Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 55490-55491 [06-8114]
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55490
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section/
FDA Form
Annual
Frequency
perResponse
No. of
Respondents
Total Annual
Records
Hours per
Response
Total Capital
Costs
Total Hours
Total Operating &
Maintenance Costs
900.24(b)
1.2
1
1.2
30
36
900.24(b)(1)
0.3
1
0.3
200
60
$26
900.24(b)(3)
0.15
1
0.15
100
15
$13
900.25(a)
0.2
1
0.2
16
3.2
FDA Form 3422
700
1
700
0.25
175
Total
1 Refers
to
to
to
4 Refers to
5 Refers to
2 Refers
3 Refers
3,072,138
$40,000
$14,612,872
entities that are applying for the first time.
accreditation bodies applying to accredit specific Full Field Digital Mammography units.
the facility component of the burden for this requirement.
the accreditation body component of the burden for this requirement.
the situation where a patient specifically does not want to receive the lay summary of her exam.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Annual
Frequency of
Recordkeeping
Total Annual
Records
6
1
6
1
89
1
89
8
712
900.12(a)(4)
8,840
4
35,360
1
35,360
900.12(c)(4)
8,840
1
8,840
1
8,840
900.12(e)(13)
8,840
52
459,680
0.083
38,154
900.12(f)
8,840
1
8,840
16
141,440
900.12(h)(2)
8,840
2
17,680
1
17,680
900.22(a)
6
1
6
1
6
900.22(d)
6
1
6
1
6
900.22(e)
6
1
6
1
6
900.22(f)
3
1
3
1
3
900.22(g)
6
1
6
1
6
900.25(b)
6
1
6
1
6
Number of
Recordkeepers
900.4(g)
900.12(a)(1)(i)(B)(2)
Hours per
Recordkeeper
Total
Hours
Total
sroberts on PROD1PC70 with NOTICES
Total Operating &
Maintenance
Costs
6
CFR Section
242,225
This request for OMB approval now
serves to consolidate previously
approved information collection, OMB
Control Number 0910–0580 into 0910–
0309. The hourly burden as well as the
associated operating costs were
increased to better represent the actual
burden and costs on facilities and
accreditation bodies.
The following regulations were not
included in the above burden tables
because they were considered usual and
customary practice and were part of the
standard of care prior to the
implementation of the regulations.
VerDate Aug<31>2005
Total Capital
Costs
20:37 Sep 21, 2006
Jkt 208001
Therefore, they resulted in no additional
reporting or recordkeeping burden: 21
CFR 900.12(c)(1), 900.12(c)(3), and
900.3(f)(1).
The following regulations were not
included in the previously mentioned
burden tables because they were not
considered applicable during the
information collection period or their
burdens were reported under other
regulatory requirements. Therefore, they
resulted in no additional reporting or
recordkeeping burden: 21 CFR 900.3(c),
900.11(b)(1), 900.11(b)(2), and 900.24(c).
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$25,000
$60
$25,000
$60
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–8027 Filed 9–21–06; 8:45 am]
BILLING CODE 4160–01–S
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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Neurological
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 31, 2006, from 8 a.m.
to 6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Ballroom Salons C,
D, and E, 620 Perry Pkwy., Gaithersburg,
MD.
Contact Person: Janet L. Scudiero,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–594–1184, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512513. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will discuss
and make recommendations on a
premarket notification application for a
device intended for the treatment of
major depressive disorder. The
committee will also hear and discuss
the post approval study reports for two
recently approved neurological device
premarket approval applications.
Background information for the topics,
including the agenda and questions for
the committee, will be available to the
public 1 business day before the
meeting on the Internet at https://
www.fda.gov/cdrh/panel (click on
Upcoming CDRH Advisory Panel/
Committee Meetings).
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 17, 2006.
Oral presentations from the public will
be scheduled for 30 minutes at the
beginning of the committee
VerDate Aug<31>2005
20:37 Sep 21, 2006
Jkt 208001
deliberations and for 30 minutes near
the end of the committee deliberations.
Time allotted for each presentation may
be limited. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 17, 2006.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, at 301–827–7291, at least 7 days
in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. 06–8114 Filed 9–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2006N–0292]
Unique Device Identification; Notice of
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting and
vendor display.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting and vendor display to
discuss the issues associated with the
development, implementation, and use
of a unique device identification (UDI)
system and the use of various automatic
identification technologies. We are
inviting individuals, companies,
organizations, and other stakeholders to
attend this public meeting, which will
focus on the development and
implementation of a UDI system; the
benefits and costs of a UDI system; the
use of automatic identification
technologies; and the development,
maintenance, and use of a repository for
UDI related information. We are also
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55491
inviting vendors of automatic
identification technologies to display
their products for the educational
benefits of FDA and other attendees.
DATES AND TIMES: The public meeting
will be held on Wednesday, October 25,
2006, from 9 a.m. to 4 p.m. Registration
to attend the meeting, to present at the
meeting, and to participate in the
vendor display must be received by
October 10, 2006. Submit written
comments by November 9, 2006.
You may register electronically at
www.fda.gov/cdrh/ocd/udi/
(see SUPPLEMENTARY INFORMATION,
section V of this document for
information on registration.
ADDRESSES: The public meeting will be
held at the Gaithersburg Marriott
Washingtonian Center, 9751
Washingtonian Blvd., Gaithersburg, MD
20878, 1–301–590–0044.
A block of rooms is being held for the
evening of Tuesday, October 24, 2006.
Please mention the ‘‘FDA UDI Meeting’’
when calling the hotel.
Submit written comments 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. All comments should be
identified with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
David Racine or Jay Crowley, Center for
Devices and Radiological Health (HFZ–
500), Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850,
240–276–3400, e-mail:
CDRHUDI@fda.hhs.gov
If you need special accommodations
due to a disability, please contact Ann
Marie Williams at 301–827–7291 at least
7 days in advance of the meeting.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February
26, 2004, we published a final rule (the
‘‘bar code rule’’) (69 FR 9120) requiring
bar codes on certain human drug and
biological products to help reduce
medication errors in hospitals and other
health care settings. The bar code is
intended to enable health care
professionals to use bar code scanning
equipment in conjunction with
computerized medication
administration systems to verify that the
right drug, in the right dose, is being
given to the right patient at the right
time. This rule (now codified at 21 CFR
201.25 and 610.67) requires that
manufacturers encode the unique
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]]>Agencies
[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55490-55491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8114]
[[Page 55491]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Neurological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Neurological Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on October 31, 2006, from 8
a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Ballroom Salons
C, D, and E, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Janet L. Scudiero, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1184, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512513. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will discuss and make recommendations on a
premarket notification application for a device intended for the
treatment of major depressive disorder. The committee will also hear
and discuss the post approval study reports for two recently approved
neurological device premarket approval applications. Background
information for the topics, including the agenda and questions for the
committee, will be available to the public 1 business day before the
meeting on the Internet at https://www.fda.gov/cdrh/panel (click on
Upcoming CDRH Advisory Panel/Committee Meetings).
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 17, 2006. Oral presentations from the public will be scheduled
for 30 minutes at the beginning of the committee deliberations and for
30 minutes near the end of the committee deliberations. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before October 17, 2006.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, at 301-827-7291, at least 7 days in
advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 06-8114 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S
