Determination of Regulatory Review Period for Purposes of Patent Extension; RAPAFLO, 37715-37716 [E9-18032]
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37715
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices
with a protocol is required to be
submitted at 90-day intervals. In
addition, samples, which must be
accompanied by a protocol, may at any
time be required to be submitted to
CBER if continued evaluation is deemed
necessary.
Samples and protocols are required by
FDA to help ensure the safety, purity, or
potency of a product because of the
potential lot-to-lot variability of a
product produced from living
organisms. In cases of certain biological
products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological
products) that are known to have lot-tolot consistency, official lot release is not
normally required. However,
submissions of samples and protocols of
these products may still be required for
surveillance, licensing, and export
purposes, or in the event that FDA
obtains information that the
manufacturing process may not result in
consistent quality of the product.
The following burden estimate is for
the protocols required to be submitted
with each sample. The collection of
samples is not a collection of
information under 5 CFR 1320.3(h)(2).
Respondents to the collection of
information under § 610.2 are
manufacturers of licensed biological
products. Respondents to the collection
of information under §§ 660.6(b),
660.36(a)(2) and (b), and 660.46(b) are
manufacturers of the specific products
referenced previously in this document.
The estimated number of respondents
for each regulation is based on the
annual number of manufacturers that
submitted samples and protocols for
biological products including
submissions for lot release, surveillance,
licensing, or export. Based on
information obtained from FDA’s
database system, approximately 69
manufacturers submitted samples and
protocols in fiscal year (FY) 2008, under
the regulations cited previously in this
document. FDA estimates that
approximately 65 manufacturers
submitted protocols under § 610.2 and
21 CFR 610.3 manufacturers submitted
protocols under the regulations
(§§ 660.6 and 660.46) for the other
specific products. FDA received no
submissions under § 660.36; however,
FDA is using the estimate of one
protocol submission in the event one is
submitted in the future.
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2008, which totaled
6,314, for the various submission
requirements of samples and protocols
for the licensed biological products. The
rate of final actions is not expected to
change significantly in the next few
years. The hours per response are based
on information provided by industry.
The burden estimates provided by
industry ranged from 1 to 5.5 hours.
Under § 610.2, the hours per response
are based on the average of these
estimates and rounded to 3 hours.
Under the remaining regulations, the
hours per response are based on the
higher end of the estimate (rounded to
5 or 6 hours) since more information is
generally required to be submitted in
the other protocols than under § 610.2.
In the Federal Register of March 6,
2009 (74 FR 9820), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
610.2
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
65
95.5
6,208
3
18,624
660.6(b)
2
44
88
5
440
660.36(a)(2) and (b)
1
1
1
6
6
660.46(b)
1
17
17
5
85
Total
69
1 There
Dated: July 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–17978 Filed 7–28–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
[Docket No. FDA–2009–E–0072]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RAPAFLO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
6,314
19,155
are no capital costs or operating and maintenance costs associated with this collection of information.
Notice.
VerDate Nov<24>2008
18:30 Jul 28, 2009
Jkt 217001
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
RAPAFLO 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,
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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\29JYN1.SGM
29JYN1
mstockstill on DSKH9S0YB1PROD with NOTICES
37716
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 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 drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of 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 RAPAFLO
(silodosin). RAPAFLO is indicated for
treatment of the signs and symptoms of
benign prostatic hyperplasia.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
RAPAFLO (U.S. Patent No. 5,387,603)
from Kissei Pharmaceutical Co., Ltd.,
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 26, 2009, FDA advised the
Patent and Trademark Office that this
human drug product had undergone a
regulatory review period and that the
approval of RAPAFLO 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
RAPAFLO is 3,681 days. Of this time,
3,380 days occurred during the testing
phase of the regulatory review period,
while 301 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: September 12,
1998. The applicant claims September
17, 1998, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
September 12, 1998, which was 30 days
after FDA receipt of the IND.
VerDate Nov<24>2008
18:30 Jul 28, 2009
Jkt 217001
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: December 13, 2007.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
RAPAFLO (NDA 22–206) was initially
submitted on December 13, 2007.
3. The date the application was
approved: October 8, 2008. FDA has
verified the applicant’s claim that NDA
22–206 was approved on October 8,
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) written or
electronic comments and ask for a
redetermination by September 28, 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
January 25, 2010. 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: June 23, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–18032 Filed 7–28–09; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0021]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; DUREZOL
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
DUREZOL 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 drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Notices]
[Pages 37715-37716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18032]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0072]
Determination of Regulatory Review Period for Purposes of Patent
Extension; RAPAFLO
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for RAPAFLO 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.
[[Page 37716]]
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of 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 RAPAFLO
(silodosin). RAPAFLO is indicated for treatment of the signs and
symptoms of benign prostatic hyperplasia. Subsequent to this approval,
the Patent and Trademark Office received a patent term restoration
application for RAPAFLO (U.S. Patent No. 5,387,603) from Kissei
Pharmaceutical Co., Ltd., 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 26, 2009, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of RAPAFLO 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
RAPAFLO is 3,681 days. Of this time, 3,380 days occurred during the
testing phase of the regulatory review period, while 301 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:
September 12, 1998. The applicant claims September 17, 1998, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was September
12, 1998, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: December 13,
2007. FDA has verified the applicant's claim that the new drug
application (NDA) for RAPAFLO (NDA 22-206) was initially submitted on
December 13, 2007.
3. The date the application was approved: October 8, 2008. FDA has
verified the applicant's claim that NDA 22-206 was approved on October
8, 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) written or electronic comments and ask for a redetermination
by September 28, 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 January
25, 2010. 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: June 23, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-18032 Filed 7-28-09; 8:45 am]
BILLING CODE 4160-01-S
