Determination of Regulatory Review Period for Purposes of Patent Extension; NERLYNX, 45769-45771 [2019-18816]
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45769
Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices
until the new IC is approved and ready
for usage.
The Older Americans Act (OAA)
requires annual program performance
reports from States, the District of
Columbia, and Territories. In
compliance with this OAA provision,
ACL developed a SPR in 1996 as part of
its National Aging Program Information
System (NAPIS). The SPR collects
information about how State Agencies
on Aging expend their OAA funds as
well as funding from other sources for
OAA authorized supportive services.
The SPR also collects information on
the demographic and functional status
of the recipients, and is a key source for
ACL performance measurement. The
information submitted by Title III
grantees is AoA’s principle source for
data and information on programs and
services funded under the Older
Americans Act (OAA). The SPR serves
as the Program Performance Report for
the state grantees to meet their annual
grantee reporting requirements and
includes the data required by the OAA
be reported in the AoA Annual Report
to Congress. This IC is summary data of
services for seniors provided or
managed by State Units on Aging (SUA)
and Area Agencies on Aging (AAA).
Data is submitted annually by the 50
states, four Territories (American
Samoa, Guam, Puerto Rico, and Virgin
Islands), and Washington, DC. The SPR
includes information on the number of
people served, the number of units of
specific services, Title III expenditures,
total expenditures, number of state and
local staff, number of providers, and
major accomplishments.
Data from the SPR are the primary
source for performance measures in the
Congressional budget justification, the
HHS Annual Performance Plan and
Report as well as the Annual Report to
Congress.
Respondent/data
collection activity
Estimated Program Burden
ACL estimates the burden associated
with this collection of information as
follows: 2,750 annual burden hours.
Responses
per
respondent
Hours per
response
Annual
burden hours
SPR ..................................................................................................................
55
1
50
2,750
Total ..........................................................................................................
55
1
50
2,750
Dated: August 20, 2019.
Mary Lazare,
Principal Deputy Administrator.
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–D–2991]
Pediatric Rare Diseases—A
Collaborative Approach for Drug
Development Using Gaucher Disease
as a Model; Draft Guidance for
Industry; Availability; Correction
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Pediatric Rare Diseases—A
Collaborative Approach for Drug
Development Using Gaucher Disease as
a Model; Draft Guidance for Industry;
Availability’’ that appeared in the
Federal Register of December 7, 2017.
The document announced the
availability of a draft guidance focusing
on drug development for pediatric
patients with Gaucher disease. The
document was published with the
SUMMARY:
VerDate Sep<11>2014
16:43 Aug 29, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Lisa
Granger, Office of Policy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3330, Silver Spring,
MD 20993–0002, 301–796–9115.
Food and Drug Administration
In the
Federal Register of Thursday, December
7, 2017 (82 FR 57759), in FR Doc. 2017–
26357, the following correction is made:
On page 57759, in the first column, in
the document heading and in the third
column under Instructions, the docket
number ‘‘FDA–2017–N–6476’’ is
corrected to read ‘‘FDA–2017–D–2991’’.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2019–18842 Filed 8–29–19; 8:45 am]
jspears on DSK3GMQ082PROD with NOTICES
Number of
respondents
AoA also uses the data to respond to
inquiries from stakeholders, the public,
press, program and policy decision
makers. Information from the most
recent SPR is available on-line on the
Aging Integrated Database (AGID).
Results are available annually.
The proposed FY 2020 version posts
on the ACL website link entitled
Proposed State Program Report (SPR)
Form 2020 Revision available at https://
acl.gov/programs/performance-olderamericans-act-programs
For review and comment on this
proposed information collection
request, please visit the ACL website
https://www.acl.gov/about-acl/publicinput.
Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18730 Filed 8–29–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
[Docket Nos. FDA–2018–E–0699 and FDA–
2018–E–0705]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NERLYNX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for NERLYNX and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
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 October 29, 2019.
Furthermore, any interested person may
DATES:
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Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 26, 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 October 29,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 29, 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
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
jspears on DSK3GMQ082PROD 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
VerDate Sep<11>2014
16:43 Aug 29, 2019
Jkt 247001
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2018–E–0699 and FDA–2018–E–0705
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; NERLYNX.’’ 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
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,
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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 NERLYNX
(neratinib), which is indicated for
extended adjuvant treatment of adult
patients with early stage HER2overexpressed/amplified breast cancer,
to follow adjuvant trastuzumab-based
therapy. Subsequent to this approval,
the USPTO received patent term
restoration applications for NERLYNX
(U.S. Patent Nos. 7,399,865 and
9,211,291) from Puma Biotechnology,
Inc., and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated April 5, 2018, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of NERLYNX represented the
first permitted commercial marketing or
use of the product. Thereafter, the
E:\FR\FM\30AUN1.SGM
30AUN1
Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices
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
NERLYNX is 5,102 days. Of this time,
4,738 days occurred during the testing
phase of the regulatory review period,
while 364 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: July 31, 2003.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
July 31, 2003.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: July 19, 2016.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
NERLYNX (NDA 208051) was initially
submitted on July 19, 2016.
3. The date the application was
approved: July 17, 2017. FDA has
verified the applicant’s claim that NDA
208051 was approved on July 17, 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 472 days or 1,826
days of patent term extension.
jspears on DSK3GMQ082PROD with NOTICES
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
16:43 Aug 29, 2019
Jkt 247001
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: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18816 Filed 8–29–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3130]
Consideration of Uncertainty in Making
Benefit-Risk Determinations in Medical
Device Premarket Approvals, De Novo
Classifications, and Humanitarian
Device Exemptions; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Consideration of
Uncertainty in Making Benefit-Risk
Determinations in Medical Device
Premarket Approvals, De Novo
Classifications, and Humanitarian
Device Exemptions.’’ This guidance
document describes FDA’s current
approach to considering uncertainty in
making benefit-risk determinations to
support certain FDA premarket
decisions for medical devices—
premarket approval applications
(PMAs), De Novo requests, and
humanitarian device exemption
applications. This guidance document
elaborates on the consideration of
uncertainty as part of our overarching
approach to a benefit-risk based
framework that is intended to assure
greater predictability, consistency, and
efficiency through the application of
least burdensome principles. This
guidance also provides examples of how
the principles for considering
uncertainty could be applied in the
context of clinical evidence and
circumstances where greater uncertainty
could be appropriate in premarket
decisions, balanced by postmarket
controls—PMAs for Breakthrough
Devices and PMAs for devices for small
patient populations.
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
45771
The announcement of the
guidance is published in the Federal
Register on August 30, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–3130 for ‘‘Consideration of
Uncertainty in Making Benefit-Risk
Determinations in Medical Device
Premarket Approvals, De Novo
Classifications, and Humanitarian
Device Exemptions; Guidance for
Industry and Food and Drug
Administration Staff; Availability.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
E:\FR\FM\30AUN1.SGM
30AUN1
]]>Agencies
[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45769-45771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18816]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-E-0699 and FDA-2018-E-0705]
Determination of Regulatory Review Period for Purposes of Patent
Extension; NERLYNX
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 NERLYNX and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that 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 October
29, 2019. Furthermore, any interested person may
[[Page 45770]]
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by February 26, 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 October 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 29, 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 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-0699 and FDA-2018-E-0705 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; NERLYNX.'' 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 NERLYNX
(neratinib), which is indicated for extended adjuvant treatment of
adult patients with early stage HER2-overexpressed/amplified breast
cancer, to follow adjuvant trastuzumab-based therapy. Subsequent to
this approval, the USPTO received patent term restoration applications
for NERLYNX (U.S. Patent Nos. 7,399,865 and 9,211,291) from Puma
Biotechnology, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated April 5, 2018, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of NERLYNX represented the first permitted commercial marketing or use
of the product. Thereafter, the
[[Page 45771]]
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
NERLYNX is 5,102 days. Of this time, 4,738 days occurred during the
testing phase of the regulatory review period, while 364 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:
July 31, 2003. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was July 31,
2003.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: July 19,
2016. FDA has verified the applicant's claim that the new drug
application (NDA) for NERLYNX (NDA 208051) was initially submitted on
July 19, 2016.
3. The date the application was approved: July 17, 2017. FDA has
verified the applicant's claim that NDA 208051 was approved on July 17,
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 472 days or 1,826 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: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18816 Filed 8-29-19; 8:45 am]
BILLING CODE 4164-01-P
