Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 9658 [05-3742]
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9658
Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Notices
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 17, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–3741 Filed 2–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Circulatory System 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: Circulatory
System 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 March 17, 2005, from 8 a.m. to
4 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Crystals Ballroom,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Geretta Wood, Center
for Devices and Radiological Health
(HFZ–450), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–443–8320,
ext. 143, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512625. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss
and make recommendations regarding a
premarket notification submission for
use in the induction, maintenance, and
reversal of mild hypothermia in the
treatment of unconscious adult patients
with spontaneous circulation after outof-hospital cardiac arrest when the
initial rhythm was ventricular
fibrillation.
Background information for the topic,
including the agenda and questions for
the committee, will be available to the
public one business day before the
VerDate jul<14>2003
16:34 Feb 25, 2005
Jkt 205001
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 March 5, 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 before March 5, 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 Shirley
Meeks at 240–276–0450, ext. 105, 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: February 17, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–3742 Filed 2–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
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, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
proposed projects being developed for
submission to 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 at (301) 443–1891.
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.
Proposed Project: Evaluation of the
Implementation and Outcomes of the
Maternal and Child Health Bureau’s
National Healthy Start Program—Phase
II (NEW)
The Health Resources and Service
Administration’s Maternal and Child
Health Bureau (MCHB) initiated the
Healthy Start Program in 1991 in
response to concerns about high infant
mortality rates. The Phase II evaluation
includes a survey of Healthy Start
Program participants designed to collect
information that is important to
understanding the implementation of
Healthy Start and the program effects
from a client perspective. Specifically,
the goals of the survey are to: describe
the participant population, assess the
services they received during the
prenatal and early postpartum periods,
describe their experiences and
satisfaction with the health system and
services, and examine their health
behaviors.
The survey will be administered to
participants at eight grantee sites. The
survey will use a mixed-mode approach:
it will be conducted primarily by
telephone using computer-assisted
telephone interviewing (CATI) with inperson field follow up if the telephone
attempts are unsuccessful.
Data gathered from the survey will be
used to provide HRSA the information
necessary to assess the grantees’
achievement of MCHB’s goal to improve
perinatal outcomes among racial and
ethnic minorities.
The estimated burden on respondents
is as follows:
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]]>Agencies
[Federal Register Volume 70, Number 38 (Monday, February 28, 2005)]
[Notices]
[Page 9658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3742]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Circulatory System 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: Circulatory System 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 March 17, 2005, from 8
a.m. to 4 p.m.
Location: Hilton Washington DC North/Gaithersburg, Crystals
Ballroom, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Geretta Wood, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-443-8320, ext. 143, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512625. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss and make recommendations
regarding a premarket notification submission for use in the induction,
maintenance, and reversal of mild hypothermia in the treatment of
unconscious adult patients with spontaneous circulation after out-of-
hospital cardiac arrest when the initial rhythm was ventricular
fibrillation.
Background information for the topic, including the agenda and
questions for the committee, will be available to the public one
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 March 5, 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 before March
5, 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 Shirley Meeks at
240-276-0450, ext. 105, 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: February 17, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-3742 Filed 2-25-05; 8:45 am]
BILLING CODE 4160-01-S
