Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 11734-11735 [E9-6026]
Download as PDF
<![CDATA[
sroberts on PROD1PC70 with NOTICES
11734
Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices
0242); Frequency: Weekly; Affected
Public: Individuals or households and
State, Local or Tribal Government;
Number of Respondents: 54; Total
Annual Responses: 2442; Total Annual
Hours: 4884. (For policy questions
regarding this collection contact JoAnn
Perry at 410–786–3336. For all other
issues call 410–786–1326.)
7. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Rehabilitation
Hospital Criteria Worksheet and
Rehabilitation Hospital Criteria
Worksheet; Use: The rehabilitation
hospital and rehabilitation unit criteria
worksheets are necessary to verify that
these facilities/units comply and remain
in compliance with the exclusion
criteria for the Medicare prospective
payment system. Form Number: CMS–
437A and 437B (OMB# 0938–0986);
Frequency: Annually; Affected Public:
Business or other for-profit; Number of
Respondents: 1227; Total Annual
Responses: 1227; Total Annual Hours:
307. (For policy questions regarding this
collection contact Georgia Johnson at
410–786–6859. For all other issues call
410–786–1326.)
8. Type of Information Collection
Request: New collection; Title of
Information Collection: State Plan
Amendment Template for 1915(i) State
Plan Home and Community-Based
Services (HCBS) Benefit; Use: Section
6086 of the Deficit Reduction Act
(DRA), expanded access to HCBS for the
elderly and disabled and added a new
section 1915(i) to the Social Security
Act. Under 1915(i), States can amend
their State plans to add these services.
The template includes the information
needed by CMS to determine whether
the State’s services will meet the
requirements under 1915(i). Form
Number: CMS–10259 (OMB# 0938NEW); Frequency: Once; Affected
Public: State, Local or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 3; Total
Annual Hours: 240. (For policy
questions regarding this collection
contact Kathy Poisal at 410–786–5940.
For all other issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
VerDate Nov<24>2008
17:17 Mar 18, 2009
Jkt 217001
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on April 20, 2009.
OMB, Office of Information and
Regulatory Affairs.
Attention: CMS Desk Officer.
Fax Number: (202) 395–6974.
E-mail:
OIRA_submission@omb.eop.gov.
Dated: March 12, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–6041 Filed 3–18–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–M–0535, FDA–
2008–M–0547, FDA–2008–M–0536, FDA–
2008–M–0563, FDA–2008–M–0593, FDA–
2008–M–0601, FDA–2008–M–0562, FDA–
2008–M–0596, FDA–2008–M–0579, FDA–
2008–M–0594, FDA–2008–M–0608, FDA–
2008–M–0645, FDA–2008–M–0646]
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.
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
ADDRESSES:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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
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, 2008, through
December 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.
E:\FR\FM\19MRN1.SGM
19MRN1
11735
Federal Register / Vol. 74, No. 52 / Thursday, March 19, 2009 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2008, THROUGH DECEMBER 31, 2008.
PMA No./Docket No.
Applicant
TRADE NAME
Approval Date
P070015
FDA–2008–M–0535
Abbott Vascular Inc.
XIENCE V EVEROLIMUS ELUTING CORONARY STENT
SYSTEM & PROMUS ELUTING CORONARY STENT SYSTEM
July 2, 2008
P030025 (S28)
FDA–2008–M–0547
Boston Scientific Corp.
TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY
STENT SYSTEM
September 24, 2008
P080004
FDA–2008–M–0536
Hoya Surgical Optics, Inc.
HOYA ISPHERIC MODEL YA–60BB INTRAOCULAR LENS
September 26, 2008
H070004
FDA–2008–M–0563
Levitronix, LLC
LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST
SYSTEM (RVAS)
October 7, 2008
P060008
FDA–2008–M–0593
Boston Scientific Corp.
TAXUS LIBERTE’ PACLITAXEL ELUTING CORONARY
STENT SYSTEM
October 10, 2008
P050029
FDA–2008–M–0601
Stereotaxis, Inc.
HELIOS II ABLATION CATHETER
October 10, 2008
H040004
FDA–2008–M–0562
Medtronic Sofamor Danek
USA, Inc.
INFUSE/MASTERGRAFT POSTEROLATERAL REVISION
DEVICE
October 10, 2008
P050019
FDA–2008–M–0596
Boston Scientific Corp.
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
October 23, 2008
H060002
FDA–2008–M–0579
Spiration, Inc.
IBV VALVE SYSTEM
October 24, 2008
P060025
FDA–2008–M–0594
ATS Medical, Inc.
ATS 3F AORTIC BIOPROSTHESIS
October 30, 2008
P080011
FDA–2008–M–0608
Coopervision Manufacturing, Ltd.
BIOFINITY COMFILCON A (EXTENDED WEAR SOFT CONTACT LENSES)
November 19, 2008
P080007
FDA–2008–M–0645
Bard Peripheral Vascular
Inc.
BARD E-LUMINEXX VASCULAR STENT
December 4, 2008
P060006
FDA–2008–M–0646
Boston Scientific Corp.
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL
PREMOUNTED STENT SYSTEM
December 11, 2008
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E9–6026 Filed 3–18–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sroberts on PROD1PC70 with NOTICES
Proposed Collection; Comment
Request; Simulations for Drug Related
Science Education
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has
VerDate Nov<24>2008
17:17 Mar 18, 2009
Jkt 217001
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
June 26, 2008, (Vol. 73 No. 124, page
36337) and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after November 15,
2008, unless it displays a currently valid
OMB control number.
Proposed Collection: Title:
Simulations for Drug Related Science
Education. Type of Information
Collection Request: NEW. Need and Use
of Information Collection: This is a
request for a one-time clearance to
evaluate an interactive multimedia
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
module developed by ArchieMD. This
evaluation seeks to determine whether
the multimedia module Archie MD: The
Science of Drugs (1) Increases students’
knowledge in brain and heart biology
and the effects drugs have on the body
(2) Increases positive attitudes towards
science education for high school
students (3) Reinforce or instill negative
attitudes towards substance abuse. In
order to test the effectiveness of the
interactive multimedia module, data
will be collected in the form of pre and
post test surveys from 10th and 11th
grade high school students utilizing the
developed module. The findings will
provide valuable information regarding
information pertaining to the use of
interactive multimedia educational
modules in high school science
classrooms and their ability to increase
knowledge and change attitudes and
perceptions.
Frequency of Response: 4. Affected
Public: High school students engaged
with the ArchieMD: The Science of
E:\FR\FM\19MRN1.SGM
19MRN1
]]>Agencies
[Federal Register Volume 74, Number 52 (Thursday, March 19, 2009)]
[Notices]
[Pages 11734-11735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6026]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-M-0535, FDA-2008-M-0547, FDA-2008-M-0536, FDA-
2008-M-0563, FDA-2008-M-0593, FDA-2008-M-0601, FDA-2008-M-0562, FDA-
2008-M-0596, FDA-2008-M-0579, FDA-2008-M-0594, FDA-2008-M-0608, FDA-
2008-M-0645, FDA-2008-M-0646]
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 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, 2008, through December 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.
[[Page 11735]]
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From October 1, 2008, through December 31, 2008.
------------------------------------------------------------------------
PMA No./Docket Approval
No. Applicant TRADE NAME Date
------------------------------------------------------------------------
P070015 Abbott XIENCE V EVEROLIMUS ELUTING July 2,
FDA-2008-M-053 Vascular Inc. CORONARY STENT SYSTEM & 2008
5 PROMUS ELUTING CORONARY
STENT SYSTEM
------------------------------------------------------------------------
P030025 (S28) Boston TAXUS EXPRESS2 PACLITAXEL September
FDA-2008-M-054 Scientific ELUTING CORONARY STENT 24, 2008
7 Corp. SYSTEM
------------------------------------------------------------------------
P080004 Hoya Surgical HOYA ISPHERIC MODEL YA-60BB September
FDA-2008-M-053 Optics, Inc. INTRAOCULAR LENS 26, 2008
6
------------------------------------------------------------------------
H070004 Levitronix, LEVITRONIX CENTRIMAG RIGHT October 7,
FDA-2008-M-056 LLC VENTRICULAR ASSIST SYSTEM 2008
3 (RVAS)
------------------------------------------------------------------------
P060008 Boston TAXUS LIBERTE' PACLITAXEL October 10,
FDA-2008-M-059 Scientific ELUTING CORONARY STENT 2008
3 Corp. SYSTEM
------------------------------------------------------------------------
P050029 Stereotaxis, HELIOS II ABLATION CATHETER October 10,
FDA-2008-M-060 Inc. 2008
1
------------------------------------------------------------------------
H040004 Medtronic INFUSE/MASTERGRAFT October 10,
FDA-2008-M-056 Sofamor Danek POSTEROLATERAL REVISION 2008
2 USA, Inc. DEVICE
------------------------------------------------------------------------
P050019 Boston CAROTID WALLSTENT MONORAIL October 23,
FDA-2008-M-059 Scientific ENDOPROSTHESIS 2008
6 Corp.
------------------------------------------------------------------------
H060002 Spiration, IBV VALVE SYSTEM October 24,
FDA-2008-M-057 Inc. 2008
9
------------------------------------------------------------------------
P060025 ATS Medical, ATS 3F AORTIC BIOPROSTHESIS October 30,
FDA-2008-M-059 Inc. 2008
4
------------------------------------------------------------------------
P080011 Coopervision BIOFINITY COMFILCON A November
FDA-2008-M-060 Manufacturing (EXTENDED WEAR SOFT 19, 2008
8 , Ltd. CONTACT LENSES)
------------------------------------------------------------------------
P080007 Bard BARD E-LUMINEXX VASCULAR December 4,
FDA-2008-M-064 Peripheral STENT 2008
5 Vascular Inc.
------------------------------------------------------------------------
P060006 Boston BOSTON SCIENTIFIC EXPRESS December
FDA-2008-M-064 Scientific SD RENAL MONORAIL 11, 2008
6 Corp. PREMOUNTED STENT SYSTEM
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-6026 Filed 3-18-09; 8:45 am]
BILLING CODE 4160-01-S
