Determination of Regulatory Review Period for Purposes of Patent Extension; LUXTURNA, 66682-66684 [2019-26252]
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the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. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Margaret Kober, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5376,
Silver Spring, MD 20993–0002, 301–
796–0934.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Interstitial Cystitis/Bladder Pain
Syndrome (IC/BPS): Establishing
Effectiveness of Drugs for Treatment.’’
IC/BPS is a complex, poorly understood
syndrome of unknown etiology. This
draft guidance provides
recommendations for establishing
effectiveness for drugs intended to treat
patients with IC/BPS. This draft
guidance incorporates recommendations
the FDA received at a December 2017
advisory committee meeting on trial
design features (see the meeting material
available at https://www.fda.gov/
advisory-committees/advisorycommittee-calendar/december-7-2017meeting-bone-reproductive-andurologic-drugs-advisory-committee12062017-12062017), including
enrollment criteria and acceptable
efficacy endpoints for drugs intended to
treat IC/BPS.
This draft guidance includes key
considerations in trial design including
enrollment criteria and efficacy
endpoint selection. The draft guidance
also provides general recommendations
on design features and statistical
considerations. This draft guidance also
provides the FDA’s current
recommendations on the use of patientreported outcome instruments to
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evaluate patient symptoms to
demonstrate a clinically meaningful
change with treatment.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Interstitial Cystitis/Bladder Pain
Syndrome (IC/BPS): Establishing
Effectiveness of Drugs for Treatment.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: November 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26264 Filed 12–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–E–2596]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LUXTURNA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for LUXTURNA 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
SUMMARY:
PO 00000
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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 February 3, 2020.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
June 2, 2020. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 3,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 3, 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
E:\FR\FM\05DEN1.SGM
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jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
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–E–2596 for ’’Determination of
Regulatory Review Period for Purposes
of Patent Extension; LUXTURNA.’’
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
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17:38 Dec 04, 2019
Jkt 250001
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
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
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 LUXTURNA
(voretigene neparvovec-rzyl).
LUXTURNA is indicated for treatment
of patients with confirmed biallelic
RPE65 mutation-associated retinal
dystrophy. Subsequent to this approval,
the USPTO received a patent term
restoration application for LUXTURNA
(U.S. Patent No. 9,433,688) from
Trustees of the University of
Pennsylvania, the University of Florida
Research Foundation, Inc., and Cornell
Research Foundation, Inc., and the
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66683
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
May 13, 2019, FDA advised the USPTO
that this human biological product had
undergone a regulatory review period
and that the approval of LUXTURNA
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
LUXTURNA is 3,809 days. Of this time,
3,591 days occurred during the testing
phase of the regulatory review period,
while 218 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 18, 2007. FDA has
verified the applicant’s claim that the
date the investigational new drug
application became effective was on
July 18, 2007.
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): May 16, 2017. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
LUXTURNA (BLA 125610) was initially
submitted on May 16, 2017.
3. The date the application was
approved: December 19, 2017. FDA has
verified the applicant’s claim that BLA
125610 was approved on December 19,
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 application for patent extension,
this applicant seeks 344 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
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
§ 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.
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: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26252 Filed 12–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Autism Spectrum
Disorder (ASD) Research Portfolio
Analysis, NIMH
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
SUMMARY:
Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: The Office of
Autism Research Coordination, NIMH,
NIH, Neuroscience Center, 6001
Executive Boulevard, MSC 9663, Room
6184, Bethesda, Maryland 20892 or can
email your request, including your
address to: iaccpublicinquiries@
mail.nih.gov or
nimhprapubliccomments@mail.nih.gov
or can call Melba O. Rojas, NIMH, NIH
at 301–402–0279. Formal requests for
additional plans and instruments must
be requested in writing.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on October 3, 2019, page 52888
(84 FR 52888) and allowed 60 days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institute of Mental Health (NIMH),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
DATES:
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Autism
Spectrum Disorder (ASD) Research
Portfolio Analysis, NIMH, 0925–0682,
expiration date 12/31/2019,
EXTENSION, National Institute of
Mental Health (NIMH), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The purpose of the ASD
research portfolio analysis is to collect
research funding data from U.S. and
international ASD research funders, to
assist the Interagency Autism
Coordinating Committee (IACC) in
fulfilling the requirements of the Autism
Collaboration, Accountability, Research,
Education and Support (CARES) Act of
2019, and to inform the committee and
interested stakeholders of the funding
landscape and current directions for
ASD research. Specifically, these
analyses will continue to examine the
extent to which current funding and
research topics align with the IACC
Strategic Plan for ASD Research. The
findings will help guide future funding
priorities by outlining current gaps and
opportunities in ASD research as well as
serving to highlight annual activities
and research progress.
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
714.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
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Type of respondents
Number of
projects per
respondent
Average time
per response
(in hours)
Total
burden
hours
U.S. Federal ......................................................................................................................................
U.S. Private .......................................................................................................................................
Individuals/households—International Government ..........................................................................
Individuals/households—International Private ..................................................................................
25
9
1
2
88
63
61
13
15/60
15/60
15/60
15/60
550
142
15
7
Total ...........................................................................................................................................
........................
1434
........................
714
Dated: November 27, 2019.
Melba O. Rojas,
Project Clearance Liaison, National Institute
of Mental Health, National Institutes of
Health.
[FR Doc. 2019–26260 Filed 12–4–19; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66682-66684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26252]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-E-2596]
Determination of Regulatory Review Period for Purposes of Patent
Extension; LUXTURNA
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 LUXTURNA 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
February 3, 2020. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 2, 2020.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 3, 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
[[Page 66683]]
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-E-2596 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; LUXTURNA.'' 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 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 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 LUXTURNA
(voretigene neparvovec-rzyl). LUXTURNA is indicated for treatment of
patients with confirmed biallelic RPE65 mutation-associated retinal
dystrophy. Subsequent to this approval, the USPTO received a patent
term restoration application for LUXTURNA (U.S. Patent No. 9,433,688)
from Trustees of the University of Pennsylvania, the University of
Florida Research Foundation, Inc., and Cornell Research Foundation,
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated May
13, 2019, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of LUXTURNA
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
LUXTURNA is 3,809 days. Of this time, 3,591 days occurred during the
testing phase of the regulatory review period, while 218 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 18,
2007. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 18,
2007.
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): May 16, 2017. FDA has verified the
applicant's claim that the biologics license application (BLA) for
LUXTURNA (BLA 125610) was initially submitted on May 16, 2017.
3. The date the application was approved: December 19, 2017. FDA
has verified the applicant's claim that BLA 125610 was approved on
December 19, 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 application for patent extension,
this applicant seeks 344 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
[[Page 66684]]
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: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26252 Filed 12-4-19; 8:45 am]
BILLING CODE 4164-01-P
