Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 50826-50827 [E8-19907]
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50826
Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the content and format of the ISE. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520). The collections of
information in 21 CFR part 314 have
been approved under 0910–0001. The
collections of information for
submission of data in a BLA under 21
CFR 601.2 have been approved under
0910–0338.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/cber/
guidelines.htm or https://
www.regulations.gov.
I. Background
Dated: August 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19906 Filed 8–27–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–M–0084, FDA–
2008–M–0100 (formerly 2008M–0013), FDA–
2008–M–0182, FDA–2008–M–0109, FDA–
2008–M–0207]
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:
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 January 1, 2008, through
March 31, 2008. 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 JANUARY 1,
2008, THROUGH MARCH 31, 2008
jlentini on PROD1PC65 with NOTICES
PMA No.
Docket No.
P040021 (S004)
FDA–2008–M–0084
VerDate Aug<31>2005
17:36 Aug 27, 2008
Applicant
TRADE NAME
St. Jude Medical, Inc.
Jkt 214001
PO 00000
Frm 00071
Approval Date
SJM EPIC VALVE AND SJM SUPRA VALVE
Fmt 4703
Sfmt 4703
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28AUN1
November 15, 2007
Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices
50827
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2008, THROUGH MARCH 31, 2008—Continued
PMA No.
Docket No.
Applicant
TRADE NAME
Approval Date
P070001
FDA–2008–M–0100 (formerly
2008M–0013)
Synthes Spine, Inc.
PRODISC–C TOTAL DISC PEPLACEMENT
December 17, 2007
P050045
FDA–2008–M–0182
Dako Denmark a/s
DAKO TOP2A FISH PHARM DX KIT
January 11, 2008
P060033
FDA–2008–M–0109
Medtronic Vascular
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY
STENT ON THE OVER THE WIRE (OTW), RAPID
EXCHANGE (RX), OR MULTI-EXHANGE II (MX2)
STENT DELIVERY SYSTEM
February 1, 2008
Identification and Characterization of
Folliculin-Interacting Protein 2, FNIP2
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: August 14, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E8–19907 Filed 8–27–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
jlentini on PROD1PC65 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
17:36 Aug 27, 2008
Jkt 214001
Description of Technology: The
invention describes the identification
and characterization of a FNIP1
homolog, folliculin-interacting protein 2
(FNIP2), that interacts with folliculin,
the protein encoded by the FLCN gene,
which is responsible for the Birt-HoggDube’ (BHD) syndrome. BHD is a
dermatologic disorder associated with
an increased risk for developing renal
cancer, spontaneous pneumothorax and
lung cysts. FNIP2 binds to the
C-terminus of folliculin and to AMPK.
Importantly, FNIP2 expression was
elevated in renal tumors seen in BDH
patients. This finding suggests that
FNIP2 may serve as a biomarker for
BHD.
Applications: Research tool;
Diagnostic applications.
Advantages: Could facilitate the
development of therapeutic drugs to
treat the skin lesions and renal tumors
that develop in BHD patients.
Development Status: Early stage of
development.
Market: Dermatologic products;
Diagnostic applications.
Inventors: Laura S. Schmidt et al.
(NCI).
Relevant Publication: H Hasumi et al.
Identification and characterization of a
novel folliculin-interacting protein
FNIP2. (2008) Gene, in press.
Patent Status: HHS Reference No. E–
213–2008/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
biological materials licensing only.
Licensing Contact: John Stansberry,
Ph.D.; 301–435–5236;
stansbej@mail.nih.gov.
Collaborative Research Opportunity:
The Urologic Oncology Branch at the
National Cancer Institute is seeking
statements of capability or interest from
parties interested in collaborative
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
research to further develop, evaluate, or
commercialize detection methods
specific for FNIP2 to be used to screen
FNIP2 as a biomarker for renal cancer.
This may include development of an
efficient FNIP2 antibody which does not
cross react with FNIP1 for
immunhistochemical screening of renal
tumors for FNIP2 expression. Please
contact John D. Hewes, Ph.D. at 301–
435–3121 or hewesj@mail.nih.gov for
more information.
Immunotoxins Made With Modified
Cholix Toxin and Uses Thereof
Description of Technology:
Immunotoxins are chimeric molecules
comprising an antibody targeting moiety
and a toxin domain capable of killing a
cell. Immunotoxins represent an
important therapeutic tool for the
treatment of cancer because they are
able to specifically target cancer cells
while ignoring healthy cells. The major
drawback to immunotoxins is the
development of neutralizing antibodies
against the toxin portion of the
immunotoxin. Many patients treated
with Pseudomonas exotoxin A (PE)
based immunotoxins develop
neutralizing antibodies after the first
administration. As a result, only one
effective administration of a PE-based
immunotoxin is often possible.
NIH inventors have created a novel
immunotoxin, where the toxin portion
is a truncated Cholera exotoxin (cholix
toxin). Although cholix toxin retains
strong functional and structural
similarity to PE, neutralizing antibodies
to PE do not affect the truncated cholix
toxin. As a result, cholix toxin-based
immunotoxins are of potential utility
after a patient has developed
neutralizing antibodies to PE. The
ability to deliver two rounds of
immunotoxins to a patient will increase
the successful treatment of various
diseases, including cancer.
Application:
E:\FR\FM\28AUN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 168 (Thursday, August 28, 2008)]
[Notices]
[Pages 50826-50827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19907]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-M-0084, FDA-2008-M-0100 (formerly 2008M-0013),
FDA-2008-M-0182, FDA-2008-M-0109, FDA-2008-M-0207]
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:
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 January 1, 2008, through March 31,
2008. 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 January 1, 2008, through March 31, 2008
------------------------------------------------------------------------
PMA No. Docket Approval
No. Applicant TRADE NAME Date
------------------------------------------------------------------------
P040021 (S004) St. Jude SJM EPIC VALVE AND SJM November 15,
FDA-2008-M-0084 Medical, Inc. SUPRA VALVE 2007
------------------------------------------------------------------------
[[Page 50827]]
P070001 Synthes Spine, PRODISC-C TOTAL DISC December 17,
FDA-2008-M-0100 Inc. PEPLACEMENT 2007
(formerly 2008M-
0013)
------------------------------------------------------------------------
P050045 Dako Denmark a/ DAKO TOP2A FISH PHARM DX January 11,
FDA-2008-M-0182 s KIT 2008
------------------------------------------------------------------------
P060033 Medtronic ENDEAVOR ZOTAROLIMUS- February 1,
FDA-2008-M-0109 Vascular ELUTING CORONARY STENT 2008
ON THE OVER THE WIRE
(OTW), RAPID EXCHANGE
(RX), OR MULTI-EXHANGE
II (MX\2\) STENT
DELIVERY SYSTEM
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: August 14, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-19907 Filed 8-27-08; 8:45 am]
BILLING CODE 4160-01-S
