Submission for OMB Review;
Community Services Block Grant
Annual Report
Office of Community Services;
Administration for Children and
Families; HHS.
ACTION: Request for public comment.
The Administration of
Children and Families (ACF), Office of
Community Services (OCS) is requesting
a three-year extension with minor
SUMMARY:
changes of the Community Services
Block Grant (CSBG) Annual Report
(OMB No.: 0970–0492, expiration 1/31/
2020). This request will support the
currently utilized CSBG Annual Report,
comprised of Modules 1–4, and
incorporates performance management.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Copies of the proposed collection may
be obtained by emailing infocollection@
ADDRESSES:
AGENCY:
Annual
number of
respondents
Instrument
CSBG Annual Report (States) .........................................................................
CSBG Annual Report (Eligible Entities) ..........................................................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: 112 Stat. 2729; 42 U.S.C.
9902(2).
Food and Drug Administration
[Docket Nos. FDA–2018–E–3053 and FDA–
2018–E–4226]
[FR Doc. 2020–00928 Filed 1–21–20; 8:45 am]
BILLING CODE 4184–27–P
Determination of Regulatory Review
Period for Purposes of Patent
Extension; MAVYRET
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for MAVYRET and is publishing this
notice of that determination as required
by law. FDA has made the
SUMMARY:
VerDate Sep<11>2014
16:42 Jan 21, 2020
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acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: Module 1 includes minor
edits to align with the updated, and
OMB approved, CSBG State Plan.
Module 2, Module 3, and Module 4
include only technical and grammatical
updates for ease and clarity of current
reporting. Copies of the proposed
collection of information can be
obtained by visiting: https://
www.acf.hhs.gov/programs/ocs/
programs/csbg.
Respondents: State governments,
including the District of Columbia and
the Commonwealth of Puerto Rico, and
U.S. territories and CSBG eligible
entities (Community Action Agencies).
Annual Burden Estimates:
Annual
number of
responses per
respondent
52
1,009
Estimated Total Annual Burden
Hours: 713,569.
Mary B. Jones,
ACF/OPRE Certifying Officer.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Form
1
1
Average
burden hours
per response
198
697
Annual burden
hours
10,296
703,273
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
patents which claims that human drug
product.
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 March 23, 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
July 20, 2020. See ‘‘Petitions’’ in the
DATES:
E:\FR\FM\22JAN1.SGM
22JAN1
Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Notices
Review Period for Purposes of Patent
Extension; MAVYRET.’’ 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
Electronic Submissions
information you claim to be confidential
Submit electronic comments in the
with a heading or cover note that states
following way:
• Federal eRulemaking Portal: https:// ‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
www.regulations.gov. Follow the
Agency will review this copy, including
instructions for submitting comments.
the claimed confidential information, in
Comments submitted electronically,
its consideration of comments. The
including attachments, to https://
second copy, which will have the
www.regulations.gov will be posted to
claimed confidential information
the docket unchanged. Because your
redacted/blacked out, will be available
comment will be made public, you are
solely responsible for ensuring that your for public viewing and posted on
https://www.regulations.gov. Submit
comment does not include any
both copies to the Dockets Management
confidential information that you or a
Staff. If you do not wish your name and
third party may not wish to be posted,
contact information to be made publicly
such as medical information, your or
anyone else’s Social Security number, or available, you can provide this
confidential business information, such information on the cover sheet and not
in the body of your comments and you
as a manufacturing process. Please note
must identify this information as
that if you include your name, contact
‘‘confidential.’’ Any information marked
information, or other information that
as ‘‘confidential’’ will not be disclosed
identifies you in the body of your
except in accordance with § 10.20 (21
comments, that information will be
CFR 10.20) and other applicable
posted on https://www.regulations.gov.
• If you want to submit a comment
disclosure law. For more information
with confidential information that you
about FDA’s posting of comments to
do not wish to be made available to the
public dockets, see 80 FR 56469,
public, submit the comment as a
September 18, 2015, or access the
written/paper submission and in the
information at: https://www.gpo.gov/
manner detailed (see ‘‘Written/Paper
fdsys/pkg/FR-2015-09-18/pdf/2015Submissions’’ and ‘‘Instructions’’).
23389.pdf.
Docket: For access to the docket to
Written/Paper Submissions
read background documents or the
Submit written/paper submissions as
electronic and written/paper comments
follows:
received, go to https://
• Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
written/paper submissions): Dockets
Management Staff (HFA–305), Food and docket number, found in brackets in the
heading of this document, into the
Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Dockets Management
• For written/paper comments
Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management
Rockville, MD 20852.
Staff, FDA will post your comment, as
well as any attachments, except for
FOR FURTHER INFORMATION CONTACT:
information submitted, marked and
Beverly Friedman, Office of Regulatory
identified, as confidential, if submitted
Policy, Food and Drug Administration,
as detailed in ‘‘Instructions.’’
10903 New Hampshire Ave., Bldg. 51,
Instructions: All submissions received
Rm. 6250, Silver Spring, MD 20993,
must include the Docket Nos. FDA–
301–796–3600.
2018–E–3053 and FDA–2018–E–4226
for ‘‘Determination of Regulatory
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
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 March 23,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 23, 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.
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3695
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 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 FDA grants
permission to market the drug product.
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 MAVYRET (a fixed
dose combination of glecaprevir, a
hepatitis C virus (HCV) NS3/4A
protease inhibitor, and pibrentasvir, an
HCV NS5A inhibitor). MAVYRET is
indicated for treatment of patients with
chronic HCV genotype 1, 2, 3, 4, 5 or 6
infection without cirrhosis and with
compensated cirrhosis (Child-Pugh A).
MAVYRET is also indicated for the
treatment of adult patients with HCV
genotype 1 infection, who previously
have been treated with a regimen
containing an HCV NS5A inhibitor or an
NS3/4A protease inhibitor, but not both.
Subsequent to this approval, the USPTO
received patent term restoration
applications for MAVYRET (U.S. Patent
Nos. 8,937,150 and 9,586,978) from
AbbVie, Inc., and the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated May 13,
2019, FDA advised the USPTO that this
human drug product had undergone a
regulatory review period and that the
E:\FR\FM\22JAN1.SGM
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3696
Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Notices
approval of MAVYRET represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
khammond on DSKJM1Z7X2PROD with NOTICES
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
MAVYRET is 1,725 days. Of this time,
1,492 days occurred during the testing
phase of the regulatory review period,
while 233 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: November 14,
2012. FDA has verified the applicant’s
claim that the date the investigational
new drug applications became effective
was on November 12, 2012.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: December 14,
2016. FDA has verified the applicant’s
claim that the new drug application
(NDA) for MAVYRET (NDA 209394)
was initially submitted on December 14,
2016.
3. The date the application was
approved: August 3, 2017. FDA has
verified the applicant’s claim that NDA
209394 was approved on August 3,
2017.
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 0 days or 150 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
VerDate Sep<11>2014
16:42 Jan 21, 2020
Jkt 250001
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: January 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00936 Filed 1–21–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: The Teaching
Health Center Graduate Medical
Education (THCGME) Program
Reconciliation Tool, OMB No. 0915–
0342—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 23, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
SUMMARY:
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information, please include the ICR title
for reference.
Information Collection Request Title:
The Teaching Health Center Graduate
Medical Education (THCGME) Program
Reconciliation Tool OMB No. 0915–
0342—Extension.
Abstract: The THCGME program,
authorized by Section 340H of the
Public Health Service Act, was
established by Section 5508 of Public
Law (Pub. L.) 111–148. The Bipartisan
Budget Act of 2018 (Pub. L. 115–123)
provided continued funding for the
THCGME Program for fiscal years 2018
and 2019 and the Further Consolidated
Appropriations Act, 2020 (Pub. L. 116–
94) extends funding for the THCGME
program until May 22, 2020.
The THCGME program awards
payment for both direct and indirect
expenses to support training for primary
care residents in community-based
ambulatory patient care settings. Direct
medical expense payments are designed
to compensate eligible THC for those
expenses directly associated with
resident training, while indirect medical
expense payments are intended to
compensate for the additional costs of
training residents in such programs.
Need and Proposed Use of the
Information: THCGME program
payments are prospective payments,
and the statute provides for a
reconciliation process, through which
overpayments may be recouped and
underpayments may be adjusted at the
end of the fiscal year. This data
collection instrument gathers
information relating to the number of
resident full-time equivalents in THC
training programs in order to reconcile
payments for both direct and indirect
expenses.
Likely Respondents: THCGME
program award recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
E:\FR\FM\22JAN1.SGM
22JAN1
]]>Agencies
[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Notices]
[Pages 3694-3696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00936]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-E-3053 and FDA-2018-E-4226]
Determination of Regulatory Review Period for Purposes of Patent
Extension; MAVYRET
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 MAVYRET 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 patents which claims that human drug
product.
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 March 23, 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 July 20, 2020. See ``Petitions''
in the
[[Page 3695]]
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 March 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 23, 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.
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-2018-E-3053 and FDA-2018-E-4226 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; MAVYRET.'' 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 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 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 FDA grants permission to market the drug product.
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 MAVYRET (a
fixed dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A
protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor). MAVYRET
is indicated for treatment of patients with chronic HCV genotype 1, 2,
3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis
(Child-Pugh A). MAVYRET is also indicated for the treatment of adult
patients with HCV genotype 1 infection, who previously have been
treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A
protease inhibitor, but not both. Subsequent to this approval, the
USPTO received patent term restoration applications for MAVYRET (U.S.
Patent Nos. 8,937,150 and 9,586,978) from AbbVie, Inc., and the USPTO
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated May 13, 2019, FDA advised
the USPTO that this human drug product had undergone a regulatory
review period and that the
[[Page 3696]]
approval of MAVYRET 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
MAVYRET is 1,725 days. Of this time, 1,492 days occurred during the
testing phase of the regulatory review period, while 233 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:
November 14, 2012. FDA has verified the applicant's claim that the date
the investigational new drug applications became effective was on
November 12, 2012.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
14, 2016. FDA has verified the applicant's claim that the new drug
application (NDA) for MAVYRET (NDA 209394) was initially submitted on
December 14, 2016.
3. The date the application was approved: August 3, 2017. FDA has
verified the applicant's claim that NDA 209394 was approved on August
3, 2017.
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 0 days or 150 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: January 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00936 Filed 1-21-20; 8:45 am]
BILLING CODE 4164-01-P
