Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 11986-11987 [05-4763]
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11986
Federal Register / Vol. 70, No. 46 / Thursday, March 10, 2005 / Notices
Dated: March 1, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Office of
the Chief Science Officer, Centers for Disease
Control and Prevention.
[FR Doc. 05–4687 Filed 3–9–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Information Collections Related
to Reunification Procedures for
Unaccompanied Alien Children.
OMB No.: New collection.
Description: Following the passage of
the 2002 Homeland Security Act (Pub.
L. 107–296), the Administration for
background check. Suitable sponsors
may be parents, close relatives, friends
or entities concerned with the child’s
welfare. In this Notice, ACF announces
that it proposes to employ the use of
several information collections for
recording: (1) The Sponsor’s Agreement
to Conditions of Release, which collects
the sponsor’s affirmation to the terms of
the release; (2) the Verification of
Release, which collects the children’s
affirmation to the terms of their release;
(3) the Family Reunification Packet,
which collects information related to
the sponsor’s ability to provide for the
physical, mental and financial wellbeing of the child(ren) and (4) the
Authorization for Release of
Information, which collects information
to be utilized for a background check.
Respondents: Potential sponsors of
unaccompanied alien children and
unaccompanied alien children in
Federal custody.
Children and Families (ACF), Office of
Refugee Resettlement (ORR), is charged
with the care and placement of
unaccompanied alien children in
Federal custody, and implementing a
policy for the release of these children,
when appropriate, upon the request of
suitable sponsors while awaiting
immigration proceedings. In order for
ORR to make determinations regarding
the release of these children, the
potential sponsors must meet certain
conditions pursuant to section 462 of
the Homeland Security Act and the
Flores v. Reno Settlement Agreement
No. CV85–4544–RJK (C.D. Cal. 1997).
ORR considers the suitability of a
sponsor based on the sponsor’s ability
and agreement to provide for the
physical, mental and financial wellbeing of an unaccompanied minor and
assurance to appear before immigration
courts. To ensure the safety of the
children, sponsors must undergo a
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Sponsor’s Agreement ....................................................................................
Verification of Release ...................................................................................
Family Reunification Packet ..........................................................................
Authorization for Release of Information .......................................................
Estimated Total Annual Burden
Hours: 5,800.
Additional Information: Copies of the
proposed collections may be obtained
by writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
grjohnsno@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after the publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collections
should be sent directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Attn:
Desk Officer for ACF. E-mail address:
Katherine T. Astrich@omb.eop.gov.
VerDate jul<14>2003
18:28 Mar 09, 2005
Jkt 205001
Number of
responses per
respondent
3,000
3,000
3,000
3,000
Dated: March 4, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–4692 Filed 3–9–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004M–0538, 2004M–0495,
2004M–0450, 2004M–0467, 2004M–0471,
2004M–0533, 2004M–0496, 2004M–0497]
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.
PO 00000
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1
1
20
12
Average
burden hours
per response
.166666
.166666
.05
.05
Total
burden
hours
500
500
3,000
1,800
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
Corporate Blvd., Rockville, MD 20850,
301–594–2186.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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
E:\FR\FM\10MRN1.SGM
10MRN1
Federal Register / Vol. 70, No. 46 / Thursday, March 10, 2005 / Notices
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 this30 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.
11987
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, 2004, through
December 31, 2004. 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,
2004, THROUGH DECEMBER 31, 2004
PMA No./Docket No.
Applicant
Trade Name
Approval Date
P020022/2004M–0538
Bayer Healthcare, LLC
BAYER VERSANT HCV RNA 3.0
ASSAY (bDNA)
March 28, 2003
P020021/2004M–0495
Wilson-Cook Medical, Inc./applicant at approval was
Axcan Scandipharm, Inc.
WIZARD X-CELL
PHOTODYNAMIC THERAPY
BALLOON WITH FIBER OPTIC
DIFFUSER
August 1, 2003
P040029/2004M–0450
Szabocsik & Associates
JSZ ORTHOKERATOLOGY
(OPRIFOCON A) CONTACT
LENSES FOR OVERNIGHT
WEAR
P030032(S1)/2004M–0467
Genzyme Biosurgery
HYLAFORM PLUS (HYLAN B
GEL)
October 13, 2004
P030011/2004M–0471
Syncardia Systems, Inc.
SYNCARDIA TEMPORARY
CARDO WEST TOTAL
ARTIFICAL HEART (TAH-t)
October 15, 2004
P040002/2004M–0533
Endologix, Inc.
ENDOLOGIX POWERLINK SYSTEM
October 29, 2004
P040022/2004M–0496
Medtronic, Inc./applicant at approval was AngioLink Corp.
EVS VASCULAR CLOSURE SYSTEM
November 3, 2004
P030031/2004M–0497
Biosense Webster, Inc.
BIOSENSE WEBSTER
NAVISTAR/CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION
DEFLECTABLE TIP CATHETERS
November 5, 2004
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: March 2, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–4763 Filed 3–9–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0069]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Instrumentation for Clinical Multiplex
Test Systems; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
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18:28 Mar 09, 2005
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September 29, 2004
availability of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Instrumentation
for Clinical Multiplex Test Systems.’’
This guidance document describes a
means by which instrumentation for
clinical multiplex test systems may
comply with the requirements of special
controls for class II devices. It includes
recommendations for validation of
performance characteristics and
recommendations for product labeling.
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
to classify instrumentation for clinical
multiplex test systems into class II
(special controls). This guidance
document is immediately in effect as the
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]]>Agencies
[Federal Register Volume 70, Number 46 (Thursday, March 10, 2005)]
[Notices]
[Pages 11986-11987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4763]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004M-0538, 2004M-0495, 2004M-0450, 2004M-0467, 2004M-
0471, 2004M-0533, 2004M-0496, 2004M-0497]
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
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
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
[[Page 11987]]
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, 2004, through December 31,
2004. 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, 2004, through December 31, 2004
------------------------------------------------------------------------
PMA No./Docket
No. Applicant Trade Name Approval Date
------------------------------------------------------------------------
P020022/2004M- Bayer BAYER VERSANT March 28, 2003
0538 Healthcare, HCV RNA 3.0
LLC ASSAY (bDNA)
------------------------------------------------------------------------
P020021/2004M- Wilson-Cook WIZARD X-CELL August 1, 2003
0495 Medical, PHOTODYNAMIC
Inc./ THERAPY
applicant BALLOON WITH
at approval FIBER OPTIC
was Axcan DIFFUSER
Scandipharm
, Inc.
------------------------------------------------------------------------
P040029/2004M- Szabocsik & JSZ September 29, 2004
0450 Associates ORTHOKERATOLO
GY (OPRIFOCON
A) CONTACT
LENSES FOR
OVERNIGHT
WEAR
------------------------------------------------------------------------
P030032(S1)/2004M- Genzyme HYLAFORM PLUS October 13, 2004
0467 Biosurgery (HYLAN B GEL)
------------------------------------------------------------------------
P030011/2004M- Syncardia SYNCARDIA October 15, 2004
0471 Systems, TEMPORARY
Inc. CARDO WEST
TOTAL
ARTIFICAL
HEART (TAH-t)
------------------------------------------------------------------------
P040002/2004M- Endologix, ENDOLOGIX October 29, 2004
0533 Inc. POWERLINK
SYSTEM
------------------------------------------------------------------------
P040022/2004M- Medtronic, EVS VASCULAR November 3, 2004
0496 Inc./ CLOSURE
applicant SYSTEM
at approval
was
AngioLink
Corp.
------------------------------------------------------------------------
P030031/2004M- Biosense BIOSENSE November 5, 2004
0497 Webster, WEBSTER
Inc. NAVISTAR/
CELSIUS
THERMO-COOL
DIAGNOSTIC/
ABLATION
DEFLECTABLE
TIP CATHETERS
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: March 2, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-4763 Filed 3-9-05; 8:45 am]
BILLING CODE 4160-01-S
