Determination of Regulatory Review Period for Purposes of Patent Extension; NATPARA, 27496-27497 [2017-12359]
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27496
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12353 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–0118]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NATPARA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NATPARA 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 biological 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 August 14, 2017.
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
December 12, 2017. 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 August 14,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 14, 2017.
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.
pmangrum on DSK3GDR082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–0118 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; NATPARA.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
E:\FR\FM\15JNN1.SGM
15JNN1
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
pmangrum on DSK3GDR082PROD with NOTICES
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
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 biological 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 biologic product NATPARA
(parathyroid hormone (recombinant
human)). NATPARA is indicated as an
adjunct to calcium and vitamin D to
control hypocalcemia in patients with
hypoparathyroidism. Subsequent to this
approval, the USPTO received a patent
term restoration application for
NATPARA (U.S. Patent No. 5,496,801)
from NPS Pharmaceuticals Inc., and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
March 10, 2016, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
NATPARA 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
NATPARA is 7,268 days. Of this time,
6,811 days occurred during the testing
phase of the regulatory review period,
while 457 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 (21 U.S.C. 355(i))
became effective: March 3, 1995. The
applicant claims January 31, 1995, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was March 3, 1995,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): October 24, 2013. FDA has
verified the applicant’s claim that the
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
biologics license application (BLA) for
NATPARA (BLA 125511) was initially
submitted on October 24, 2013.
3. The date the application was
approved: January 23, 2015. FDA has
verified the applicant’s claim that BLA
125511 was approved on January 23,
2015.
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 5 years of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). 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. To meet its burden, the petition
must be timely (see ADDRESSES) and
contain sufficient facts to merit an FDA
investigation. (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
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12359 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
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27497
in participating in the selection of
voting and/or nonvoting consumer
representatives to serve on its advisory
committees or panels notify FDA in
writing. FDA is also requesting
nominations for voting and/or
nonvoting consumer representatives to
serve on advisory committees and/or
panels for which vacancies currently
exist or are expected to occur in the near
future. Nominees recommended to serve
as a voting or nonvoting consumer
representative may be self-nominated or
may be nominated by a consumer
organization.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by July 17, 2017, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by July 17, 2017.
Nominations will be accepted for
current vacancies and for those that will
or may occur through November 30,
2017.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should be submitted
electronically to ACOMSSubmissions@
fda.hhs.gov, by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5103, Silver Spring, MD 20993–
0002, or by FAX: 301–847–8640.
Consumer representative nominations
should be submitted electronically by
logging into the FDA Advisory
Committee Membership Nomination
Portal at: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm, by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, or by
FAX: 301–847–8640. Additional
information about becoming a member
on an FDA advisory committee can also
be obtained by visiting FDA’s Web site
at https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: For
questions relating to participation in the
E:\FR\FM\15JNN1.SGM
15JNN1
Agencies
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27496-27497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-E-0118]
Determination of Regulatory Review Period for Purposes of Patent
Extension; NATPARA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NATPARA 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 biological 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 August
14, 2017. 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 December 12, 2017.
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 August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 14, 2017. 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-0118 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NATPARA.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management 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 Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase
[[Page 27497]]
begins. The approval phase starts with the initial submission of an
application to market the human biological product and continues until
FDA grants permission to market the biological 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 biological 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 biologic product NATPARA
(parathyroid hormone (recombinant human)). NATPARA is indicated as an
adjunct to calcium and vitamin D to control hypocalcemia in patients
with hypoparathyroidism. Subsequent to this approval, the USPTO
received a patent term restoration application for NATPARA (U.S. Patent
No. 5,496,801) from NPS Pharmaceuticals Inc., and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated March 10, 2016, FDA advised the
USPTO that this human biological product had undergone a regulatory
review period and that the approval of NATPARA 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
NATPARA is 7,268 days. Of this time, 6,811 days occurred during the
testing phase of the regulatory review period, while 457 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 (21 U.S.C. 355(i)) became effective: March 3,
1995. The applicant claims January 31, 1995, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was March 3, 1995,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): October 24, 2013. FDA has verified the
applicant's claim that the biologics license application (BLA) for
NATPARA (BLA 125511) was initially submitted on October 24, 2013.
3. The date the application was approved: January 23, 2015. FDA has
verified the applicant's claim that BLA 125511 was approved on January
23, 2015.
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 5 years of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see ADDRESSES) and
contain sufficient facts to merit an FDA investigation. (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 Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12359 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P