Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 3863-3865 [E7-1199]
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Federal Register / Vol. 72, No. 17 / Friday, January 26, 2007 / Notices
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Adoption of the FDA Food Code by
Local, State, and Tribal Governments
(OMB Control Number 0910–0448)—
Extension
FDA has developed its model Food
Code to assist and promote consistent
implementation of national food safety
regulatory policy among the local, State,
and tribal governmental agencies that
have primary responsibility for the
regulation or oversight of retail level
food operations. The FDA Food Code
provides a scientifically sound technical
and legal basis for regulating the retail
segment of the food industry. Authority
for providing such assistance is derived
from section 311(a) of the Public Health
Service Act (42 U.S.C. 243(a)). Under 31
U.S.C. 1535, FDA provides assistance to
other Federal agencies such as the
Indian Health Service.
Nationwide adoption of the model
FDA Food Code is an important step
toward the agency’s goal for consistent,
scientifically sound, and risk-based food
safety standards and practices. A
current, comprehensive, and accurate
inventory of food code adoptions by
States and U.S. territories, local, and
tribal governments is necessary to
determine the status of up-to-date
protection of the U.S. population and to
identify areas where assistance to these
governments may promote the adoption
of regulations based on the FDA Food
Code.
This collection effort, which began in
2001, has had remarkable success with
97 percent participation from State and
territorial governmental agencies. FDA
contracted with the Association of Food
and Drug Officials (AFDO) to conduct
the initial survey using the OMB
approved survey form. The rulemaking
process that local, State, territorial, and
tribal governmental agencies must
follow to adopt the model FDA Food
Code is often a long and complicated
process that can extend for several
years. For this reason, many agencies
have reported that they are still in the
rulemaking process to adopt or update
their food codes. Thus, FDA believes
that extension of OMB approval of the
survey is needed in order to keep the
current database accurate and up-todate. AFDO will collect the information
electronically and/or telephonically and
will be able to provide respondents with
previous survey responses already in
the database.
Description of Respondents: States
and U.S. territories, local, and tribal
governmental agencies.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Food Code Survey
Respondents
1There
75
Total Annual Responses
4
Hours per Response
300
Total Hours
1
300
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA’s
experience and the number of updates
received in the past 3 years. FDA has
reduced the estimated number of annual
respondents from 150 to 75. FDA
estimates that 75 respondents will
provide four quarterly updates each,
resulting in an estimated 300 total
annual responses. The agency estimates
that each quarterly update will take
about 1 hour. Of the 75 respondents,
those who amend their regulations with
changes unrelated to the risk factors and
interventions, and those who are not
adopting model FDA Food Code
provisions, but are incorporating certain
Conference for Food Protection
recommendations only, will likely need
only annual contact.
Dated: January 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1231 Filed 1–25–07; 8:45 am]
BILLING CODE 4160–01–S
sroberts on PROD1PC70 with NOTICES
Annual Frequency per
Response
No. of Respondents
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17:19 Jan 25, 2007
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M–0339, 2006M–0338,
2006M–0340, 2006M–0323, 2006M–0324,
2006M–0321, 2006M–0389, 2006M–0293,
2006M–0294, 2006M–0295, 2006M–0325,
2006M–0322, 2006M–0367, 2006M–0374,
2006M–0342, 2006M–0341, 2006M–0343,
2006M–0368]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
Frm 00085
Fmt 4703
FOR FURTHER INFORMATION CONTACT:
Thinh Nguyen, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4010, ext. 152.
SUPPLEMENTARY INFORMATION:
I. Background
Notice.
SUMMARY:
PO 00000
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.
Sfmt 4703
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
E:\FR\FM\26JAN1.SGM
26JAN1
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Federal Register / Vol. 72, No. 17 / Friday, January 26, 2007 / Notices
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 July 1, 2006, through
September 30, 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 JULY 1,
2006, THROUGH SEPTEMBER 30, 2006
Applicant
Trade Name
P030019/2006M–0339
Anika Therapeutics, Inc.
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
February 4, 2004
P010029/2006M–0338
Ferring Pharmaceuticals,
Inc./applicant at approval
was Savient Pharmaceuticals, Inc.
NUFLEXXA (1% SODIUM HYALURONATE)
December 3, 2004
P030016/2006M–0340
Staar Surgical Co.
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
December 22, 2005
P970043(S20)/2006M–0323
Alcon Laboratories, Inc.
LADARVISION 4000 EXCIMER LASER SYSTEM
May 1, 2006
P970043(S22)/2006M–0324
Alcon Laboratories, Inc.
LADARVISION 4000 EXCIMER LASER SYSTEM
May 2, 2006
P050051/2006M–0321
Abbott Laboratories, Inc.
ABBOTT ARCHITECT AUSA-B
June 1, 2006
P050042/2006M–0389
Abbott Laboratories, Inc.
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV
CALIBRATOR; AND ARCHITECT ANTI-HCV CONTROL
June 7, 2006
P050044/2006M–0293
Orthovita, Inc.
VITAGEL SURGICAL HEMOSTAT
June 16, 2006
P050017/2006M–0294
Cook Incorporated
ZILVER VASCULAR STENT
June 26, 2006
P050014/2006M–0295
Fujifilm Medical System
USA, Inc.
FUJI’S COMPUTED RADIOGRAPHY MAMMOGRAPHY
SUITE (FCRMS)
July 10, 2006
P020050(S4)/2006M–0325
Wavelight AG/applicant
at approval was
SurgiVision Regulatory
Consultants, Inc.
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER
SYSTEM
July 26, 2006
P050011/2006M–0322
Baxter Healthcare Corp./
applicant at approval
was Innovata PLC
ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION
July 28, 2006
P050023/2006M–0367
Biotronik, Inc.
TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT
STEROID PACING LEAD
August 10, 2006
P040036/2006M–0374
Biosense Webster, Inc.
NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC
ABLATION CATHETER
August 11, 2006
P060004/2006M–0342
Carl Zeiss, Inc./applicant
at approval was Carl
Zeiss Meditec, Inc.
MEL 80 EXCIMER LASER
August 11, 2006
P050006/2006M–0341
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PMA No./Docket No.
WL Gore & Associates,
Inc.
GORE HELEX SEPTAL OCCLUDER
August 11, 2006
P050010/2006M–0343
Synthes Spine/applicant
at approval was Synthes
Spine Co., L.P.
PRODISC-L TOTAL DISC REPLACEMENT
August 14, 2006
H040006/2006M–0368
Abiomed, Inc.
ABICOR IMPLANTABLE REPLACEMENT HEART
September 5, 2006
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Approval Date
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Federal Register / Vol. 72, No. 17 / Friday, January 26, 2007 / Notices
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301)–443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Dated: January 16, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–1199 Filed 1–25–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Proposed Project: Application for the
National Health Service Corps (NHSC)
Scholarship Program (OMB No. 0915–
0146): Extension
The National Health Service Corps
(NHSC) Scholarship Program’s mission
is to ensure the geographic
representation of physicians and other
health practitioners in the United States.
Under this program, health professions
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
Application ..........................................................................
Interview .............................................................................
Total ............................................................................
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
Karen Matsuoka, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503.
Dated: January 19, 2007.
Caroline Lewis,
Acting Associate Administrator for
Administration and Financial Management.
[FR Doc. E7–1272 Filed 1–25–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
sroberts on PROD1PC70 with NOTICES
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506 (c)(2)(A) of Title 44,
United States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
VerDate Aug<31>2005
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Responses
per
respondent
Number of
respondents
Form
Jkt 211001
1800
600
1800
Proposed Project: National Bioterrorism
Hospital Preparedness Program
(NBHPR) Data Collection Instrument
(DCI)—NEW
The Healthcare Systems Bureau
(HSB), Division of Healthcare
Preparedness (DHP), is proposing a Data
Collection Instrument (DCI) to gather
critical information from the 62
PO 00000
Frm 00087
Fmt 4703
students are offered scholarships in
return for service in a federally
designated Health Professional Shortage
Area (HPSA). The Scholarship Program
provides the NHSC with the health
professionals it requires to carry out its
mission of providing primary health
care to HPSA populations in areas of
greatest need. Students are supported
who are well qualified to participate in
the NHSC Scholarship Program and
who want to assist the NHSC in its
mission, both during and after their
period of obligated service. Scholars are
selected for these competitive awards
based on the information provided in
the application. Awards are made to
applicants who demonstrate a high
potential for providing quality primary
health care services.
The estimated response burden is as
follows:
Total
responses
1
1
........................
of proposed projects being developed
for submission to the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
To request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on (301) 443–1129.
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.
Sfmt 4703
3865
1800
600
2400
Hours per
response
1
.25
..........................
Total
burden
hours
1800
150
1950
Awardees participating in the National
Bioterrorism Hospital Preparedness
Program (NBHPR).
The DCI will capture information
related to: Performance measures,
critical benchmarks, minimal levels of
readiness, program statistics, policies
and procedures, surge capacity
elements, surge capacity as measured by
exercises, and other pertinent
information for programmatic
improvement and tracking performance.
The data will be gathered from mid-year
progress reports on annual activities,
final reports on annual activities, and
progress indicator reports submitted to
HRSA’s HSB, DHP.
Awardees will indicate the progress
made toward each of the financial and
programmatic objectives noted on their
cooperative agreement application
(CAA) on the mid-year progress report.
The final report on annual activities will
require Awardees to provide additional
details on how objectives were achieved
and how the program funds were spent.
The progress indicator report will
require Awardees to outline
improvements made to date toward
achieving the program’s critical
benchmarks.
Currently, there is no uniform
reporting system in place to capture
mid-year, final, and indicator reporting
data. A uniform system for data
E:\FR\FM\26JAN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 17 (Friday, January 26, 2007)]
[Notices]
[Pages 3863-3865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1199]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M-0339, 2006M-0338, 2006M-0340, 2006M-0323, 2006M-
0324, 2006M-0321, 2006M-0389, 2006M-0293, 2006M-0294, 2006M-0295,
2006M-0325, 2006M-0322, 2006M-0367, 2006M-0374, 2006M-0342, 2006M-0341,
2006M-0343, 2006M-0368]
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, 240-276-4010, 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 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
[[Page 3864]]
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 July 1, 2006, through September 30,
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 July 1, 2006, through September 30, 2006
------------------------------------------------------------------------
PMA No./Docket Approval
No. Applicant Trade Name Date
------------------------------------------------------------------------
P030019/2006M- Anika ORTHOVISC HIGH MOLECULAR February 4,
0339 Therapeutics, WEIGHT HYALURONAN 2004
Inc.
------------------------------------------------------------------------
P010029/2006M- Ferring NUFLEXXA (1% SODIUM December 3,
0338 Pharmaceutica HYALURONATE) 2004
ls, Inc./
applicant at
approval was
Savient
Pharmaceutica
ls, Inc.
------------------------------------------------------------------------
P030016/2006M- Staar Surgical VISIAN ICL (IMPLANTABLE December 22,
0340 Co. COLLAMER LENS) 2005
------------------------------------------------------------------------
P970043(S20)/ Alcon LADARVISION 4000 EXCIMER May 1, 2006
2006M-0323 Laboratories, LASER SYSTEM
Inc.
------------------------------------------------------------------------
P970043(S22)/ Alcon LADARVISION 4000 EXCIMER May 2, 2006
2006M-0324 Laboratories, LASER SYSTEM
Inc.
------------------------------------------------------------------------
P050051/2006M- Abbott ABBOTT ARCHITECT AUSA-B June 1, 2006
0321 Laboratories,
Inc.
------------------------------------------------------------------------
P050042/2006M- Abbott ARCHITECT ANTI-HCV ASSAY; June 7, 2006
0389 Laboratories, ARCHITECT ANTI-HCV
Inc. CALIBRATOR; AND
ARCHITECT ANTI-HCV
CONTROL
------------------------------------------------------------------------
P050044/2006M- Orthovita, VITAGEL SURGICAL HEMOSTAT June 16,
0293 Inc. 2006
------------------------------------------------------------------------
P050017/2006M- Cook ZILVER VASCULAR STENT June 26,
0294 Incorporated 2006
------------------------------------------------------------------------
P050014/2006M- Fujifilm FUJI'S COMPUTED July 10,
0295 Medical RADIOGRAPHY MAMMOGRAPHY 2006
System USA, SUITE (FCRMS)
Inc.
------------------------------------------------------------------------
P020050(S4)/ Wavelight AG/ WAVELIGHT ALLEGRETTO WAVE July 26,
2006M-0325 applicant at EXCIMER LASER SYSTEM 2006
approval was
SurgiVision
Regulatory
Consultants,
Inc.
------------------------------------------------------------------------
P050011/2006M- Baxter ADEPT (4% ICODEXTRIN) July 28,
0322 Healthcare ADHESION REDUCTION 2006
Corp./ SOLUTION
applicant at
approval was
Innovata PLC
------------------------------------------------------------------------
P050023/2006M- Biotronik, TUPOS LV/ATX & KRONOS LV- August 10,
0367 Inc. T CRT-D & COROX OWT 2006
STEROID PACING LEAD
------------------------------------------------------------------------
P040036/2006M- Biosense NAVISTAR THERMOCOOL August 11,
0374 Webster, Inc. DEFLECTABLE DIAGNOSTIC 2006
ABLATION CATHETER
------------------------------------------------------------------------
P060004/2006M- Carl Zeiss, MEL 80 EXCIMER LASER August 11,
0342 Inc./ 2006
applicant at
approval was
Carl Zeiss
Meditec, Inc.
------------------------------------------------------------------------
P050006/2006M- WL Gore & GORE HELEX SEPTAL August 11,
0341 Associates, OCCLUDER 2006
Inc.
------------------------------------------------------------------------
P050010/2006M- Synthes Spine/ PRODISC-L TOTAL DISC August 14,
0343 applicant at REPLACEMENT 2006
approval was
Synthes Spine
Co., L.P.
------------------------------------------------------------------------
H040006/2006M- Abiomed, Inc. ABICOR IMPLANTABLE September 5,
0368 REPLACEMENT HEART 2006
------------------------------------------------------------------------
[[Page 3865]]
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: January 16, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-1199 Filed 1-25-07; 8:45 am]
BILLING CODE 4160-01-S
