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9658 Federal Register / Vol. 70, No.

38 / Monday, February 28, 2005 / Notices

Notice of this meeting is given under meeting on the Internet at http:// proposed projects being developed for
the Federal Advisory Committee Act (5 www.fda.gov/cdrh/panelmtg.html. submission to OMB under the
U.S.C. app. 2). Procedure: Interested persons may Paperwork Reduction Act of 1995. To
Dated: February 17, 2005. present data, information, or views, request more information on the
orally or in writing, on issues pending proposed project or to obtain a copy of
Sheila Dearybury Walcoff,
before the committee. Written the data collection plans and draft
Associate Commissioner for External
submissions may be made to the contact instruments, call the HRSA Reports
Relations.
person by March 5, 2005. Oral Clearance Officer at (301) 443–1891.
[FR Doc. 05–3741 Filed 2–25–05; 8:45 am]
presentations from the public will be Comments are invited on: (a) Whether
BILLING CODE 4160–01–S
scheduled for approximately 30 minutes the proposed collection of information
at the beginning of committee is necessary for the proper performance
deliberations and for approximately 30 of the functions of the agency, including
DEPARTMENT OF HEALTH AND
minutes near the end of the whether the information shall have
HUMAN SERVICES
deliberations. Time allotted for each practical utility; (b) the accuracy of the
Food and Drug Administration presentation may be limited. Those agency’s estimate of the burden of the
desiring to make formal oral proposed collection of information; (c)
Circulatory System Devices Panel of presentations should notify the contact ways to enhance the quality, utility, and
the Medical Devices Advisory person before March 5, 2005, and clarity of the information to be
Committee; Notice of Meeting submit a brief statement of the general collected; and (d) ways to minimize the
nature of the evidence or arguments burden of the collection of information
AGENCY: Food and Drug Administration, they wish to present, the names and on respondents, including through the
HHS. addresses of proposed participants, and use of automated collection techniques
ACTION: Notice. an indication of the approximate time or other forms of information
requested to make their presentation. technology.
This notice announces a forthcoming Persons attending FDA’s advisory
meeting of a public advisory committee committee meetings are advised that the Proposed Project: Evaluation of the
of the Food and Drug Administration agency is not responsible for providing Implementation and Outcomes of the
(FDA). The meeting will be open to the access to electrical outlets. Maternal and Child Health Bureau’s
public. FDA welcomes the attendance of the National Healthy Start Program—Phase
Name of Committee: Circulatory public at its advisory committee II (NEW)
System Devices Panel of the Medical meetings and will make every effort to
Devices Advisory Committee. The Health Resources and Service
accommodate persons with physical Administration’s Maternal and Child
General Function of the Committee: disabilities or special needs. If you
To provide advice and Health Bureau (MCHB) initiated the
require special accommodations due to Healthy Start Program in 1991 in
recommendations to the agency on a disability, please contact Shirley
FDA’s regulatory issues. response to concerns about high infant
Meeks at 240–276–0450, ext. 105, at mortality rates. The Phase II evaluation
Date and Time: The meeting will be least 7 days in advance of the meeting.
held on March 17, 2005, from 8 a.m. to includes a survey of Healthy Start
Notice of this meeting is given under Program participants designed to collect
4 p.m. the Federal Advisory Committee Act (5
Location: Hilton Washington DC information that is important to
U.S.C. app. 2). understanding the implementation of
North/Gaithersburg, Crystals Ballroom,
620 Perry Pkwy., Gaithersburg, MD. Dated: February 17, 2005. Healthy Start and the program effects
Contact Person: Geretta Wood, Center Sheila Dearybury Walcoff, from a client perspective. Specifically,
for Devices and Radiological Health Associate Commissioner for External the goals of the survey are to: describe
(HFZ–450), Food and Drug Relations. the participant population, assess the
Administration, 9200 Corporate Blvd., [FR Doc. 05–3742 Filed 2–25–05; 8:45 am] services they received during the
Rockville, MD 20850, 301–443–8320, BILLING CODE 4160–01–S prenatal and early postpartum periods,
ext. 143, or FDA Advisory Committee describe their experiences and
Information Line, 1–800–741–8138 satisfaction with the health system and
(301–443–0572 in the Washington, DC DEPARTMENT OF HEALTH AND services, and examine their health
area), code 3014512625. Please call the HUMAN SERVICES behaviors.
Information Line for up-to-date The survey will be administered to
information on this meeting. Health Resources and Services participants at eight grantee sites. The
Agenda: The committee will discuss Administration survey will use a mixed-mode approach:
and make recommendations regarding a it will be conducted primarily by
Agency Information Collection telephone using computer-assisted
premarket notification submission for Activities: Proposed Collection;
use in the induction, maintenance, and telephone interviewing (CATI) with in-
Comment Request person field follow up if the telephone
reversal of mild hypothermia in the
treatment of unconscious adult patients In compliance with the requirement attempts are unsuccessful.
with spontaneous circulation after out- for opportunity for public comment on Data gathered from the survey will be
of-hospital cardiac arrest when the proposed data collection projects used to provide HRSA the information
initial rhythm was ventricular (section 3506(c)(2)(A) of Title 44, United necessary to assess the grantees’
fibrillation. States Code, as amended by the achievement of MCHB’s goal to improve
Background information for the topic, Paperwork Reduction Act of 1995, Pub. perinatal outcomes among racial and
including the agenda and questions for L. 104–13), the Health Resources and ethnic minorities.
the committee, will be available to the Services Administration (HRSA) The estimated burden on respondents
public one business day before the publishes periodic summaries of is as follows:

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