Determination of Regulatory Review Period for Purposes of Patent Extension; AVYCAZ, 2449-2451 [2018-00678]
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Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
ethrower on DSK3G9T082PROD with NOTICES
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10494 Exchange Functions:
Standards for Navigators and NonNavigator Assistance Personnel—
CAC
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision of a previously
approved collection; Title of
Information Collection: Exchange
Functions: Standards for Navigators and
Non-Navigator Assistance Personnel—
CAC; Use: Section 1321(a)(1) of the
Affordable Care Act directs and
authorizes the Secretary to issue
regulations setting standards for meeting
the requirements under title I of the
Affordable Care Act, with respect to,
among other things, the establishment
and operation of Exchanges. Pursuant to
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17:14 Jan 16, 2018
Jkt 244001
this authority, regulations establishing
the certified application counselor
program have been finalized at 45 CFR
155.225. In accordance with
155.225(d)(1) and (7), certified
application counselors in all Exchanges
are required to be initially certified and
recertified on at least an annual basis
and successfully complete Exchangerequired training. Form Number: CMS–
10494 (OMB control number: 0938–
1205); Frequency: On Occasion;
Affected Public: State, Local, or Tribal
Governments, Private Sector (not-forprofit institutions); individuals or
households; Number of Respondents:
30,000; Total Annual Responses:
30,000; Total Annual Hours: 7,500. For
policy questions regarding this
collection contact Deborah Bryant at
301–492–5213.
Dated: January 10, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–00632 Filed 1–16–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–1235]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; AVYCAZ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for AVYCAZ 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 drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by March 19, 2018.
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
DATES:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
2449
July 16, 2018. See ‘‘Petitions’’ in the
section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 19,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of March 19, 2018. 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.
SUPPLEMENTARY INFORMATION
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–
2016–E–1235 for ‘‘Determination of
E:\FR\FM\17JAN1.SGM
17JAN1
2450
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
ethrower on DSK3G9T082PROD with NOTICES
Regulatory Review Period for Purposes
of Patent Extension; AVYCAZ.’’
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,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
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17:14 Jan 16, 2018
Jkt 244001
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 AVYCAZ
(ceftazidime pentahydrate and
avibactam sodium). AVYCAZ is
indicated for treatment of patients 18
years or older with the following
infections caused by designated
susceptible microorganisms:
• Complicated intra-abdominal
infections used in combination with
metronidazole and
• Complicated urinary tract
infections, including pyelonephritis.
Subsequent to this approval, the
USPTO received a patent term
restoration application for AVYCAZ
(U.S. Patent No. 7,112,592) from Forest
Laboratories Holdings Ltd., and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
July 12, 2016, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of AVYCAZ
represented the first permitted
commercial marketing or use of the
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
AVYCAZ is 2,579 days. Of this time,
2,333 days occurred during the testing
phase of the regulatory review period,
while 246 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 (the FD&C Act) (21
U.S.C. 355(i)) became effective:
February 5, 2008. FDA has verified the
applicant’s claim that February 5, 2008,
is the date the investigational new drug
application (IND) became effective.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: June 25, 2014.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
AVYCAZ (NDA 206494) was initially
submitted on June 25, 2014.
3. The date the application was
approved: February 25, 2015. FDA has
verified the applicant’s claim that NDA
206494 was approved on February 25,
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 1,411 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
E:\FR\FM\17JAN1.SGM
17JAN1
Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00678 Filed 1–16–18; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–7012]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Use of Public
Human Genetic Variant Databases To
Support Clinical Validity for Genetic
and Genomic-Based In Vitro
Diagnostics
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—NEW and
title ‘‘Use of Public Human Genetic
Variant Databases to Support Clinical
Validity for Genetic and Genomic-Based
In Vitro Diagnostics.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
ADDRESSES:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
16, 2018.
SUMMARY:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Use of Public Human Genetic Variant
Databases To Support Clinical Validity
for Genetic and Genomic-Based In
Vitro Diagnostics—OMB Control
Number 0910—NEW
This information collection supports
the above captioned Agency guidance
document. In the Federal Register of
July 8, 2016 (81 FR 44611), FDA
announced the availability of a draft
guidance for industry entitled ‘‘Use of
Public Human Genetic Variant
Databases To Support Clinical Validity
for Next Generation Sequencing (NGS)Based In Vitro Diagnostics,’’ and
2451
included an analysis of the associated
information collection.
The draft guidance described FDA’s
considerations in determining whether a
genetic variant database is a source of
valid scientific evidence that could
support the clinical validity of an NGSbased test. This draft guidance further
outlines the process by which
administrators 1 of genetic variant
databases could voluntarily apply to
FDA for recognition, and how FDA
would review such applications and
periodically reevaluate recognized
databases. The draft guidance also
recommends that, at the time of
recognition, the database administrator
make information regarding policies,
procedures, and conflicts of interest
publicly available and accessible on the
genetic variant database’s website.
Based on our experience and the
nature of the information, we estimate
that it will take an average of 80 hours
to complete and submit an application
for recognition. We estimate that
maintenance of recognition activities
will take approximately one-fourth of
that time (20 hours) annually. We
estimate that it will take approximately
1 hour to post the information on the
website.
Respondents are administrators of
genetic databases. Our estimate of five
respondents per year is based on the
current number of databases that may
meet FDA recommendations for
recognition and seek such recognition.
FDA received 36 comments on the
draft guidance, none of which pertained
to the information collection burden
estimate.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Application for recognition of genetic database ..................
5
1
5
80
400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
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Activity
Number of
recordkeepers
Number of
records
per recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Maintenance of recognition activities ...................................
5
1
5
20
100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
1 FDA acknowledges that many databases may not
use the term ‘‘administrator’’ or may have a
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17:14 Jan 16, 2018
Jkt 244001
committee of individuals that oversee the database.
Therefore, for the purpose of this guidance, a
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Fmt 4703
Sfmt 4703
genetic variant database administrator is the entity
or entities that oversee database operations.
E:\FR\FM\17JAN1.SGM
17JAN1
]]>Agencies
[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2449-2451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00678]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-E-1235]
Determination of Regulatory Review Period for Purposes of Patent
Extension; AVYCAZ
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 AVYCAZ 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 drug
product.
DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
19, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by July 16, 2018. 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 March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 19, 2018. 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 No.
FDA-2016-E-1235 for ``Determination of
[[Page 2450]]
Regulatory Review Period for Purposes of Patent Extension; AVYCAZ.''
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 AVYCAZ
(ceftazidime pentahydrate and avibactam sodium). AVYCAZ is indicated
for treatment of patients 18 years or older with the following
infections caused by designated susceptible microorganisms:
Complicated intra-abdominal infections used in combination
with metronidazole and
Complicated urinary tract infections, including
pyelonephritis.
Subsequent to this approval, the USPTO received a patent term
restoration application for AVYCAZ (U.S. Patent No. 7,112,592) from
Forest Laboratories Holdings Ltd., and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated July 12, 2016, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of AVYCAZ 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
AVYCAZ is 2,579 days. Of this time, 2,333 days occurred during the
testing phase of the regulatory review period, while 246 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: February 5, 2008. FDA has verified the applicant's claim
that February 5, 2008, is the date the investigational new drug
application (IND) became effective.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 25,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for AVYCAZ (NDA 206494) was initially submitted on
June 25, 2014.
3. The date the application was approved: February 25, 2015. FDA
has verified the applicant's claim that NDA 206494 was approved on
February 25, 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 1,411 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.)
[[Page 2451]]
Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00678 Filed 1-16-18; 8:45 am]
BILLING CODE 4164-01-P
