Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 24605 [05-9296]
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24605
Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Number of
Respondents
Activity
Pretest
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
30
30
0.167
5
4,000
Experiment
1
1
4,000
0.167
668
Total
893
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here.
Dated: May 4, 2005.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9328 Filed 5–9–05; 8:45 am]
BILLING CODE 4160–01–S
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 June 17, 2005, from 8:30 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
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 hear a
presentation on the FDA Critical Path
Initiative and a presentation by the
VerDate jul<14>2003
16:17 May 09, 2005
Jkt 205001
Office of Surveillance and Biometrics in
the Center for Devices and Radiological
Health outlining their responsibility for
the review of postmarket study design.
The committee will also hear an update
on the status of recent devices brought
before the committee. Subsequently, the
committee will discuss, make
recommendations, and vote on a
premarket approval application for a
selective head cooling system intended
for use in infants 36 weeks of gestation
or older at risk for moderate to severe
hypoxic-ischemic encephalopathy (HIE)
to prevent or reduce the severity of HIE.
Background information for the topic,
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/panelmtg.html.
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 by June 3, 2005. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person by June 3, 2005, 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.
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
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
Williams at 240–276–0450, ext. 113 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: May 3, 2005.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 05–9296 Filed 5–9–05; 8:45am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pulmonary-Allergy Drugs 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: PulmonaryAllergy Drugs 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 July 13 and 14, 2005, from 8
a.m. to 5:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Teresa A. Watkins,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, e-mail: watkinst@cder.fda.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512545. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On July 13, 2005, the
committee will discuss the implications
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Page 24605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9296]
-----------------------------------------------------------------------
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 June 17, 2005, from 8:30
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B and
C, 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 hear a presentation on the FDA Critical
Path Initiative and a presentation by the Office of Surveillance and
Biometrics in the Center for Devices and Radiological Health outlining
their responsibility for the review of postmarket study design. The
committee will also hear an update on the status of recent devices
brought before the committee. Subsequently, the committee will discuss,
make recommendations, and vote on a premarket approval application for
a selective head cooling system intended for use in infants 36 weeks of
gestation or older at risk for moderate to severe hypoxic-ischemic
encephalopathy (HIE) to prevent or reduce the severity of HIE.
Background information for the topic, 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/
panelmtg.html.
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 by June 3, 2005.
Oral presentations from the public will be scheduled for approximately
30 minutes at the beginning of committee deliberations and for
approximately 30 minutes near the end of the deliberations. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person by June 3,
2005, 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.
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 at
240-276-0450, ext. 113 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: May 3, 2005.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 05-9296 Filed 5-9-05; 8:45am]
BILLING CODE 4160-01-S
