Determination of Regulatory Review Period for Purposes of Patent Extension; GAZYVA, 21579-21581 [2016-08338]
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21579
Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
under the U.S. Department of
Agriculture jurisdiction, are safe,
wholesome, and labeled properly. States
are responsible for conducting
inspections and regulatory activities
that help ensure food and feed
produced, processed, and distributed
within their jurisdictions are safe and in
compliance with State laws and
regulations. States primarily perform
inspections under their own regulatory
authority. Some States conduct
inspections of feed facilities under
contract with FDA. Because
jurisdictions may overlap, FDA and
States collaborate and share resources to
protect animal feed.
The FDA Food Safety Modernization
Act passed on January 4, 2011, calls for
enhanced partnerships and provides a
legal mandate for developing an
Integrated Food Safety System (IFSS).
FDA is committed to implementing an
IFSS thereby optimizing coordination of
food and feed safety efforts with
Federal, State, local, tribal, and
territorial regulatory and public health
agencies. Model standards provide a
consistent, underlying foundation that
is critical for uniformity across State
and Federal Agencies to ensure
credibility of food and feed programs
within the IFSS.
II. Significance of Feed Program
Standards
The AFRPS provide a uniform and
consistent approach to feed regulation
in the United States. Implementation of
the draft feed program standards is
voluntary. States implementing the
standards will identify and maintain
program improvements that will
strengthen the safety and integrity of the
U.S. animal feed supply.
The feed standards are the framework
that each State should use to design,
manage, and improve its feed program.
The standards include the following: (1)
Regulatory foundation; (2) training; (3)
inspection program; (4) auditing; (5)
feed-related illness or death and
emergency response; (6) enforcement
program; (7) outreach activities; (8)
budget and planning; (9) assessment and
improvement; (10) laboratory services;
and (11) sampling program.
Each standard has a purpose
statement, requirement summary,
description of program elements,
projected outcomes, and a list of
required documentation. When a State
program voluntarily agrees to
implement the feed standards, it must
fully implement and maintain the
individual program elements and
documentation requirements in each
standard in order to fully implement the
standard.
The feed standards package includes
forms, worksheets, and templates to
help the State program assess and meet
the program elements in the standard.
State programs are not obligated to use
the forms, worksheets, and templates
provided with the feed standards. Other
manual or automated forms, worksheets,
and templates may be used as long as
the pertinent data elements are present.
Records and other documents specified
in the feed standards must be
maintained in good order by the State
program and must be available to verify
the implementation of each standard.
The feed standards are not intended to
address the performance appraisal
processes that a State agency may use to
evaluate individual employee
performance.
In the first year of implementation,
the State program uses the selfassessment worksheets to determine if
the requirements for each standard are
fully met, partially met, or not met. The
self-assessments are used to develop an
improvement plan for fully
implementing the requirements of the
11 standards. Second and third-year
assessments will provide progress
evaluation.
Although FDA plans to provide
financial support to State programs that
implement the feed standards, funding
opportunities are contingent upon the
availability of funds. Funding
opportunities may be only available to
State feed regulatory programs that
currently have an FDA feed inspection
contract. State programs receiving
financial support to implement the feed
standards will be audited by FDA.
III. Electronic Access
Persons with access to the Internet
may submit requests for a single copy of
the current feed standards from
ORAHQOPIO@fda.hhs.gov. Please note
that due to editorial revisions and
public comments, the final standards
may differ from the copy you receive.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeping
Total hours
State Employee ....................................................................
40
1
40
3,000
120,000
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated to
3,000 hours per respondent. This
burden was determined by capturing the
average amount of time for each
respondent to assess the current state of
the program and work toward
implementation of each of the 11
standards contained in AFRPS. FDA
recognizes that full use and
implementation of the feed standards by
State feed programs will occur over
many years and the number of years to
fully implement the feed standards will
vary among States.
VerDate Sep<11>2014
17:18 Apr 11, 2016
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Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08331 Filed 4–11–16; 8:45 am]
Food and Drug Administration
[Docket Nos.: FDA–2014–E–2355; FDA–
2014–E–2356; and FDA–2014–E–2357]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination of Regulatory Review
Period for Purposes of Patent
Extension; GAZYVA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SUMMARY:
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12APN1
21580
Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
GAZYVA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human 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 June 13, 2016.
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
October 11, 2016. 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’’).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
17:18 Apr 11, 2016
Jkt 238001
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2014–E–2355; FDA–2014–E–2356; and
FDA–2014–E–2357 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
GAZYVA.’’
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.
PO 00000
Frm 00048
Fmt 4703
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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 GAZYVA
(obinutuzumab). GAZYVA is indicated,
in addition with chlorambucil, for the
treatment of patients with previously
untreated chronic lymphocytic
leukemia. Subsequent to this approval,
the U.S. Patent and Trademark Office
(USPTO) received patent term
restoration applications for GAZYVA
(U.S. Patent Nos. 6,602,684; 7,517,670;
and 8,021,856) from Genentech, Inc.,
and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated May 11, 2015, FDA
advised the USPTO that this human
biological product had undergone a
E:\FR\FM\12APN1.SGM
12APN1
Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
GAZYVA is 1,698 days. Of this time,
1,504 days occurred during the testing
phase of the regulatory review period,
while 194 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: March 11, 2009. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
March 11, 2009.
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): April 22, 2013. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
GAZYVA (BLA 125486) was initially
submitted on April 22, 2013.
3. The date the application was
approved: November 1, 2013. FDA has
verified the applicant’s claim that BLA
125486 was approved on November 1,
2013.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 929, 946, or 484
days, respectively, of patent term
extension.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
regulatory review period and that the
approval of GAZYVA represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
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
VerDate Sep<11>2014
17:18 Apr 11, 2016
Jkt 238001
[FR Doc. 2016–08338 Filed 4–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Global Affairs: Stakeholder
Listening Session in Preparation for
the 69th World Health Assembly
Time and date: May 6th, 2016, 10:30
a.m.–12:00 Noon EST.
Place: Hubert H. Humphrey Building,
Room 505A, 200 Independence Ave.
SW., Washington, District of Columbia
20201.
Status: Open, but requiring RSVP to
OGA.RSVP@hhs.gov.
Purpose: The U.S. Department of
Health and Human Services (HHS)—
charged with leading the U.S. delegation
to the 69th World Health Assembly—
will hold an informal Stakeholder
Listening Session on Friday, May 6,
10:30 a.m.–12:00 noon, in Conference
Room 505A of the Hubert H. Humphrey
Building, 200 Independence Ave. S.W.,
Washington, DC 20201.
The Stakeholder Listening Session
will help the HHS Office of Global
Affairs prepare the U.S. delegation for
the World Health Assembly by taking
full advantage of the knowledge, ideas,
feedback, and suggestions from all
communities interested in and affected
by agenda items to be discussed at the
69th World Health Assembly. Your
input will contribute to U.S. positions
as we negotiate with our international
colleagues at the World Health
Assembly these important health topics.
The listening session will be
organized by agenda item, and
participation is welcome from all
individuals, particularly members of
stakeholder communities, including:
• Public health and advocacy groups;
• State, local, and Tribal groups;
• Private industry;
• Minority health organizations; and
• Academic and scientific
organizations.
All agenda items to be discussed at
the 69th World Health Assembly can be
found at this Web site: https://
apps.who.int/gb/ebwha/pdf_files/
WHA69/A69_1-en.pdf.
RSVP: Due to security restrictions for
entry into the HHS Hubert H. Humphrey
PO 00000
Frm 00049
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21581
Building, we will need to receive RSVPs
for this event. Please send your full
name and organization to OGA.RSVP@
hhs.gov. If you are not a U.S. citizen,
please note this in the subject line of
your RSVP, and our office will contact
you to gain additional biographical
information for your clearance. Please
RSVP no later than Wednesday, April
27, 2016.
Written comments are welcome and
encouraged, even if you are planning on
attending in person. Please send these to
the email address: OGA.RSVP@hhs.gov.
We look forward to hearing your
comments relative to the 69th World
Health Assembly agenda items.
Dated: March 14, 2016.
Jimmy Kolker,
Assistant Secretary for Global Affairs.
[FR Doc. 2016–08287 Filed 4–11–16; 8:45 am]
BILLING CODE 4150–38–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Establishment of the
Secretary’s Advisory Committee on
National Health Promotion and Disease
Prevention Objectives for 2030 and
Solicitation of Nominations for
Membership; Correction
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, U.S. Department of Health
and Human Services.
ACTION: Notice; correction.
AGENCY:
The U.S. Department of
Health and Human Services published a
notice in the Federal Register, dated
March 17, 2016, to announce the
establishment of the Secretary’s
Advisory Committee on National Health
Promotion and Disease Prevention
Objectives for 2030 (Committee) and
invites nominations for membership.
This notice contained incorrect
information.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Emmeline Ochiai, email address:
HP2030@hhs.gov.
Correction
In the Federal Register, dated March
17, 2016, on page 14455, correct the
Title to read:
Announcement of Intent to Establish the
Secretary’s Advisory Committee on National
Health Promotion and Disease Prevention
Objectives for 2030 and Solicitation of
Nominations for Membership
and correct the SUMMARY to read:
SUMMARY: The U.S. Department of Health and
Human Services (HHS) announces its intent
E:\FR\FM\12APN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21579-21581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08338]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos.: FDA-2014-E-2355; FDA-2014-E-2356; and FDA-2014-E-2357]
Determination of Regulatory Review Period for Purposes of Patent
Extension; GAZYVA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for
[[Page 21580]]
GAZYVA and is publishing this notice of that determination as required
by law. FDA has made the determination because of the submission of
applications to the Director of the U.S. Patent and Trademark Office
(USPTO), Department of Commerce, for the extension of a patent which
claims that human 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 June
13, 2016. 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 October 11, 2016.
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, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2014-E-2355; FDA-2014-E-2356; and FDA-2014-E-2357 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; GAZYVA.''
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 GAZYVA
(obinutuzumab). GAZYVA is indicated, in addition with chlorambucil, for
the treatment of patients with previously untreated chronic lymphocytic
leukemia. Subsequent to this approval, the U.S. Patent and Trademark
Office (USPTO) received patent term restoration applications for GAZYVA
(U.S. Patent Nos. 6,602,684; 7,517,670; and 8,021,856) from Genentech,
Inc., and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated May
11, 2015, FDA advised the USPTO that this human biological product had
undergone a
[[Page 21581]]
regulatory review period and that the approval of GAZYVA 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
GAZYVA is 1,698 days. Of this time, 1,504 days occurred during the
testing phase of the regulatory review period, while 194 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: March 11,
2009. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on March 11,
2009.
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): April 22, 2013. FDA has verified the
applicant's claim that the biologics license application (BLA) for
GAZYVA (BLA 125486) was initially submitted on April 22, 2013.
3. The date the application was approved: November 1, 2013. FDA has
verified the applicant's claim that BLA 125486 was approved on November
1, 2013.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 929, 946, or 484 days, respectively, 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 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: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08338 Filed 4-11-16; 8:45 am]
BILLING CODE 4164-01-P
