Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 15885-15886 [E7-6166]
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15885
Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices
update on AHRQ’s current research,
programs, and initiatives. The Chair will
officially welcome new members to the
Council. The official agenda will be
available on AHRQ’s Web site at
www.ahrq.gov no later than April 9,
2007.
Dated: March 26, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–1642 Filed 3–29–07; 5:05 pm]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-07–06AC]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Joan F. Karr, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Low Back Exposure Assessment Tool
for Mining—NEW—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Federal Mine Safety & Health Act
of 1977, Section 501, enables CDC/
NIOSH to carry out research relevant to
the health and safety of workers in the
mining industry. Mining has one of the
highest incidence rates for back pain of
any industry, and back injuries are
consistently the leading cause of lost
work days in the industry. The objective
of this project is to develop a selfadministered, paper and pencil risk
assessment tool for the development of
low back disorders specifically directed
towards use in the mining industry.
Many current methods of assessing the
risk of low back disorders do not
address stressors that are relatively
unique to the mining environment,
including the restricted vertical spaces
in many coal mines that require workers
to adopt stooping or kneeling postures
for extended periods of their workday.
The low back exposure assessment
tool for mining will assess various
occupational exposures associated with
development of back disorders in the
literature (postural demands, lifting,
whole body vibration exposure,
individual and psychosocial issues), as
well as specific mining stressors and
will develop a score that will be used
to assess the degree of risk for the job
and the individual. The tool will be
useful in both prioritizing jobs that need
interventions to reduce low back
disorder risk, and in evaluating the
effectiveness of interventions through
tool administration before and after the
implementation of an intervention.
There will be no cost to the respondents
other than their time.
Estimated Annualized Burden Hours:
Respondents
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Surface and Underground Miners ................................................................
320 miners .......
1
15/60
80
Dated: March 27, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–6139 Filed 4–2–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M–0411, 2006M–0512,
2006M–0412, 2006M–0396, 2006M–0460,
2006M–0456, 2006M–0459, 2006M–0455,
2006M–0457, 2006M–0473, 2006M–0490,
2006M–0492, 2006M–0529, 2006M–0530 and
2006M–0531]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ycherry on PROD1PC64 with NOTICES
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
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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 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:
Thinh Nguyen, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
E:\FR\FM\03APN1.SGM
03APN1
15886
Federal Register / Vol. 72, No. 63 / Tuesday, April 3, 2007 / Notices
Corporate Blvd., Rockville, MD 20850,
301–594–2186, ext. 152.
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 Web site 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, 2006, through
December 31, 2006. 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,
2006, THROUGH DECEMBER 31, 2006.
PMA No./Docket No.
Applicant
Trade Name
Approval Date
P040027/2006M–0411
W.L. Gore & Associates
GORE VIATORR TIPS
December 6, 2004
P040023/2006M–0512
DePuy Orthopedics, Inc.
DURALOC OPTION CERAMIC HIP SYSTEM
May 3, 2005
P030047/2006M–0412
Cordis Corp.
CORDIS PRECISE NITINOL STENT
September 22, 2006
P050038/2006M–0396
Medafor, Inc.
ARISTA AH ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
September 26, 2006
P970053(S9)/2006M–0460
Nidek, Inc.
NIDEK EC–5000 EXCIMER LASER
October 11, 2006
P050022/2006M–0456
Siemens Medical Solutions
USA, Inc.
SYNGO LUNG COMPUTER ASSISTED DETECTION
(CAD) SYSTEM
October 18, 2006
P050025/2006M–0459
Endotex Interventional Systems, Inc.
ENDOTEX NEXSTENT CAROTID STENT & DELIVERY
SYSTERM; AND ENDOTEX NEXSTENT CAROTID
STENT & MONORAIL DELIVERY SYSTERM
October 27, 2006
P020012/2006M–0455
Artes Medical USA, Inc.
ARTEFILL
October 27, 2006
P040050/2006M–0457
Uroplasty, Inc.
MACROPLASTIQUE IMPLANTS
October 30, 2006
P050031/2006M–0473
Paragon Vision Sciences
PARAGON Z CRT
November 16, 2006
P020056/2006M–0490
Allergan
INAMED SILICONE-FILLED BREAST IMPLANTS
November 17, 2006
P030053/2006M–0492
Mentor Corp.
MENTOR MEMORYGEL SILICONE GEL-FILLED
BREAST IMPLANTS
November 17, 2006
P060010/2006M–0529
AbbeyMoor Medical, Inc.
THE SPANNER TEMPORARY PROSTATIC STENT
December 14, 2006
P040025/2006M–0530
Olympic Medical
OLYMPIC COOL-CAP
December 20, 2006
P050033/2006M–0531
Anika Therapeutics, Inc.
COSMETIC TISSUE AUGMENTATION PRODUCT
December 20, 2006
II. Electronic Access
ycherry on PROD1PC64 with NOTICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: March 22, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–6166 Filed 4–2–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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]]>Agencies
[Federal Register Volume 72, Number 63 (Tuesday, April 3, 2007)]
[Notices]
[Pages 15885-15886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6166]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M-0411, 2006M-0512, 2006M-0412, 2006M-0396, 2006M-
0460, 2006M-0456, 2006M-0459, 2006M-0455, 2006M-0457, 2006M-0473,
2006M-0490, 2006M-0492, 2006M-0529, 2006M-0530 and 2006M-0531]
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 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: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
[[Page 15886]]
Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.
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 Web site 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, 2006, through December 31,
2006. 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, 2006, through December 31, 2006.
------------------------------------------------------------------------
PMA No./Docket Approval
No. Applicant Trade Name Date
------------------------------------------------------------------------
P040027/2006M- W.L. Gore & GORE VIATORR TIPS December 6,
0411 Associates 2004
------------------------------------------------------------------------
P040023/2006M- DePuy DURALOC OPTION CERAMIC HIP May 3, 2005
0512 Orthopedics, SYSTEM
Inc.
------------------------------------------------------------------------
P030047/2006M- Cordis Corp. CORDIS PRECISE NITINOL September
0412 STENT 22, 2006
------------------------------------------------------------------------
P050038/2006M- Medafor, Inc. ARISTA AH ABSORBABLE September
0396 HEMOSTATIC, NON-COLLAGEN 26, 2006
BASED
------------------------------------------------------------------------
P970053(S9)/ Nidek, Inc. NIDEK EC-5000 EXCIMER October 11,
2006M-0460 LASER 2006
------------------------------------------------------------------------
P050022/2006M- Siemens SYNGO LUNG COMPUTER October 18,
0456 Medical ASSISTED DETECTION (CAD) 2006
Solutions SYSTEM
USA, Inc.
------------------------------------------------------------------------
P050025/2006M- Endotex ENDOTEX NEXSTENT CAROTID October 27,
0459 Interventiona STENT & DELIVERY SYSTERM; 2006
l Systems, AND ENDOTEX NEXSTENT
Inc. CAROTID STENT & MONORAIL
DELIVERY SYSTERM
------------------------------------------------------------------------
P020012/2006M- Artes Medical ARTEFILL October 27,
0455 USA, Inc. 2006
------------------------------------------------------------------------
P040050/2006M- Uroplasty, MACROPLASTIQUE IMPLANTS October 30,
0457 Inc. 2006
------------------------------------------------------------------------
P050031/2006M- Paragon Vision PARAGON Z CRT November
0473 Sciences 16, 2006
------------------------------------------------------------------------
P020056/2006M- Allergan INAMED SILICONE-FILLED November
0490 BREAST IMPLANTS 17, 2006
------------------------------------------------------------------------
P030053/2006M- Mentor Corp. MENTOR MEMORYGEL SILICONE November
0492 GEL-FILLED BREAST 17, 2006
IMPLANTS
------------------------------------------------------------------------
P060010/2006M- AbbeyMoor THE SPANNER TEMPORARY December
0529 Medical, Inc. PROSTATIC STENT 14, 2006
------------------------------------------------------------------------
P040025/2006M- Olympic OLYMPIC COOL-CAP December
0530 Medical 20, 2006
------------------------------------------------------------------------
P050033/2006M- Anika COSMETIC TISSUE December
0531 Therapeutics, AUGMENTATION PRODUCT 20, 2006
Inc.
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: March 22, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-6166 Filed 4-2-07; 8:45 am]
BILLING CODE 4160-01-S
