Determination of Regulatory Review Period for Purposes of Patent Extension; NUWIQ, 85974-85976 [2016-28654]
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85974
Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
Guidance for Industry on Expedited
Programs for Serious Conditions—
Drugs and Biologics OMB Control
Number 0910–0765—Extension
FDA has established four programs
intended to facilitate and expedite
development and review of new drugs
to address unmet medical needs in the
treatment of serious or life-threatening
conditions: (1) Fast track designation
including rolling review, (2)
breakthrough therapy designation, (3)
accelerated approval, and (4) priority
review designation. In support of these
programs, the Agency has developed the
guidance document, ‘‘Guidance For
Industry: Expedited Programs for
Serious Conditions—Drugs and
Biologics.’’ The guidance outlines the
programs’ policies and procedures and
describes applicable threshold criteria,
including when to submit information
to FDA. Respondents to the information
collection are sponsors of drug and
biological products appropriate for these
expedited programs.
Priority Review Designation Request.
The guidance describes that a sponsor
may expressly request priority review of
an application. Based on information
from FDA’s databases and information
available to FDA, we estimate that
approximately 48 sponsors will prepare
and submit approximately 1.7 priority
review designation submissions that
receive a priority review in accordance
with the guidance and that the added
burden for each submission will be
approximately 30 hours to develop and
submit to FDA as part of the application
(totaling 2,400 hours).
Breakthrough Therapy Designation
Request. The guidance describes the
process for sponsors to request
breakthrough therapy designation in an
application. Based on information from
FDA’s databases and information
available to FDA, we estimate that
approximately 87 sponsors will prepare
approximately 1.29 breakthrough
therapy designation submissions in
accordance with the guidance and that
the added burden for each submission
will be approximately 70 hours to
prepare and submit (totaling 7,910
hours).
Accordingly, we estimate the burden
of this information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Guidance on expedited programs
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Priority Review Designation Request ..................................
Breakthrough Therapy Designation Request ......................
48
87
1.7
1.29
80
113
30
70
2,400
7,910
Total ..............................................................................
........................
........................
........................
........................
10,310
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
parts 202.1, 314, and 601, and sections
505(a), 506(a)(1), 735, and 736 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(a), 356(a)(1), 379(g), and
379(h)) have been approved under OMB
control numbers 0910–0686, 0910–0001,
0910–0338, 0910–0014, and 0910–0297.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28732 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2016–E–0622]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NUWIQ
AGENCY:
Electronic Submissions
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for NUWIQ
SUMMARY:
VerDate Sep<11>2014
17:48 Nov 28, 2016
Jkt 241001
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 January 30, 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
May 30, 2017. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
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
PO 00000
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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,
E:\FR\FM\29NON1.SGM
29NON1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–E–0622 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; NUWIQ.’’ 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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,
VerDate Sep<11>2014
17:48 Nov 28, 2016
Jkt 241001
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 becomes effective and runs
until the approval phase 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 NUWIQ
(Antihemophilic Factor (Recombinant)).
NUWIQ is indicated for adults and
children with Hemophilia A for:
• On-demand treatment and control
of bleeding episodes;
• perioperative management of
bleeding;
• routine prophylaxis to reduce the
frequency of bleeding episodes.
Subsequent to this approval, the USPTO
received a patent term restoration
application for NUWIQ (U.S. Patent No.
7,572,619) from Octapharma AG, and
the USPTO requested FDA’s assistance
in determining this patent’s eligibility
for patent term restoration. In a letter
dated April 20, 2016, FDA advised the
USPTO that this human biological
product had undergone a regulatory
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85975
review period and that the approval of
NUWIQ 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
NUWIQ is 2,622 days. Of this time,
2,165 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: July 2, 2008. FDA has
verified the applicant’s claim that the
date the investigational new drug
application became effective was on
July 2, 2008.
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): June 5, 2014. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
NUWIQ (BLA 125555/0) was initially
submitted on June 5, 2014.
3. The date the application was
approved: September 4, 2015. FDA has
verified the applicant’s claim that BLA
125555/0 was approved on September 4,
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 1,336 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 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 DATES) 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
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85976
Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
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: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28654 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0349]
Providing Postmarketing Periodic
Safety Reports in the International
Council for Harmonisation E2C(R2)
Format (Periodic Benefit-Risk
Evaluation Report); Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
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’’).
HHS.
Written/Paper Submissions
Submit written/paper submissions as
follows:
SUMMARY: The Food and Drug
• Mail/Hand delivery/Courier (for
Administration (FDA or Agency) is
written/paper submissions): Division of
announcing the availability of a
Dockets Management (HFA–305), Food
guidance for industry entitled
and Drug Administration, 5630 Fishers
‘‘Providing Postmarketing Periodic
Lane, Rm. 1061, Rockville, MD 20852.
Safety Reports in the ICH E2C(R2)
• For written/paper comments
Format (Periodic Benefit-Risk
submitted to the Division of Dockets
Evaluation Report).’’ This guidance is
Management, FDA will post your
intended to inform applicants of the
comment, as well as any attachments,
conditions under which FDA will
except for information submitted,
exercise its waiver authority to permit
marked and identified, as confidential,
applicants to submit an International
if submitted as detailed in
Council for Harmonisation (ICH)
‘‘Instructions.’’
(formerly International Conference on
Instructions: All submissions received
Harmonisation) E2C(R2) Periodic
must include the Docket No. FDA–
Benefit-Risk Evaluation Report (PBRER) 2013–D–0349 for ‘‘Providing
in place of the ICH E2C(R1) Periodic
Postmarketing Periodic Safety Reports
Safety Update Report (PSUR), U.S.
in the ICH E2C(R2) Format (Periodic
Periodic adverse drug experience report Benefit-Risk Evaluation Report).’’
(PADER), or U.S. Periodic adverse
Received comments will be placed in
experience report (PAER), to satisfy the
the docket and, except for those
periodic safety reporting requirements
submitted as ‘‘Confidential
in FDA regulations. The guidance
Submissions,’’ publicly viewable at
describes the steps applicants can take
https://www.regulations.gov/ or at the
to submit the PBRER, and discusses the
Division of Dockets Management
format, content, submission deadline,
between 9 a.m. and 4 p.m., Monday
and frequency of reporting for the
through Friday.
PBRER.
• Confidential Submissions—To
submit a comment with confidential
DATES: Submit either electronic or
information that you do not wish to be
written comments on the guidance at
made publicly available, submit your
any time.
comments only as a written/paper
ADDRESSES: You may submit comments
submission. You should submit two
as follows:
copies total. One copy will include the
Electronic Submissions
information you claim to be confidential
with a heading or cover note that states
Submit electronic comments in the
‘‘THIS DOCUMENT CONTAINS
following way:
• Federal eRulemaking Portal: https:// CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
www.regulations.gov/. Follow the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice of availability.
VerDate Sep<11>2014
17:48 Nov 28, 2016
Jkt 241001
PO 00000
Frm 00057
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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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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.
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Jean
Chung, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4466, Silver Spring,
MD 20993–0002, 301–796–2380; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration,10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\29NON1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85974-85976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28654]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-E-0622]
Determination of Regulatory Review Period for Purposes of Patent
Extension; NUWIQ
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NUWIQ 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 January
30, 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 May 30, 2017. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): 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,
[[Page 85975]]
marked and identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-E-0622 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NUWIQ.'' 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 becomes effective and runs until the
approval phase 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 NUWIQ
(Antihemophilic Factor (Recombinant)). NUWIQ is indicated for adults
and children with Hemophilia A for:
On-demand treatment and control of bleeding episodes;
perioperative management of bleeding;
routine prophylaxis to reduce the frequency of bleeding
episodes.
Subsequent to this approval, the USPTO received a patent term
restoration application for NUWIQ (U.S. Patent No. 7,572,619) from
Octapharma AG, and the USPTO requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated April 20, 2016, FDA advised the USPTO that this human biological
product had undergone a regulatory review period and that the approval
of NUWIQ 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
NUWIQ is 2,622 days. Of this time, 2,165 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: July 2,
2008. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 2,
2008.
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): June 5, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
NUWIQ (BLA 125555/0) was initially submitted on June 5, 2014.
3. The date the application was approved: September 4, 2015. FDA
has verified the applicant's claim that BLA 125555/0 was approved on
September 4, 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 1,336 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 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 DATES) 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
[[Page 85976]]
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: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28654 Filed 11-28-16; 8:45 am]
BILLING CODE 4164-01-P
