Determination of Regulatory Review Period for Purposes of Patent Extension; LUCENTIS, 30949-30950 [E8-12007]
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Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices
are entered into the system for a period
of 20 years. Records are housed in both
active and archival files. All claimsrelated records are encompassed by the
document preservation order and will
be retained until notification is received
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a person with Medicare could be
identified because the sample is small
enough to identify participants. CMS
would make exceptions if the
information is needed for one of the
routine uses or if it’s required by law.
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cartridges (magnetic storage media) and
in a DB2 relational database
management environment (DASD data
storage media).
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Information is most frequently
retrieved by HICN, provider number
(facility, physician, IDs), service dates,
and beneficiary state code.
jlentini on PROD1PC65 with NOTICES
Jkt 214001
[Docket Nos. FDA–2007–E–0461 (formerly
Docket No. 2007E–0424), FDA–2007–E–0165
(formerly Docket No. 2007E–0425), FDA–
2007–E–0459 (formerly Docket No. 2007E–
0146)]
NOTIFICATION PROCEDURE:
HHS.
For purpose of notification, the
subject individual should write to the
system manager who will require the
system name, and the retrieval selection
criteria (e.g., HICN, facility/pharmacy
number, service dates, etc.).
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR 5b.5
(a)(2).)
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
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information to be provided by the
TROOP Facilitator.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. E8–11949 Filed 5–28–08; 8:45 am]
BILLING CODE 4120–03–P
Records are maintained with
identifiers for all transactions after they
17:45 May 28, 2008
Food and Drug Administration
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LUCENTIS
RETENTION AND DISPOSAL:
VerDate Aug<31>2005
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Director, Centers for Beneficiary
Choices, CMS, Mail stop C5–19–07,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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and the corresponding implementing
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policies and standards include but are
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publications, the HHS Information
Systems Program Handbook, and the
CMS Information Security Handbook.
30949
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
LUCENTIS 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 biological
product.
Submit written or electronic
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, Center for Drug
Evaluation and Research, 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
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
ADDRESSES:
E:\FR\FM\29MYN1.SGM
29MYN1
jlentini on PROD1PC65 with NOTICES
30950
Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of 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 biological 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 biologic product LUCENTIS
(ranibizumab). LUCENTIS is indicated
for the treatment of patients with
neovascular (wet) age-related macular
degeneration. Subsequent to this
approval, the Patent and Trademark
Office received patent term restoration
applications for LUCENTIS (U.S. Patent
Nos. 6,407,213; 6,884,879; and
7,060,269) from Genentech, Inc., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In letters dated July 24,
2007, and November 21, 2007, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
LUCENTIS 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
LUCENTIS is 2,430 days. Of this time,
2,247 days occurred during the testing
phase of the regulatory review period,
while 183 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: November 6, 1999.
The applicant claims October 7, 1999, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was November 6,
1999, which was 30 days after FDA
receipt of the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
VerDate Aug<31>2005
17:45 May 28, 2008
Jkt 214001
U.S.C. 262): December 30, 2005. The
applicant claims December 29, 2005, as
the date the biologics license
application (BLA) for LUCENTIS (BLA
125156/0) was initially submitted.
However, FDA records indicate that
BLA 125156/0 was submitted on
December 30, 2005.
3. The date the application was
approved: June 30, 2006. FDA has
verified the applicant’s claim that BLA
125156/0 was approved on June 30,
2006.
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
for U.S. Patent Nos. 6,407,213;
6,884,879; and 7,060,269, this applicant
seeks 378 days; 307 days or 17 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) written or
electronic comments and ask for a
redetermination by July 28, 2008.
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
November 25, 2008. 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.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Dated: May 8, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–12007 Filed 5–28–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–M–0467] (formerly
Docket No. 2007M–0408), [Docket No. FDA–
2007–M–0481] (formerly Docket No. 2007M–
0467), [Docket No. FDA–2007–M–0480]
(formerly Docket No. 2007M–0409), [Docket
No. FDA–2007–M–0472] (formerly Docket
No. 2007M–0413), [Docket No. FDA–2007–
M–0468] (formerly Docket No. 2007M–0446),
[Docket No. FDA–2007–M–0494] (formerly
Docket No. 2007M–0380), [Docket No. FDA–
2007–M–0493] (formerly Docket No. 2007M–
0411), [Docket No. FDA–2007–M–0492]
(formerly Docket No. 2007M–0410), [Docket
No. FDA–2007–M–0490] (formerly Docket
No. 2007M–0415), [Docket No. FDA–2007–
M–0491] (formerly Docket No. 2007M–0447]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
agency’s Division of Dockets
Management.
Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in Table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Samie Allen, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4013.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29MYN1.SGM
29MYN1
]]>Agencies
[Federal Register Volume 73, Number 104 (Thursday, May 29, 2008)]
[Notices]
[Pages 30949-30950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12007]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2007-E-0461 (formerly Docket No. 2007E-0424), FDA-
2007-E-0165 (formerly Docket No. 2007E-0425), FDA-2007-E-0459 (formerly
Docket No. 2007E-0146)]
Determination of Regulatory Review Period for Purposes of Patent
Extension; LUCENTIS
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for LUCENTIS 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 biological product.
ADDRESSES: Submit written or electronic 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, Center for Drug
Evaluation and Research, 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective
[[Page 30950]]
and runs until the approval phase begins. The approval phase starts
with the initial submission of an application to market the human
biological product and continues until FDA grants permission to market
the biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of 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 biological 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 biologic product
LUCENTIS (ranibizumab). LUCENTIS is indicated for the treatment of
patients with neovascular (wet) age-related macular degeneration.
Subsequent to this approval, the Patent and Trademark Office received
patent term restoration applications for LUCENTIS (U.S. Patent Nos.
6,407,213; 6,884,879; and 7,060,269) from Genentech, Inc., and the
Patent and Trademark Office requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In letters dated
July 24, 2007, and November 21, 2007, FDA advised the Patent and
Trademark Office that this human biological product had undergone a
regulatory review period and that the approval of LUCENTIS 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
LUCENTIS is 2,430 days. Of this time, 2,247 days occurred during the
testing phase of the regulatory review period, while 183 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: November 6,
1999. The applicant claims October 7, 1999, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was November 6, 1999,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 30, 2005. The applicant claims
December 29, 2005, as the date the biologics license application (BLA)
for LUCENTIS (BLA 125156/0) was initially submitted. However, FDA
records indicate that BLA 125156/0 was submitted on December 30, 2005.
3. The date the application was approved: June 30, 2006. FDA has
verified the applicant's claim that BLA 125156/0 was approved on June
30, 2006.
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 for U.S. Patent Nos. 6,407,213;
6,884,879; and 7,060,269, this applicant seeks 378 days; 307 days or 17
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) written or electronic comments and ask for a redetermination
by July 28, 2008. 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 November 25,
2008. 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: May 8, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-12007 Filed 5-28-08; 8:45 am]
BILLING CODE 4160-01-S
