Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 41041-41043 [05-13901]
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41041
Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Notices
Number of
respondents
Instrument
Optional Submission of Data on Child Poverty from an Independent Source
Assessment of the Impact of TANF on the Increase in Child Poverty ...........
Corrective Action Plan .....................................................................................
Estimated Total Burden Hours:
15,552.
In compliance with the requirements
of Section 3506(c)(2) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, 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:
grjohnson@acf.hhs.gov.
The Department specifically requests
comments 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: July 11, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–13919 Filed 7–14–05; 8:45 am]
Food and Drug Administration
[Docket No. 2004N–0565]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
State Petitions for Exemption From
Preemption
Food and Drug Administration,
HHS.
VerDate jul<14>2003
17:47 Jul 14, 2005
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘State Petitions for Exemption From
Preemption’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857,301–827–1223.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 8, 2005 (70 FR
18029), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0277. The
approval expires on July 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: July 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–13899 Filed 7–14–05; 8:45 am]
BILLING CODE 4160–01–S
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1
1
1
8
120
160
Total burden
hours
432
6,480
8,640
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Food Canning Establishment
Registration, Process Filing, and
Recordkeeping for Acidified Foods and
Thermally Processed Low-Acid Foods
in Hermetically Sealed Containers’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 8, 2005 (70 FR
18034), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0037. The
approval expires on June 30, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: July 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–13900 Filed 7–14–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Food Canning Establishment
Registration, Process Filing, and
Recordkeeping for Acidified Foods and
Thermally Processed Low-Acid Foods
in Hermetically Sealed Containers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0032]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Average burden hours per
response
54
54
54
Food and Drug Administration
BILLING CODE 4184–01–M
AGENCY:
ACTION:
Number of responses per
respondent
[Docket Nos. 2005M–0024, 2005M–0025,
2005M–0026, 2005M–0092, 2005M–0087,
2005M–0055, 2005M–0089, 2005M–0027,
2005M–0109, 2005M–0028, 2005M–0088,
2005M–0110, 2005M–0132]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
Notice.
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41042
Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Notices
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 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.
ADDRESSES:
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 January 1, 2005, through
March 31, 2005. 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 JANUARY 1,
2005, THROUGH MARCH 31, 2005
PMA No./Docket No.
Applicant
TRADE NAME
Approval Date
P010058/2005M–0024
Medilink
OSTEOSPACE
March 15, 2004
P030029/2005M–0025
Bayer HealthCare, LLC
ADVIA CENTAUR ANTI HBs READYPACK
REAGENTS & ADVIA CENTAUR ANTI
HBs READYPACK CALIBRATORS
May 14, 2005
P030028/2005M–0026
Ophtec USA, Inc.; Ophtec
BV
ARTISAN (MODEL 206 & 204) PHAKIC
INTRAOCULAR LENS (PIOL) VERISYSE
(VRSM5US & VRMA6US) PHAKIC
INTRAOCULAR LENS
September 10, 2004
P040006/2005M–0092
DePuy Spine, Inc.
CHARITE ARTIFICIAL DISC
October 26, 2004
P030007/2005M–0087
Eastman Kodak Co.
KODAK MAMMAGRAPHY CAD ENGINE
November 23, 2004
P930016 (S17)/2005M–0055
VISX, Inc.
STAR S4 EXCIMER LASER SYSTEM
WITH VARIABLE SPOT SCANNING
(VSS) & WAVESCAN WAVEFRONT
SYSTEM
December 14, 2004
P030030/2005M–0089
Genyx Medical
URYX URETHRAL BULKING AGENT
December 16, 2004
P030022/2005M–0027
Smith & Nephew, Inc.
REFLECTION CERAMIC ACETABULAR
SYSTEM
December 17, 2004
P040004/2005M–0109
Bayer Healthcare LLC
ADVIA CENTAUR HBC TOTAL READY
PAK REAGENTS & ADVIA CENTAUR
HBC TOTAL QUALITY CONTROL MATERIALS
December 22, 2004
P030034/2005M–0028
Orthofix, Inc.
CERVICAL–STIM MODEL 505L CERVICAL
FUSION SYSTEM
December 23, 2004
P040014/2005M–0088
Irvine Biomedical, Inc.
IBI THERAPY CARDIAC ABLATION SYSTEM
January 14, 2005
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Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Notices
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2005, THROUGH MARCH 31, 2005—Continued
PMA No./Docket No.
Applicant
TRADE NAME
Approval Date
P040017/2005M–0110
Bayer Healthcare, LLC
ADVIA CENTAUR ANTI–HAV TOTAL
ASSAY & ADVIA CENTAUR TOTAL
QUALITY CONTROL MATERIALS
March 7, 2005
H030005/2005M–0132
CoAxia, Inc.
COAXIA NEUROFLO CATHETER
March 30, 2005
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: July 6, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–13901 Filed 7–14–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0195]
Draft Guidance for Industry and Food
and Drug Administration Staff; The
Mammography Quality Standards Act
Final Regulations: Modifications and
Additions to Policy Guidance Help
System #9; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘The Mammography Quality
Standards Act Final Regulations:
Modifications and Additions to Policy
Guidance Help System #9.’’ The draft
guidance document is intended to assist
facilities and their personnel in meeting
the Mammography Quality Standards
Act (MQSA) final regulations.
DATES: Submit written or electronic
comments on this draft guidance by
October 13, 2005.
ADDRESSES: Submit written requests for
single copies on a 3.5″ diskette of the
draft guidance document entitled ‘‘The
Mammography Quality Standards Act
Final Regulations: Modifications and
Additions to Policy Guidance Help
System #9’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
VerDate jul<14>2003
17:47 Jul 14, 2005
Jkt 205001
assist that office in processing your
request, or fax your request to 301–443–
8818. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this draft guidance and the information
collection provisions 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.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Charles Finder, Center for Devices and
Radiological Health (HFZ–240), Food
and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 301–594–
3332.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance is intended to
provide guidance to mammography
facilities and their personnel. It
represents the FDA’s current thinking
on various aspects of the final
regulations implementing the MQSA
(Public Law 102–539). Once finalized,
this draft guidance document will add
to and update material in the Policy
Guidance Help System (PGHS) in order
to address recurring inquiries to the
Center for Devices and Radiological
Health (CDRH) about these issues. The
PGHS is a computerized system
accessible through FDA’s Web site that
is intended to provide useful
information to mammography facilities
and their personnel on issues relating to
MQSA. The guidance only addresses
those portions of the PGHS that are
being revised.
This draft guidance addresses the
following issues:
1. Definitions of final interpretation
and lossless and lossy digital
compression;
2. Use of Small Field Digital
Mammography image receptors;
3. Clarification relating to
reestablishing processor operating
levels;
PO 00000
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4. Impact of the Health Insurance
Portability and Accountability Act
requirements on certain MQSA
activities;
5. Retention of medical outcomes
audit records;
6. Steps to take when patients do not
wish to receive their lay summaries;
7. Combining medical reports;
8. The effect of film digitization and
compression of Full Field Digital
Mammography (FFDM) digital data on
retention, transfer, and interpretation of
mammographic images;
9. Clarification of continuing
education requirements;
10. Use of foreign-trained physicians;
11. Use of the American Registry of
Radiologic Technologists ARRT(M)
certificate to meet certain radiologic
technologist requirements;
12. Quality Control testing when
using cushion pads on compression
devices;
13. Medical physicist involvement in
certain FFDM repairs;
14. Use of printers and monitors that
were not specifically approved as part of
an FFDM unit; and
15. Digitization of paper records and
personnel documents.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the issues described in the previous
paragraphs. 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 statute
and regulations.
III. Electronic Access
To receive ‘‘The Mammography
Quality Standards Act Final
Regulations: Modifications and
Additions to Policy Guidance Help
System #9’’ by fax, call the CDRH FactsOn-Demand system at 800–899–0381 or
301–827–0111 from a touch-tone
telephone. Press 1 to enter the system.
At the second voice prompt, press 1 to
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]]>Agencies
[Federal Register Volume 70, Number 135 (Friday, July 15, 2005)]
[Notices]
[Pages 41041-41043]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13901]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005M-0024, 2005M-0025, 2005M-0026, 2005M-0092, 2005M-
0087, 2005M-0055, 2005M-0089, 2005M-0027, 2005M-0109, 2005M-0028,
2005M-0088, 2005M-0110, 2005M-0132]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 41042]]
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
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 January 1, 2005, through March 31,
2005. 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 January 1, 2005, through March 31, 2005
------------------------------------------------------------------------
PMA No./Docket No. Applicant TRADE NAME Approval Date
------------------------------------------------------------------------
P010058/2005M-0024 Medilink OSTEOSPACE March 15,
2004
------------------------------------------------------------------------
P030029/2005M-0025 Bayer ADVIA CENTAUR ANTI May 14, 2005
HealthCare, HBs READYPACK
LLC REAGENTS & ADVIA
CENTAUR ANTI HBs
READYPACK
CALIBRATORS
------------------------------------------------------------------------
P030028/2005M-0026 Ophtec USA, ARTISAN (MODEL 206 & September 10,
Inc.; Ophtec 204) PHAKIC 2004
BV INTRAOCULAR LENS
(PIOL) VERISYSE
(VRSM5US & VRMA6US)
PHAKIC INTRAOCULAR
LENS
------------------------------------------------------------------------
P040006/2005M-0092 DePuy Spine, CHARITE ARTIFICIAL October 26,
Inc. DISC 2004
------------------------------------------------------------------------
P030007/2005M-0087 Eastman Kodak KODAK MAMMAGRAPHY November 23,
Co. CAD ENGINE 2004
------------------------------------------------------------------------
P930016 (S17)/ VISX, Inc. STAR S4 EXCIMER December 14,
2005M-0055 LASER SYSTEM WITH 2004
VARIABLE SPOT
SCANNING (VSS) &
WAVESCAN WAVEFRONT
SYSTEM
------------------------------------------------------------------------
P030030/2005M-0089 Genyx Medical URYX URETHRAL December 16,
BULKING AGENT 2004
------------------------------------------------------------------------
P030022/2005M-0027 Smith & Nephew, REFLECTION CERAMIC December 17,
Inc. ACETABULAR SYSTEM 2004
------------------------------------------------------------------------
P040004/2005M-0109 Bayer ADVIA CENTAUR HBC December 22,
Healthcare LLC TOTAL READY PAK 2004
REAGENTS & ADVIA
CENTAUR HBC TOTAL
QUALITY CONTROL
MATERIALS
------------------------------------------------------------------------
P030034/2005M-0028 Orthofix, Inc. CERVICAL-STIM MODEL December 23,
505L CERVICAL 2004
FUSION SYSTEM
------------------------------------------------------------------------
P040014/2005M-0088 Irvine IBI THERAPY CARDIAC January 14,
Biomedical, ABLATION SYSTEM 2005
Inc.
------------------------------------------------------------------------
[[Page 41043]]
P040017/2005M-0110 Bayer ADVIA CENTAUR ANTI- March 7, 2005
Healthcare, HAV TOTAL ASSAY &
LLC ADVIA CENTAUR TOTAL
QUALITY CONTROL
MATERIALS
------------------------------------------------------------------------
H030005/2005M-0132 CoAxia, Inc. COAXIA NEUROFLO March 30,
CATHETER 2005
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: July 6, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-13901 Filed 7-14-05; 8:45 am]
BILLING CODE 4160-01-S
