Determination of Regulatory Review Period for Purposes of Patent Extension; LETAIRIS, 6635-6636 [E9-2683]
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6635
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
industry entitled ‘‘Updating Labeling for
Susceptibility Test Information in
Systemic Antibacterial Drug Products
and Antimicrobial Susceptibility
Testing Devices.’’ FDA is now in the
process of finalizing this guidance.
The Food and Drug Administration
Amendments Act of 2007 (FDAAA)
includes a requirement that FDA
identify and periodically update
susceptibility test interpretive criteria
for antibacterial drug products and
make those findings publicly available.
The guidance informs industry of how
FDA intends to comply with the
FDAAA requirement. Specifically, the
guidance describes procedures and
responsibilities for updating
information on susceptibility test
interpretive criteria, susceptibility test
methods, and quality control parameters
in the labeling for systemic antibacterial
drug products for human use. The
guidance also describes procedures for
making corresponding changes to
susceptibility test interpretive criteria
for antimicrobial susceptibility testing
devices.
Description of Respondents:
Respondents to this collection of
information are holders of new drug
applications and abbreviated new drug
applications.
Burden Estimate: Application holders
can use one of the following approaches
to meet their responsibilities to update
their product labeling under the
guidance and FDA regulations: (1)
Submit a labeling supplement that relies
upon a standard recognized by FDA in
a Federal Register notice or (2) submit
a labeling supplement that includes data
supporting a proposed change to the
microbiology information in the
labeling. In addition, application
holders should include in their annual
report an assessment of whether the
information in the Microbiology
subsection of their product labeling is
current or changes are needed. For
human drugs, this information
collection is already approved by OMB
under control number 0910–0572 (the
requirement in 21 CFR 201.56(a)(2) to
update labeling when new information
becomes available that causes the
labeling to become inaccurate, false, or
misleading) and OMB control number
0910–0001 (the requirement in 21 CFR
314.70(b)(2)(v) to submit labeling
supplements for certain changes in the
product’s labeling and the requirement
in 21 CFR 314.81(b)(2)(i) to include in
the annual report a brief summary of
significant new information from the
previous year that might affect the
labeling of the drug product).
In addition, under the guidance, if the
information in the applicant’s product
labeling differs from the standards
recognized by FDA in the Federal
Register notice, and the applicant
believes that changes to the labeling are
not needed, the applicant should
provide written justification to FDA
explainimg why the recognized
standard does not apply to its drug
product and why changes are not
needed to the Microbiology subsection
of the product’s labeling. This
justification should be submitted as
general correspondence to the product’s
application, and a statement indicating
that no change is currently needed and
the supporting justification should be
included in the annual report. Based on
our knowledge of the need to update
information on susceptibility test
interpretive criteria, susceptibility test
methods, and quality control parameters
in the labeling for systemic antibacterial
drug products for human use, we
estimate that, annually, only two
applicants will submit the written
justification described on the previous
sentences and in the guidance. FDA also
estimates that each justification will
take approximately 16 hours to prepare
and submit to FDA as general
correspondence and as part of the
annual report.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Justification submitted as general correspondence and in
the annual report
1There
ACTION:
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–E–0103, FDA–
2008–E–0110, FDA–2008–E–0113, and FDA–
2008–E–0114]
erowe on PROD1PC63 with NOTICES
Total
Responses
1
2
2
Hours per
Response
Total Hours
16
32
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–2682 Filed 2–9–09; 8:45 am]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LETAIRIS
AGENCY:
No. of
Responses
per Respondent
No. of
Respondents
Reporting Burden
Food and Drug Administration,
HHS.
VerDate Nov<24>2008
18:25 Feb 09, 2009
Jkt 217001
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LETAIRIS 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 written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\10FEN1.SGM
10FEN1
erowe on PROD1PC63 with NOTICES
6636
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
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 human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human 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 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 LETAIRIS
(ambrisentan). LETAIRIS is indicated
for the treatment of pulmonary arterial
hypertension (WHO Group 1) in
patients with WHO class II or III
symptoms to improve exercise capacity
and delay clinical worsening.
Subsequent to this approval, the Patent
and Trademark Office received four
patent term restoration applications for
LETAIRIS (U.S. Patent Nos. 5,703,017;
5,840,722; 5,932,730; and 7,109,205)
from Abbott Gmbh & Co., KG, and the
Patent and Trademark Office requested
FDA’s assistance in determining these
patents’ eligibility for patent term
restoration. In a letter dated April 22,
2008, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
LETAIRIS represented the first
permitted commercial marketing or use
of the product. Shortly 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
LETAIRIS is 1,871 days. Of this time,
1,691 days occurred during the testing
phase of the regulatory review period,
while 180 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 act) (21 U.S.C.
355(i)) became effective: May 3, 2002.
The applicant claims July 4, 2002, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
IND effective date was May 3, 2002, the
date a previous IND was removed from
full clinical hold.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 18, 2006.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
LETAIRIS (NDA 22–081) was initially
submitted on December 18, 2006.
3. The date the application was
approved: June 15, 2007. FDA has
verified the applicant’s claim that NDA
22–081 was approved on June 15, 2007.
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 995 days of patent
term extension for U.S. Patent Nos.
5,703,017; 5,840,722; and 5,932,730,
and 225 days of patent term extension
for U.S. Patent No. 7,109,205.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by April 13, 2009.
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
August 10, 2009. 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.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–2683 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–E–0423] (formerly
Docket No. 2005E–0255)
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LUNESTA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LUNESTA 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 Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
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 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 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 human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6635-6636]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2683]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-E-0103, FDA-2008-E-0110, FDA-2008-E-0113, and
FDA-2008-E-0114]
Determination of Regulatory Review Period for Purposes of Patent
Extension; LETAIRIS
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for LETAIRIS 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 written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov.
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 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 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.
[[Page 6636]]
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 human drug product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human 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 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 LETAIRIS
(ambrisentan). LETAIRIS is indicated for the treatment of pulmonary
arterial hypertension (WHO Group 1) in patients with WHO class II or
III symptoms to improve exercise capacity and delay clinical worsening.
Subsequent to this approval, the Patent and Trademark Office received
four patent term restoration applications for LETAIRIS (U.S. Patent
Nos. 5,703,017; 5,840,722; 5,932,730; and 7,109,205) from Abbott Gmbh &
Co., KG, and the Patent and Trademark Office requested FDA's assistance
in determining these patents' eligibility for patent term restoration.
In a letter dated April 22, 2008, FDA advised the Patent and Trademark
Office that this human drug product had undergone a regulatory review
period and that the approval of LETAIRIS represented the first
permitted commercial marketing or use of the product. Shortly
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
LETAIRIS is 1,871 days. Of this time, 1,691 days occurred during the
testing phase of the regulatory review period, while 180 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 act) (21 U.S.C. 355(i)) became effective:
May 3, 2002. The applicant claims July 4, 2002, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was May 3, 2002, the
date a previous IND was removed from full clinical hold.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: December 18,
2006. FDA has verified the applicant's claim that the new drug
application (NDA) for LETAIRIS (NDA 22-081) was initially submitted on
December 18, 2006.
3. The date the application was approved: June 15, 2007. FDA has
verified the applicant's claim that NDA 22-081 was approved on June 15,
2007.
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 995 days of
patent term extension for U.S. Patent Nos. 5,703,017; 5,840,722; and
5,932,730, and 225 days of patent term extension for U.S. Patent No.
7,109,205.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by April 13, 2009. 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 August 10,
2009. 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.
Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 2, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-2683 Filed 2-9-09; 8:45 am]
BILLING CODE 4160-01-S
