Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 52380-52382 [E7-18034]
Download as PDF
<![CDATA[
52380
Federal Register / Vol. 72, No. 177 / Thursday, September 13, 2007 / Notices
https://www.hhs.gov/healthit/ahic/
healthrecords/ehr_instruct.html.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 7, 2007.
Judith Sparrow,
Director, American Health Information
Community, Office of Programs and
Coordination, Office of the National
Coordinator for Health Information
Technology.
[FR Doc. 07–4506 Filed 9–12–07; 8:45 am]
National Committee on Vital and Health
Statistics: Meeting
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
BILLING CODE 4150–24–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology;
American Health Information
Community Personalized Healthcare
Workgroup Meeting
ACTION:
Announcement of meeting.
SUMMARY: This notice announces the
ninth meeting of the American Health
Information Community Personalized
Healthcare Workgroup in accordance
with the Federal Advisory Committee
Act (Pub. L. No. 92–463, 5 U.S.C., App.)
October 25, 2007, from 2 p.m. to
5 p.m. [Eastern Time].
DATES:
Mary C. Switzer Building
(330 C. Street, SW., Washington, DC
20201), Conference Room 4090. Please
bring photo ID for entry to a Federal
building.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
https://www.hhs.gov/healthit/ahic/
healthcare/.
The
Workgroup will discuss possible
common data standards to incorporate
interoperable, clinically useful genetic/
genomic information and analytical
tools into Electronic Health Records
(EHR) to support clinical decisionmaking for the clinician and consumer.
The meeting will be available via Web
cast. For additional information, go to:
https://www.hhs.gov/healthit/ahic/
healthcare/phc_instruct.html.
ebenthall on PRODPC61 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: September 7, 2007.
Judith Sparrow,
Director, American Health Information
Community, Office of Programs and
Coordination, Office of the National
Coordinator for Health Information
Technology.
[FR Doc. 07–4507 Filed 9–12–07; 8:45 am]
BILLING CODE 4150–24–M
VerDate Aug<31>2005
15:29 Sep 12, 2007
Jkt 211001
Dated: September 5, 2007.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation (SDP), Office of the Assistant
Secretary for Planning and Evaluation.
[FR Doc. 07–4508 Filed 9–12–07; 8:45 am]
BILLING CODE 4151–05–M
Name: National Committee on Vital and
Health Statistics (NCVHS).
Time and Date:
September 25, 2007, 9 a.m.–4 p.m.
September 26, 2007, 10 a.m.–2:45 p.m.
Place: Bethesda Marriott Hotel, 5151 Pooks
Hill Road, Bethesda, MD 20814, Phone: (301)
897–9400.
Status: Open.
Purpose: At this meeting the Committee
will hear presentations and hold discussions
on several health data policy topics. On the
morning of the first day the Committee will
hear updates from the Department, the
Centers for Medicare and Medicaid Services,
and the Office of the National Coordinator.
They will also hear updates and status
reports from Subcommittees and hold a
discussion on secondary uses of health
records data. This discussion will be
continued in the afternoon and the
Committee will hear an update from the
Quality Workgroup.
On the morning of the second day the
Committee will review its 2005–2006 report
to Congress and take action on other products
as needed. In the afternoon there will be a
continuation of the discussion on secondary
uses of health record data and the remainder
of the time will be spent on Committee
administrative operations.
The times shown above are for the full
Committee meeting. Subcommittee breakout
sessions are scheduled for late in the
afternoon of the first day and in the morning
prior to the full Committee meeting on the
second day. Agendas for these breakout
sessions will be posted on the NCVHS Web
site (URL below) when available.
Contact Person for More Information:
Substantive program information as well as
summaries of meetings and a roster of
committee members may be obtained from
Marjorie S. Greenberg, Executive Secretary,
NCVHS, National Center for Health Statistics,
Centers for Disease Control and Prevention,
3311 Toledo Road, Room 2402, Hyattsville,
Maryland 20782, telephone (301) 458–4245.
Information also is available on the NCVHS
home page of the HHS Web site: https://
www.ncvhs.hhs.gov/, where further
information including an agenda will be
posted when available.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment Opportunity on
(301) 458–4EEO (4336) as soon as possible.
Food and Drug Administration
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket Nos. 2007M–0174, 2007M–0259,
2007M–0161, 2007M–0160, 2007M–0151,
2007M–0152, 2007M–0153, 2007M–0188,
2007M–0156, 2007M–0154, 2007M–0180,
2007M–0189, 2007M–0190, 2007M–0253,
2007M–0255, 2007M–0254]
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
E:\FR\FM\13SEN1.SGM
13SEN1
52381
Federal Register / Vol. 72, No. 177 / Thursday, September 13, 2007 / Notices
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 April 1, 2007, through
June 30, 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 APRIL 1,
2007, THROUGH JUNE 30, 2007.
PMA No./Docket No.
Applicant
TRADE NAME
Approval Date
Abbott Laboratories
ABBOTT AXSYM HBSAG ASSAY
June 1, 2006
P040048/2007M–0259
Zimmer, Inc.
TRILOGY AB ACETBULAR SYSTEM
June 28, 2006
P060003/2007M–0161
Abbott Laboratories
AXSYM AUSAB REAGENT PACK, STANDARD CALIBRATORS, CONTROLS
August 7, 2006
P060009/2007M–0160
Abbott Laboratories
AXSYM CORE-M 2.0 & 2.0 CONTROLS
August 25, 2006
P050048/2007M–0151
Bio-Rad Laboratories, Inc.
MONOLISA ANTI-HBS EIA
August 25, 2006
P060007/2007M–0152
Abbott Laboratories
ARCHITECT HBSAG REAGENT KIT, CALIBRATORS,
CONTROLS, CONFIRMATORY REAGENT KIT,
CONFIRMATORY MANUAL DILUENT
September 7, 2006
P060012/2007M–0153
Abbott Laboratories
AXSYM CORE 2.0 & AXSYM CORE 2.0 CONTROLS
September 8, 2006
P990037(S24)/2007M–
0188
Vascular Solutions, Inc.
VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
December 22, 2006
H060003/2007M–0156
EV3 Neurovascular
ONYX LIQUID EMBOLIC SYSTEM (ONYX HD–500,
MODEL 105–8101–500)
April 11, 2007
P050046/2007M–0154
Guidant Corp.
ACUITY STEERABLE LEAD MODELS 4554, 4555, &
4556
April 13, 2007
P040024(S006)/2007M–
0180
Medicis Aesthetics Holdings, Inc.
PERLANE INJECTABLE GEL
May 2, 2007
P060011/2007M–0189
Rayner Surgical, Inc.
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
May 3, 2007
H060001/2007M–0190
Cordis Neurovascular, Inc.
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
May 8, 2007
P050004/2007M–0253
Electro Medical Systems (EMS)
S.A.
EMS SWISS DOLORCLAST
May 8, 2007
P050012(S001)/2007M–
0255
Dexcom, Inc.
STS–7 CONTINUOUS GLUCOSE MONITORING SYSTEM
May 31, 2007
P060034/2007M–0254
ebenthall on PRODPC61 with NOTICES
P050049/2007M–0174
Bio-Rad Laboratories
BIO RAD MONOLISA ANTI-HBC IGM EIA
May 31, 2007
VerDate Aug<31>2005
15:29 Sep 12, 2007
Jkt 211001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
E:\FR\FM\13SEN1.SGM
13SEN1
52382
Federal Register / Vol. 72, No. 177 / Thursday, September 13, 2007 / Notices
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: August 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–18034 Filed 9–12–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
U.S Customs and Border Protection
Agency Information Collection
Activities: U.S-Jordan Free Trade
Agreement
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Proposed collection; comments
requested.
ebenthall on PRODPC61 with NOTICES
AGENCY:
SUMMARY: U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act: U.S.-Jordan Free Trade
Agreement. This is a proposed
extension of an information collection
that was previously approved. CBP is
proposing that this information
collection be extended with no change
to the burden hours. This document is
published to obtain comments from the
public and affected agencies. This
proposed information collection was
previously published in the Federal
Register (72 FR 38092) on July 12, 2007,
allowing for a 60-day comment period.
This notice allows for an additional 30
days for public comments. This process
is conducted in accordance with 5 CFR
1320.10.
DATES: Written comments should be
received on or before October 15, 2007.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to Nathan Lesser, Desk Officer,
Department of Homeland Security/
Customs and Border Protection, and
sent via electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–6974.
SUPPLEMENTARY INFORMATION: U.S.
Customs and Border Protection (CBP)
encourages the general public and
VerDate Aug<31>2005
15:29 Sep 12, 2007
Jkt 211001
affected Federal agencies to submit
written comments and suggestions on
proposed and/or continuing information
collection requests pursuant to the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13). Your comments should
address one of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency/component,
including whether the information will
have practical utility;
(2) Evaluate the accuracy of the
agencies/components estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collections of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
Title: U.S.-Jordan Free Trade
Agreement.
OMB Number: 1651–0128.
Form Number: None.
Abstract: The U.S.-Jordan Free Trade
Agreement was established to reduce
and eliminate barriers, strengthen and
develop economic relations, and to lay
the foundations for further cooperation
by reduced duty-treatment on imported
goods.
Current Actions: There are no changes
to the information collection. This
submission is being submitted to extend
the expiration date.
Type of Review: Extension (without
change).
Affected Public: Businesses.
Estimated Number of Respondents:
2,500.
Estimated Time per Respondent: 12
minutes.
Estimated Total Annual Burden
Hours: 500.
Estimated Total Annualized Cost on
the Public: N/A.
If additional information is required
contact: Tracey Denning, U.S. Customs
and Border Protection, 1300
Pennsylvania Avenue, NW., Room
3.2.C, Washington, DC 20229, at 202–
344–1429.
Dated: September 6, 2007.
Tracey Denning,
Agency Clearance Officer, Information
Services Branch.
[FR Doc. E7–18001 Filed 9–12–07; 8:45 am]
BILLING CODE 9111–14–P
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
DEPARTMENT OF HOMELAND
SECURITY
U.S Customs and Border Protection
Agency Information Collection
Activities: Haitian Hemispheric
Opportunity Through Partnership
Encouragement Act of 2006
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Proposed collection; comments
requested.
AGENCY:
SUMMARY: U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act: Haitian Hemispheric
Opportunity Through Partnership
Encouragement (‘‘HOPE’’) Act of 2006.
This is a proposed extension of an
information collection that was
previously approved. CBP is proposing
that this information collection be
extended with no change to the burden
hours. This document is published to
obtain comments from the public and
affected agencies. This proposed
information collection was previously
published in the Federal Register (72
FR 38092) on July 12, 2007, allowing for
a 60-day comment period. This notice
allows for an additional 30 days for
public comments. This process is
conducted in accordance with 5 CFR
1320.10.
DATES: Written comments should be
received on or before October 15, 2007.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to Nathan Lesser, Desk Officer,
Department of Homeland Security/
Customs and Border Protection, and
sent via electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–6974.
SUPPLEMENTARY INFORMATION: U.S.
Customs and Border Protection (CBP)
encourages the general public and
affected Federal agencies to submit
written comments and suggestions on
proposed and/or continuing information
collection requests pursuant to the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13). Your comments should
address one of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 72, Number 177 (Thursday, September 13, 2007)]
[Notices]
[Pages 52380-52382]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18034]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M-0174, 2007M-0259, 2007M-0161, 2007M-0160, 2007M-
0151, 2007M-0152, 2007M-0153, 2007M-0188, 2007M-0156, 2007M-0154,
2007M-0180, 2007M-0189, 2007M-0190, 2007M-0253, 2007M-0255, 2007M-0254]
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
[[Page 52381]]
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 April 1, 2007, through June 30, 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 April 1, 2007, through June 30, 2007.
------------------------------------------------------------------------
PMA No./ Approval
Docket No. Applicant TRADE NAME Date
------------------------------------------------------------------------
P050049/2007M- Abbott ABBOTT AXSYM HBSAG ASSAY June 1,
0174 Laboratories 2006
------------------------------------------------------------------------
P040048/2007M- Zimmer, Inc. TRILOGY AB ACETBULAR June 28,
0259 SYSTEM 2006
------------------------------------------------------------------------
P060003/2007M- Abbott AXSYM AUSAB REAGENT PACK, August 7,
0161 Laboratories STANDARD CALIBRATORS, 2006
CONTROLS
------------------------------------------------------------------------
P060009/2007M- Abbott AXSYM CORE-M 2.0 & 2.0 August 25,
0160 Laboratories CONTROLS 2006
------------------------------------------------------------------------
P050048/2007M- Bio-Rad MONOLISA ANTI-HBS EIA August 25,
0151 Laboratories, 2006
Inc.
------------------------------------------------------------------------
P060007/2007M- Abbott ARCHITECT HBSAG REAGENT September
0152 Laboratories KIT, CALIBRATORS, 7, 2006
CONTROLS, CONFIRMATORY
REAGENT KIT, CONFIRMATORY
MANUAL DILUENT
------------------------------------------------------------------------
P060012/2007M- Abbott AXSYM CORE 2.0 & AXSYM September
0153 Laboratories CORE 2.0 CONTROLS 8, 2006
------------------------------------------------------------------------
P990037(S24)/ Vascular VASCULAR SOLUTIONS D-STAT December
2007M-0188 Solutions, Inc. FLOWABLE HEMOSTAT 22, 2006
------------------------------------------------------------------------
H060003/2007M- EV3 Neurovascular ONYX LIQUID EMBOLIC SYSTEM April 11,
0156 (ONYX HD-500, MODEL 105- 2007
8101-500)
------------------------------------------------------------------------
P050046/2007M- Guidant Corp. ACUITY STEERABLE LEAD April 13,
0154 MODELS 4554, 4555, & 4556 2007
------------------------------------------------------------------------
P040024(S006)/ Medicis PERLANE INJECTABLE GEL May 2,
2007M-0180 Aesthetics 2007
Holdings, Inc.
------------------------------------------------------------------------
P060011/2007M- Rayner Surgical, C-FLEX MODEL 570C May 3,
0189 Inc. INTRAOCULAR LENS (IOL) 2007
------------------------------------------------------------------------
H060001/2007M- Cordis ENTERPRISE VASCULAR May 8,
0190 Neurovascular, RECONSTRUCTION DEVICE AND 2007
Inc. DELIVERY SYSTEM
------------------------------------------------------------------------
P050004/2007M- Electro Medical EMS SWISS DOLORCLAST May 8,
0253 Systems (EMS) 2007
S.A.
------------------------------------------------------------------------
P050012(S001)/ Dexcom, Inc. STS-7 CONTINUOUS GLUCOSE May 31,
2007M-0255 MONITORING SYSTEM 2007
------------------------------------------------------------------------
P060034/2007M- Bio-Rad BIO RAD MONOLISA ANTI-HBC May 31,
0254 Laboratories IGM EIA 2007
------------------------------------------------------------------------
[[Page 52382]]
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: August 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-18034 Filed 9-12-07; 8:45 am]
BILLING CODE 4160-01-S
