Determination of Regulatory Review Period for Purposes of Patent Extension; SAMSCA, 77879-77880 [2010-31298]
Download as PDF
<![CDATA[
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices
FDA recently approved for marketing
the medical device, FREESTYLE
NAVIGATOR. FREESTYLE
NAVIGATOR is indicated for
continually recording interstitial fluid
glucose levels in people (ages 18 and
older) with diabetes mellitus for the
purpose of improving diabetes
management. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for FREESTYLE
NAVIGATOR (U.S. Patent No.
5,262,035) from Abbott Diabetes Care
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
February 17, 2010, FDA advised the
Patent and Trademark Office that this
medical device had undergone a
regulatory review period and that the
approval of FREESTYLE NAVIGATOR
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that the
FDA determine the product’s regulatory
review period. FDA has determined that
the applicable regulatory review period
for FREESTYLE NAVIGATOR is 2,320
days. Of this time, 750 days occurred
during the testing phase of the
regulatory review period, while 1,570
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date clinical investigation on
humans is begun as approved by an
institutional review board (IRB) under
section 520(g)(3) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and
when no investigational device
exemption (IDE) is required: November
6, 2001. The applicant claims that
investigation of the device qualified for
a non-significant risk study for the
purpose of establishing clinical data
necessary to support a subsequent
premarket approval under section 515 of
the FD&C Act. FDA has verified the
applicant’s claim that the device did not
require an IDE under section 520(g) of
the FD&C act, but did require IRB
approval, granted November 6, 2001, for
human tests to begin. This date
represents the beginning of the testing
phase of the regulatory review period.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): November 25,
2003. The applicant claims November
24, 2003, as the date the first premarket
approval application (PMA) for
FREESTYLE NAVIGATOR (PMA
P030048) was initially submitted.
However, FDA records indicate that
VerDate Mar<15>2010
17:09 Dec 13, 2010
Jkt 223001
PMA P030048 was submitted on
November 25, 2003.
3. The date the application was
approved: March 12, 2008. FDA has
verified the applicant’s claim that PMA
P050020 was approved on March 12,
2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,826 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by February 14,
2011. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by June 13, 2011. To meet its
burden, the petition must 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–31240 Filed 12–13–10; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
77879
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2010–E–0037 and FDA–
2010–E–0038]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SAMSCA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SAMSCA 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 Patents
and Trademarks, Department of
Commerce, for the extension of patents
which claim that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 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. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: 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.
SUMMARY:
E:\FR\FM\14DEN1.SGM
14DEN1
srobinson on DSKHWCL6B1PROD with NOTICES
77880
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks 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 recently approved for marketing
the human drug product SAMSCA
(tolvaptan). SAMSCA is indicated for
the treatment of clinically significant
hypervolemic and euvolemic
hyponatremia, including patients with
heart failure, cirrhosis, and Syndrome of
Inappropriate Antidiuretic Hormone.
Subsequent to this approval, the Patent
and Trademark Office received patent
term restoration applications for
SAMSCA (U.S. Patent Nos. 5,258,510
and 5,753,677) from Otsuka
Pharmaceutical Co., Ltd., and the Patent
and Trademark Office requested FDA’s
assistance in determining these patents’
eligibility for patent term restoration. In
a letter dated March 3, 2010, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of SAMSCA
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
SAMSCA is 4,722 days. Of this time,
4,147 days occurred during the testing
phase of the regulatory review period,
while 575 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: June 16,
1996. The applicant claims October 23,
1997, as the date the investigational new
drug application (IND) became effective.
However, according to FDA records, this
IND was not the first IND received for
this active ingredient. In general, FDA
has used the first IND of the active
ingredient of the drug product as the
beginning of the testing phase, if
information derived from this first IND
was or could have been relied on or was
relevant for approval to market the drug
product. FDA records indicate that the
effective date of the first IND for
tolvaptan was June 16, 1996, which was
VerDate Mar<15>2010
17:09 Dec 13, 2010
Jkt 223001
30 days after FDA receipt of this first
IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: October 23,
2007. FDA has verified the applicant’s
claim that the new drug application
(NDA) for SAMSCA (NDA 22–275) was
submitted on October 23, 2007.
3. The date the application was
approved: May 19, 2009. FDA has
verified the applicant’s claim that NDA
22–275 was approved on May 19, 2009.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,826 days or 1,827
days respectively of patent term
extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by February 14,
2011. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by June 13, 2011. To meet its
burden, the petition must 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–31298 Filed 12–13–10; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; GuLF Worker Study: Gulf
Long-Term Follow-Up Study for Oil
Spill Clean-Up Workers and Volunteers
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Environmental Health
Sciences (NIEHS), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on 7 October 2010
on pages 62132–3 and allowed 60-days
for public comment. One public
comment was received and addressed
regarding the appropriateness and
sources for funding the survey. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
5 CFR 1320.5: Reporting and
Recordkeeping Requirements: Final
Rule: Respondents to this collection of
information are not required to respond
unless the data collection instruments
display a currently valid OMB control
number.
SUMMARY:
Proposed Collection
Title: GuLF Worker Study: Gulf LongTerm Follow-Up Study for Oil Spill
Clean-Up Workers and Volunteers. Type
of Information Collection Request: New.
Need and Use of Information Collection:
The purpose of the GuLF Study is to
investigate potential short- and longterm health effects associated with oil
spill clean-up activities and exposures
surrounding the Deepwater Horizon
disaster; and to create a resource for
additional collaborative research on
focused hypotheses or subgroups. Over
55,000 persons participating in oil-spill
clean-up activities have been exposed to
a range of known and suspected toxins
in crude oil, burning oil, and
dispersants, to excessive heat, and
possibly to stress due to widespread
economic and lifestyle disruption.
Exposures range from negligible to
potentially significant, however,
potential long-term human health
E:\FR\FM\14DEN1.SGM
14DEN1
]]>Agencies
[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77879-77880]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31298]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-E-0037 and FDA-2010-E-0038]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SAMSCA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SAMSCA 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 Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human drug product.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 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. 6222, Silver Spring, MD 20993-0002, 301-796-3602.
SUPPLEMENTARY INFORMATION: 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.
[[Page 77880]]
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks 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 recently approved for marketing the human drug product SAMSCA
(tolvaptan). SAMSCA is indicated for the treatment of clinically
significant hypervolemic and euvolemic hyponatremia, including patients
with heart failure, cirrhosis, and Syndrome of Inappropriate
Antidiuretic Hormone. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
SAMSCA (U.S. Patent Nos. 5,258,510 and 5,753,677) from Otsuka
Pharmaceutical Co., Ltd., and the Patent and Trademark Office requested
FDA's assistance in determining these patents' eligibility for patent
term restoration. In a letter dated March 3, 2010, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of SAMSCA represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
SAMSCA is 4,722 days. Of this time, 4,147 days occurred during the
testing phase of the regulatory review period, while 575 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: June 16, 1996. The applicant claims October 23, 1997, as the
date the investigational new drug application (IND) became effective.
However, according to FDA records, this IND was not the first IND
received for this active ingredient. In general, FDA has used the first
IND of the active ingredient of the drug product as the beginning of
the testing phase, if information derived from this first IND was or
could have been relied on or was relevant for approval to market the
drug product. FDA records indicate that the effective date of the first
IND for tolvaptan was June 16, 1996, which was 30 days after FDA
receipt of this first IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October
23, 2007. FDA has verified the applicant's claim that the new drug
application (NDA) for SAMSCA (NDA 22-275) was submitted on October 23,
2007.
3. The date the application was approved: May 19, 2009. FDA has
verified the applicant's claim that NDA 22-275 was approved on May 19,
2009.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,826 days or
1,827 days respectively of patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 14, 2011. Furthermore, any interested
person may petition FDA for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period by June 13, 2011. To meet its burden, the petition must
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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31298 Filed 12-13-10; 8:45 am]
BILLING CODE 4160-01-P
