Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 55852-55853 [E8-22668]
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55852
Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices
jlentini on PROD1PC65 with NOTICES
written or electronic comments on the
draft guidance by November 25, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Robert Powell, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 4526,
Silver Spring, MD 20993–0002, 301–
796–1589
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘End-of-Phase 2A Meetings.’’ This draft
guidance will meet one of the
performance goals agreed to under the
September 27, 2007, reauthorization of
the Prescription Drug User Fee Act
(PDUFA IV). Under section XI of the
PDUFA IV Performance Goals,
Expediting Drug Development, FDA
agreed to publish by the end of fiscal
year 2008 a draft guidance on end-ofphase 2A meetings (see section XI.A.4 at
https://www.fda.gov/oc/pdufa4/
pdufa4goals.html). This draft guidance
is intended to facilitate early meetings
(referred to as end-of-phase 2A meetings
or EOP2A meetings) between FDA and
sponsors who seek interaction or
guidance related to the use of
quantitative drug development methods
(i.e., exposure-response,
pharmacokinetic/pharmacodynamic
(PK/PD) modeling, drug-disease
modeling, genomic analysis) to inform
drug development and regulatory
decisions. The draft guidance provides
recommendations to IND sponsors on
the following topics:
• Objectives of an EOP2A meeting,
• Possible topics for discussion at
EOP2A meetings,
• Useful information for an EOP2A
meeting package, and
• Timing of EOP2A meetings.
This draft guidance is being issued
consistent with FDA’s good guidance
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practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on end-of-phase 2A meetings. 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. 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.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 and
the guidance on ‘‘Formal Meetings With
Sponsors and Applicants for PDUFA
Products’’ have been approved under
OMB control numbers 0910–0014 and
0910–0429, respectively.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
www.regulations.gov.
Dated: September 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–22669 Filed 9–25–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–M–0207, FDA–
2008–M–0243, FDA–2008–M–0244, FDA–
2008–M–0283, FDA–2008–M–0335, FDA–
2008–M–0311, FDA–2008–M–0342, FDA–
2008–M–0378]
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:
Nicole Wolanski, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4010.
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
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Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices
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
55853
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 April 1, 2008, through
June 30, 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 APRIL 1,
2008, THROUGH JUNE 30, 2008
PMA No./Docket No.
Applicant
TRADE NAME
Approval Date
P050020
FDA–2008–M–0207
Abbott Diabetes Care, Inc.
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE
MONITORING SYSTEM
March 12, 2008
P010012 (S037)
FDA–2008–M–0243
Guidant Corp.
Contak Renewal 3 AVT system & contak reviewal 3AVT
HE System
March 13, 2008
P070027
FDA–2008–M–0244
Medtronic Vascular
The talent abdominal stent graft system
April 15, 2008
P060040
FDA–2008–M–0283
Thoratec Corp.
Thoratec Heartmate II Left ventricular assist
April 21, 2008
P070008
FDA–2008–M–0335
Biotronik, Inc.
Stratos LV CRT–P & stratos LV–T CRT–P, corox OTW
BP lead & corox OTW-s bp lead
May 12, 2008
P070016
FDA–2008–M–0311
Cook, Inc.
Zenith TX2 Thoracic TAA endovascular graft with the
H&LB One-shot introduction system
May 21, 2008
P070007
FDA–2008–M–0342
Medtronic Vascular
Talent Thoracic Stent Graft System
June 5, 2008
H070003
FDA–2008–M–0378
Synapse Biomedical, Inc.
NeuRx RA/4
June 17, 2008
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: September 12, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E8–22668 Filed 9–25–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
Methods for Preparing Bacillus
anthracis Protective Antigen for Use
in Vaccines
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
Description of Technology: This
invention relates to improved methods
of preparing Bacillus anthracis
protective antigen (PA) from a cell or
AGENCY:
jlentini on PROD1PC65 with NOTICES
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.
ADDRESSES: 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.
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organism, particularly a recombinant
cell or microorganism, for use in
vaccines. Production and purification
methods of modified PA from a nonsporogenic strain of Bacillus anthracis
are described. Specifically, a scalable
fermentation and purification process is
claimed that is suitable for vaccine
development, and that produces almost
three times more product than earlierreported processes. This is
accomplished using a biologically
inactive protease-resistant PA variant in
a protease-deficient non-sporogenic
avirulent strain of B. anthracis (BH445).
One of the PA variants described in the
patent application lacks the furin and
chymotrypsin cleavage sites.
Advantages: Bacillus anthracis
protective antigen is a major component
of the currently licensed human vaccine
(Anthrax Vaccine Adsorbed, AVA).
Although the current human vaccine
has been shown to be effective against
cutaneous anthrax infection in animals
and humans and against inhalation
anthrax in rhesus monkeys, the licensed
vaccine has several limitations: (1) AVA
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]]>Agencies
[Federal Register Volume 73, Number 188 (Friday, September 26, 2008)]
[Notices]
[Pages 55852-55853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22668]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-M-0207, FDA-2008-M-0243, FDA-2008-M-0244, FDA-
2008-M-0283, FDA-2008-M-0335, FDA-2008-M-0311, FDA-2008-M-0342, FDA-
2008-M-0378]
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: Nicole Wolanski, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-4010.
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
[[Page 55853]]
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 April 1, 2008, through June 30, 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 April 1, 2008, through June 30, 2008
------------------------------------------------------------------------
PMA No./ Approval
Docket No. Applicant TRADE NAME Date
------------------------------------------------------------------------
P050020 Abbott Diabetes FREESTYLE NAVIGATOR March 12,
FDA-2008-M-02 Care, Inc. CONTINUOUS GLUCOSE 2008
07 MONITORING SYSTEM
------------------------------------------------------------------------
P010012 Guidant Corp. Contak Renewal 3 AVT March 13,
(S037) system & contak reviewal 2008
FDA-2008-M-02 3AVT HE System
43
------------------------------------------------------------------------
P070027 Medtronic The talent abdominal stent April 15,
FDA-2008-M-02 Vascular graft system 2008
44
------------------------------------------------------------------------
P060040 Thoratec Corp. Thoratec Heartmate II Left April 21,
FDA-2008-M-02 ventricular assist 2008
83
------------------------------------------------------------------------
P070008 Biotronik, Inc. Stratos LV CRT-P & stratos May 12,
FDA-2008-M-03 LV-T CRT-P, corox OTW BP 2008
35 lead & corox OTW-s bp
lead
------------------------------------------------------------------------
P070016 Cook, Inc. Zenith TX2 Thoracic TAA May 21,
FDA-2008-M-03 endovascular graft with 2008
11 the H&LB One-shot
introduction system
------------------------------------------------------------------------
P070007 Medtronic Talent Thoracic Stent June 5,
FDA-2008-M-03 Vascular Graft System 2008
42
------------------------------------------------------------------------
H070003 Synapse NeuRx RA/4 June 17,
FDA-2008-M-03 Biomedical, Inc. 2008
78
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: September 12, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-22668 Filed 9-25-08; 8:45 am]
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