Intrapartum Electronic Fetal Monitoring With Computer Assisted Diagnosis Workshop-Exploring Methods of Evaluation, 63715 [E8-25586]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 208 / Monday, October 27, 2008 / Notices
ACE, E-mail address:
Karen_T._Matsuoka@omb.eop.gov.
Dated: October 20, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–25419 Filed 10–24–08; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Intrapartum Electronic Fetal
Monitoring With Computer Assisted
Diagnosis Workshop—Exploring
Methods of Evaluation
AGENCY:
Food and Drug Administration,
HHS
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Intrapartum Electronic Fetal
Monitoring (EFM) With Computer
Assisted Diagnosis (CAD)—Exploring
Methods of Evaluation.’’ The objectives
of this workshop are to gather ideas on
how to identify and differentiate
categories of EFM/CAD devices and the
corresponding levels of evidence
needed to validate these devices.
Workshop participants will also discuss
how currently available databases might
be used to verify/validate intrapartum
EFM/CAD algorithms.
Date and Time: The workshop will be
held on November 10, 2008, from 8 a.m.
to 5 p.m. Registrations will be accepted
through October 31, 2008. Participants
are encouraged to arrive early to ensure
time for parking, security screening, and
registration before the meeting. Security
screening will begin at 7 a.m. and
registration will begin at 7:30 a.m. See
Registration Information section of this
document for registration details.
Location: The workshop will be held
at the Food & Drug Administration
White Oak Campus, conference room G–
2047, 10903 New Hampshire Ave.,
Silver Spring, MD 20993.
FDA will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please notify one of the
contacts listed in this document (see
Contact) at least 7 days in advance of
the workshop.
Contact: Sharon Andrews, Center for
Devices and Radiological Health (HFZ–
470), Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 240–276–4148, FAX: 240–276–
4156, sharon.andrews@fda.hhs.gov; or
VerDate Aug<31>2005
17:13 Oct 24, 2008
Jkt 217001
Elaine Blyskun, Center for Devices
and Radiological Health (HFZ–470),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4100, FAX: 240–276–4156,
elaine.blyskun@fda.hhs.gov.
Registration Information: Registration
may be completed online at the
following Web site: https://
www.blsmeetings.net/1368-2. There is
no registration fee for this workshop;
however, all participants must submit a
registration form. Space is limited, so
please register as soon as possible to
reserve a space. Registrations will be
accepted through (see DATES). Persons
without Internet access may contact
Syreeta Tate-Jones at 301–577–0244,
ext. 49 by October 31, 2008, to register.
Agenda: The workshop will begin
with a morning session to provide a
clinical and regulatory overview of
intrapartum fetal monitors. Presentation
topics will address fetal monitoring in
general, the relationship between
technology and clinical decisionmaking,
the current state of EFM/CAD
development, and evaluation/validation
methods that may be applied to new
EFM/CAD systems. In the afternoon,
attendees will break into two discussion
groups: (1) EFM/CAD technological
development and validation and (2) the
practicality of using existing databases
to test new EFM/CAD algorithms. The
workshop will conclude with an
overview of the break-out discussions
and identification of research gaps and
opportunities in the field.
Dated: October 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–25586 Filed 10–24–08; 8:45 am]
BILLING CODE 4160–01–S
63715
Status: The meeting will be open to the
public.
Purpose: The Advisory Committee
provides advice and recommendations on a
broad range of issues dealing with programs
and activities authorized under section 747
of the Public Health Service Act as amended
by The Health Professions Education
Partnership Act of 1998, Public Law 105–
392. At this meeting the Advisory Committee
will work on its eighth report about the redesign of the delivery of primary health care
and its implications for the training of
primary care practitioners. Reports are
submitted to Congress and to the Secretary of
the Department of Health and Human
Services.
Agenda: The meeting on Monday,
November 17, will begin with opening
comments from the Chair of the Advisory
Committee and introductory remarks from
senior management of the Health Resources
and Services Administration. The Advisory
Committee will elect a new chair and two
vice-chairs prior to the main agenda. In the
plenary session, the Advisory Committee will
discuss key elements they wish to include in
the eighth report, develop an outline for the
report, and draft report recommendations.
The work will be done in plenary session and
in small groups. On Tuesday, November 18,
the Advisory Committee will continue its
work on the eighth report and determine next
steps in the report preparation process. The
members will plan an agenda for the next
Advisory Committee meeting. An
opportunity will be provided for public
comment.
For Further Information Contact: Anyone
interested in obtaining a roster of members or
other relevant information should write or
contact Jerilyn K. Glass, M.D., PhD, Division
of Medicine and Dentistry, Bureau of Health
Professions, Health Resources and Services
Administration, Room 9A–27, Parklawn
Building, 5600 Fishers Lane, Rockville,
Maryland 20857, Telephone (301) 443–6822.
The Web address for information on the
Advisory Committee is https://bhpr.hrsa.gov/
medicine-dentistry/actpcmd.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Dated: October 21, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–25569 Filed 10–24–08; 8:45 am]
BILLING CODE 4165–15–P
Advisory Committee on Training in
Primary Care Medicine and Dentistry;
Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: Advisory Committee on Training in
Primary Care Medicine and Dentistry
(ACTPCMD).
Date and Time: November 17, 2008, 8:30
a.m.–4:30 p.m. November 18, 2008, 8 a.m.–
2 p.m.
Place: The Legacy Hotel and Meeting
Centre, 1775 Rockville Pike, Rockville,
Maryland 20852.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Nurse
Education and Practice; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: National Advisory Council on
Nurse Education and Practice (NACNEP).
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 73, Number 208 (Monday, October 27, 2008)]
[Notices]
[Page 63715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25586]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Intrapartum Electronic Fetal Monitoring With Computer Assisted
Diagnosis Workshop--Exploring Methods of Evaluation
AGENCY: Food and Drug Administration, HHS
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Intrapartum Electronic Fetal Monitoring (EFM) With
Computer Assisted Diagnosis (CAD)--Exploring Methods of Evaluation.''
The objectives of this workshop are to gather ideas on how to identify
and differentiate categories of EFM/CAD devices and the corresponding
levels of evidence needed to validate these devices. Workshop
participants will also discuss how currently available databases might
be used to verify/validate intrapartum EFM/CAD algorithms.
Date and Time: The workshop will be held on November 10, 2008, from
8 a.m. to 5 p.m. Registrations will be accepted through October 31,
2008. Participants are encouraged to arrive early to ensure time for
parking, security screening, and registration before the meeting.
Security screening will begin at 7 a.m. and registration will begin at
7:30 a.m. See Registration Information section of this document for
registration details.
Location: The workshop will be held at the Food & Drug
Administration White Oak Campus, conference room G-2047, 10903 New
Hampshire Ave., Silver Spring, MD 20993.
FDA will make every effort to accommodate persons with physical
disabilities or special needs. If you require special accommodations
due to a disability, please notify one of the contacts listed in this
document (see Contact) at least 7 days in advance of the workshop.
Contact: Sharon Andrews, Center for Devices and Radiological Health
(HFZ-470), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240-276-4148, FAX: 240-276-4156,
sharon.andrews@fda.hhs.gov; or
Elaine Blyskun, Center for Devices and Radiological Health (HFZ-
470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 240-276-4100, FAX: 240-276-4156, elaine.blyskun@fda.hhs.gov.
Registration Information: Registration may be completed online at
the following Web site: https://www.blsmeetings.net/1368-2. There is no
registration fee for this workshop; however, all participants must
submit a registration form. Space is limited, so please register as
soon as possible to reserve a space. Registrations will be accepted
through (see Dates). Persons without Internet access may contact
Syreeta Tate-Jones at 301-577-0244, ext. 49 by October 31, 2008, to
register.
Agenda: The workshop will begin with a morning session to provide a
clinical and regulatory overview of intrapartum fetal monitors.
Presentation topics will address fetal monitoring in general, the
relationship between technology and clinical decisionmaking, the
current state of EFM/CAD development, and evaluation/validation methods
that may be applied to new EFM/CAD systems. In the afternoon, attendees
will break into two discussion groups: (1) EFM/CAD technological
development and validation and (2) the practicality of using existing
databases to test new EFM/CAD algorithms. The workshop will conclude
with an overview of the break-out discussions and identification of
research gaps and opportunities in the field.
Dated: October 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25586 Filed 10-24-08; 8:45 am]
BILLING CODE 4160-01-S
