Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 30950-30951 [E8-12012]
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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
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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.
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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:
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30951
Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from October 1, 2007, through
December 31, 2007. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2007, THROUGH DECEMBER 31, 2007.
PMA No./Docket No.
Applicant
TRADE NAME
Approval Date
P000009 (S4)/2007M–
0408
Biotronik, Inc.
TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER
DEFIBRILLATOR ICD SYSTEM
September 9, 2002
P060031/2007M–0467
Bio-Rad Laboratories
BIO–RAD MONOLISA ANTI–HBC EIA
April 27, 2007
P060005/2007M–0409
Siemens Medical Solutions Diagnostics
IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA
ASSAYS
May 11, 2007
P060017/2007M–0413
Veridex, LLC
GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
July 16, 2007
P040040/2007M–0446
AGA Medical Corp.
AMPLATZER MUSCULAR VSD
September 7, 2007
P070009/2007M–0380
Obtech Medical GMBH
REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200–X
September 28, 2007
P070012/2007M–0411
Medtronic Vascular
EXPONENT SELF-EXPANDING CAROTIC STENT SYSTEM
WITH OVER THE WIRE OR RAPID EXHANGE DELIVERY
SYSTEM
October 23, 2007
P060038/2007M–0410
Carbomedics, Inc.
MITROFLOW AORTIC PERICARDIAL HEART VALVE
October 23, 2007
H990002/2007M–0415
Genzyme Biosurgery
EPICEL (CULTURED EPIDERMAL AUTOGRAFTS)
October 25, 2007
P060035/2007M–0447
Abbott Laboratories
ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
November 6, 2007
II. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
National Institutes of Health
Dated: May 16, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E8–12012 Filed 5–28–08; 8:45 am]
jlentini on PROD1PC65 with NOTICES
BILLING CODE 4160–01–S
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17:45 May 28, 2008
Proposed Collection; Comment
Request; The Prevalence and
Incidence of HIV Molecular Variants
and Their Correlation With Risk
Behaviors and HIV Treatment in
Brazilian Blood Donors
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
Jkt 214001
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projects to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: The
Prevalence and Incidence of HIV
Molecular Variants and Their
Correlation With Risk Behaviors and
HIV Treatment in Brazilian Blood
Donors. Type of Information Collection
Request: NEW. Need and Use of
Information Collection: Establishing and
monitoring viral prevalence and
incidence rates, and identifying risk
behaviors for HIV incidence among
blood donors, are critical to assessing
and reducing risk of HIV transmission
through blood transfusion. Identifying
donation samples from donors with
recent HIV infection is particularly
critical as it enables characterization of
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[Federal Register Volume 73, Number 104 (Thursday, May 29, 2008)]
[Notices]
[Pages 30950-30951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12012]
-----------------------------------------------------------------------
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.
ADDRESSES: 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.
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:
[[Page 30951]]
I. Background
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at https://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the act. The 30-day
period for requesting reconsideration of an FDA action under Sec.
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA
begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from October 1, 2007, through December 31,
2007. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.
Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From October 1, 2007, through December 31, 2007.
------------------------------------------------------------------------
PMA No./Docket Approval
No. Applicant TRADE NAME Date
------------------------------------------------------------------------
P000009 (S4)/ Biotronik, TACHOS DR ATRIAL TX September
2007M-0408 Inc. IMPLANTABLE CARDIOVERTER 9, 2002
DEFIBRILLATOR ICD SYSTEM
------------------------------------------------------------------------
P060031/2007M- Bio-Rad BIO-RAD MONOLISA ANTI-HBC April 27,
0467 Laboratories EIA 2007
------------------------------------------------------------------------
P060005/2007M- Siemens IMMULITE/IMMULITE 1000 & May 11,
0409 Medical IMMULITE 2000 FREE PSA 2007
Solutions ASSAYS
Diagnostics
------------------------------------------------------------------------
P060017/2007M- Veridex, LLC GENESEARCH BREAST LYMPH July 16,
0413 NODE (BLN) ASSAY 2007
------------------------------------------------------------------------
P040040/2007M- AGA Medical AMPLATZER MUSCULAR VSD September
0446 Corp. 7, 2007
------------------------------------------------------------------------
P070009/2007M- Obtech Medical REALIZE ADJUSTABLE GASTRIC September
0380 GMBH BAND MODEL 2200-X 28, 2007
------------------------------------------------------------------------
P070012/2007M- Medtronic EXPONENT SELF-EXPANDING October 23,
0411 Vascular CAROTIC STENT SYSTEM WITH 2007
OVER THE WIRE OR RAPID
EXHANGE DELIVERY SYSTEM
------------------------------------------------------------------------
P060038/2007M- Carbomedics, MITROFLOW AORTIC October 23,
0410 Inc. PERICARDIAL HEART VALVE 2007
------------------------------------------------------------------------
H990002/2007M- Genzyme EPICEL (CULTURED EPIDERMAL October 25,
0415 Biosurgery AUTOGRAFTS) 2007
------------------------------------------------------------------------
P060035/2007M- Abbott ARCHITECT CORE-M REAGENT November 6,
0447 Laboratories KIT/CALIBRATORS/CONTROLS 2007
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: May 16, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12012 Filed 5-28-08; 8:45 am]
BILLING CODE 4160-01-S
