Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA, 39587-39589 [2017-17566]
Download as PDF
<![CDATA[
39587
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices
structure in order to (1) improve the
measurement of covered health topics,
(2) reduce respondent burden by
shortening the length of the
questionnaire and seamlessly
integrating supplements, (3) harmonize
overlapping content with other federal
health surveys, (4) establish a long-term
structure of ongoing and periodic topics,
in short, Web-based methodological and
cognitive testing activities to evaluate
the redesigned questionnaire and/or
inform the development of new rotating
and supplemental content using Web
and/or mail survey tools.
There is no cost to the respondents
other than their time. Clearance is
sought for three years, to collect data for
2018–2020.
and (5) incorporate advances in survey
methodology and measurement.
As in past years, and in accordance
with the 1995 initiative to increase the
integration of surveys within the DHHS,
respondents to the 2018 NHIS will serve
as the sampling frame for the Medical
Expenditure Panel Survey. In addition,
a subsample of NHIS respondents and/
or members of commercial survey
panels may be identified to participate
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Adult Household Member .................
39,375
1
23/60
15,094
Sample Adult .....................................
Adult Family Member ........................
Adult Family Member ........................
Adult Household Member .................
Sample Adult .....................................
Adult Family Member ........................
Adult Family Member ........................
Adult Family Member ........................
Main Household Composition and
Family Core.
Main Adult Core ...............................
Main Child Core ...............................
Main Supplements ...........................
Redesigned Family Core .................
Redesigned Adult Core ....................
Redesigned Child Core ....................
Methodological Projects ...................
Reinterview Survey ..........................
31,500
12,250
45,000
5,625
4,500
1,750
15,000
5,000
1
1
1
1
1
1
1
1
15/60
10/60
20/60
23/60
15/60
10/60
20/60
5/60
7,875
2,042
15,000
2,156
1,125
292
5,000
417
Total ...........................................
...........................................................
........................
........................
........................
49,000
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–17582 Filed 8–18–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–E–0264; FDA–
2013–E–0263; and FDA–2013–E–0218]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RECUVYRA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for RECUVYRA 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 animal drug
product.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:37 Aug 18, 2017
Jkt 241001
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 October 20, 2017.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 20, 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 October 20,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 20, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
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,
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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
E:\FR\FM\21AUN1.SGM
21AUN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
39588
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2013–E–0264; FDA–2013–E–0263; and
FDA–2013–E–0218 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
RECUVYRA.’’ 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 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,
VerDate Sep<11>2014
18:37 Aug 18, 2017
Jkt 241001
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For animal drug
products, the testing phase begins on
the earlier date when either a major
environmental effects test was initiated
for the drug or when an exemption
under section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360b(j)) became effective and
runs until the approval phase begins.
The approval phase starts with the
initial submission of an application to
market the animal 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 an animal
drug product will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(4)(B).
FDA has approved for marketing the
animal drug product RECUVYRA
(fentanyl). RECUVYRA is indicated for
the control of postoperative pain
associated with surgical procedures in
dogs. Subsequent to this approval, the
USPTO received patent term restoration
applications for RECUVYRA (U.S.
Patent Nos. 6,299,900; 6,818,226; and
6,916,486) from Acrux DDS Pty. Ltd.,
and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated April 26, 2016, FDA
advised the USPTO that this animal
drug product had undergone a
regulatory review period and that the
approval of RECUVYRA represented the
first permitted commercial marketing or
use of the product. Thereafter, the
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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
RECUVYRA is 2,092 days. Of this time,
2,037 days occurred during the testing
phase of the regulatory review period,
while 55 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 FD&C Act (21
U.S.C. 355(i)) became effective: October
3, 2006. The applicant claims August
31, 2005, as the date the investigational
new animal drug application (INAD)
became effective. However, FDA records
indicate that the INAD effective date
was October 3, 2006, which was the
date a major health or environmental
effects test began.
2. The date the application was
initially submitted with respect to the
animal drug product under section 512
of the FD&C Act (21 U.S.C. 360b): April
30, 2012. The applicant claims April 18,
2012, as the date the new animal drug
application (NADA) for RECUVYRA
(NADA 141–337) was initially
submitted. However, FDA records
indicate that NADA 141–337 was
submitted on April 30, 2012.
3. The date the application was
approved: June 23, 2012. FDA has
verified the applicant’s claim that
NADA 141–337 was approved on June
23, 2012.
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 1,279 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 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 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.
E:\FR\FM\21AUN1.SGM
21AUN1
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices
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: August 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17566 Filed 8–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2363]
Electronic Study Data Submission;
Data Standards; Support for Standard
for Exchange of Nonclinical Data
Implementation Guide Version 3.1
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is announcing support for the
3.1 version of Clinical Data Interchange
Standards Consortium (CDISC) Standard
for Exchange of Nonclinical Data (SEND
IG 3.1), the end of support for the 3.0
version of SEND IG, and an update to
the FDA Data Standards Catalog
(Catalog). (See https://www.fda.gov/
forindustry/datastandards/
studydatastandards/default.htm.) SEND
IG 3.1 has been available from CDISC
(www.cdisc.org) since July 2016. FDA is
encouraging sponsors and applicants to
use SEND IG 3.1 in investigational study
data provided in regulatory submissions
to CDER.
FOR FURTHER INFORMATION CONTACT: Ron
Fitzmartin, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1115, Silver Spring,
MD 20993–0002, 301–796–5333, email:
CDERDataStandards@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
I. Background
On December 17, 2014, FDA
published final guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Standardized Study Data’’ (eStudy
Data), posted on FDA’s Study Data
Standards Resources Web page at
https://www.fda.gov/forindustry/
datastandards/studydatastandards/
VerDate Sep<11>2014
18:37 Aug 18, 2017
Jkt 241001
default.htm. The eStudy Data guidance
implements the electronic submission
requirements of section 745A(a) of the
Food, Drug and Cosmetic Act (21 U.S.C.
379k–1(a)) for study data contained in
new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), biologics license applications
(BLAs), and investigational new drug
applications (INDs) to FDA’s Center for
Biologics Evaluation and Research or
CDER by specifying the format for
electronic submissions. The initial
timetable for implementing electronic
submission requirements for study data
was December 17, 2016 (24 months after
issuance of final guidance for NDAs,
BLAs, ANDAs, and 36 months for INDs).
The eStudy Data guidance states that a
Federal Register notice will specify the
transition date for all version updates
(with the month and day for the
transition date corresponding to March
15).
The transition date for support of
version 3.1 of CDISC SEND IG is March
15, 2018. Although SEND IG version 3.1
is supported as of this Federal Register
notice and sponsors or applicants are
encouraged to begin using it, the new
version will only be required in
submissions for studies that start after
March 15, 2019. The Catalog will list
March 15, 2019, as the ‘‘date
requirement begins.’’ When multiple
versions of an FDA-supported standard
are listed in the Catalog, sponsors or
applicants can select a version to use.
The transition date for the end of FDA
support for SEND IG 3.0 is March 15,
2018. Therefore, FDA support for SEND
IG 3.0 will end for studies that start after
March 15, 2019. The Catalog will be
updated to list March 15, 2019, as the
‘‘date support ends.’’
II. Electronic Access
Persons with access to the Internet
may obtain the referenced material at
https://www.fda.gov/ectd.
Dated: August 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17567 Filed 8–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–1956]
Identifying Trading Partners Under the
Drug Supply Chain Security Act; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
ACTION:
39589
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Identifying Trading Partners Under the
Drug Supply Chain Security Act’’ (draft
trading partner guidance). FDA is
issuing this guidance to assist industry
and State and local governments in
understanding how to categorize the
entities in the drug supply chain in
accordance with the Drug Supply Chain
Security Act (DSCSA). This guidance
explains how to determine when certain
statutory requirements will apply to
entities that may be considered trading
partners in the drug supply chain. FDA
is also soliciting public input specific to
the activities of ‘‘private-label
distributors’’ of drug products and
whether those activities fall within the
definitions under DSCSA of the various
trading partners.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 20,
2017.
SUMMARY:
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’’).
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Pages 39587-39589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17566]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-E-0264; FDA-2013-E-0263; and FDA-2013-E-0218]
Determination of Regulatory Review Period for Purposes of Patent
Extension; RECUVYRA
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 RECUVYRA 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 animal 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 October
20, 2017. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by February 20, 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 October 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 20, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): 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
[[Page 39588]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2013-E-0264; FDA-2013-E-0263; and FDA-2013-E-0218 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; RECUVYRA.'' 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 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 animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the animal 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 an animal
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
FDA has approved for marketing the animal drug product RECUVYRA
(fentanyl). RECUVYRA is indicated for the control of postoperative pain
associated with surgical procedures in dogs. Subsequent to this
approval, the USPTO received patent term restoration applications for
RECUVYRA (U.S. Patent Nos. 6,299,900; 6,818,226; and 6,916,486) from
Acrux DDS Pty. Ltd., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated April 26, 2016, FDA advised the USPTO that this animal
drug product had undergone a regulatory review period and that the
approval of RECUVYRA 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
RECUVYRA is 2,092 days. Of this time, 2,037 days occurred during the
testing phase of the regulatory review period, while 55 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 FD&C Act (21
U.S.C. 355(i)) became effective: October 3, 2006. The applicant claims
August 31, 2005, as the date the investigational new animal drug
application (INAD) became effective. However, FDA records indicate that
the INAD effective date was October 3, 2006, which was the date a major
health or environmental effects test began.
2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the FD&C Act (21 U.S.C.
360b): April 30, 2012. The applicant claims April 18, 2012, as the date
the new animal drug application (NADA) for RECUVYRA (NADA 141-337) was
initially submitted. However, FDA records indicate that NADA 141-337
was submitted on April 30, 2012.
3. The date the application was approved: June 23, 2012. FDA has
verified the applicant's claim that NADA 141-337 was approved on June
23, 2012.
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 1,279 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 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 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.
[[Page 39589]]
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: August 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17566 Filed 8-18-17; 8:45 am]
BILLING CODE 4164-01-P
