Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 24080 [05-9008]
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24080
Federal Register / Vol. 70, No. 87 / Friday, May 6, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Gastroenterology and Urology 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: Gastroenterology
and Urology 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 8, 2005, from 9 a.m. to 5
p.m.
Location: Holiday Inn, Walker/
Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Jeffrey Cooper, Center
for Devices and Radiological Health
(HFZ–470), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–594–1220,
ext. 121, or FDA Advisory Committee
Information Hotline, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512523. 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 discuss and
make recommendations regarding
general issues related to the premarket
requirements for the safe and effective
use of hemodialysis equipment labeled
for nocturnal hemodialysis therapies.
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/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 May 25, 2005. Oral
presentations from the public will be
scheduled for approximately 30 minutes
VerDate jul<14>2003
18:03 May 05, 2005
Jkt 205001
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 May 25, 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, Conference Management
Staff, 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).
discretionary grant program established
to assist Federally-recognized Tribes
and Tribally-sanctioned Tribal
organizations in assuming all or part of
existing Indian Health Service (IHS)
programs, services, functions, and
activities (PSFA) through a Title I
contract and to assist established Title I
contractors and Title V compactors to
further develop and improve their
management capability. In addition,
TMGs are available to Tribes/Tribal
organizations under the authority of
Public Law (Pub. L.) 93–638 section
103(e) for (1) obtaining technical
assistance from providers designated by
the Tribe/Tribal organization (including
Tribes/Tribal organizations that operate
mature contracts) for the purposes of
program planning and evaluation,
including the development of any
management systems necessary for
contract management and the
development of cost allocation plans for
indirect cost rates; and (2) planning,
designing, and evaluating Federal health
programs serving the Tribe/Tribal
organization, including Federal
administrative functions. These grants
are established under the authority of
section 103(b)(2) and section 103(e) of
the Indian Self-Determination and
Dated: April 28, 2005.
Education Assistance Act, Pub. L. 93–
Sheila Dearybury Walcoff,
638, as amended.
Associate Commissioner for External
Funding Priorities: The IHS has
Relations.
established the following funding
[FR Doc. 05–9008 Filed 5–5–05; 8:45 am]
priorities for TMG awards. The funding
BILLING CODE 4160–01–S
of approved Priority I applicants will
occur before the funding of approved
Priority II applicants. Priority II
DEPARTMENT OF HEALTH AND
applicants will be funded before
HUMAN SERVICES
approved Priority III applicant. Funds
will be distributed until depleted.
Indian Health Service
• Priority I—Any Indian Tribe that
has received Federal recognition
Tribal Management Grant Program;
(restored, unterminated, funded, or
New Discretionary Funding Cycle for
unfunded) within the past 5 years,
Fiscal Year 2006
specifically received during or after
Funding Opportunity Number: HHS–
April 2000.
2006–IHS–TMP–0001.
• Priority II—All other eligible
CFDA Number: 93.228.
Federally-recognized Indian Tribes or
Key Dates: Training: May 23–27, 2005;
Tribally-sanctioned Tribal organizations
June 15–16, 2005 June 29–30, 2005; and
submitting a competing continuation
July 13–14, 2005.
application or a new application with
Application Receipt Deadline: August
the sole purpose of addressing audit
12, 2005.
Application Review Dates: October 3– material weaknesses identified in
Attachment A (Summary of Findings
7, 2005.
and Recommendations) and other
Application Notification: Second
attachments, if any, of the transmittal
week of November 2005.
Anticipated Award Start Date: January letter received from the Office of the
Inspector General (OIG), National
1, 2006.
External Audit Review (NEAR) Center,
Program Authority: Public Law 93–
Department of Health and Human
638, Sections 103(b)(2) and 103(e),
Services (HHS). Please identify by
Indian Self-Determination and
underlining the weakness to be
Education Assistance Act, as amended.
addressed on Attachment A. Please refer
I. Funding Opportunity Description
to Section III.3, ‘‘Other Requirements’’
for more information regarding Priority
The Tribal Management Grant (TMG)
II participation.
Program is a national competitive
PO 00000
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]]>Agencies
[Federal Register Volume 70, Number 87 (Friday, May 6, 2005)]
[Notices]
[Page 24080]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9008]
[[Page 24080]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Gastroenterology and Urology 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: Gastroenterology and Urology 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 8, 2005, from 9
a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Jeffrey Cooper, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-1220, ext. 121, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512523. 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 discuss and make recommendations regarding general
issues related to the premarket requirements for the safe and effective
use of hemodialysis equipment labeled for nocturnal hemodialysis
therapies. 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/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 May 25, 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 May 25,
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,
Conference Management Staff, 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: April 28, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9008 Filed 5-5-05; 8:45 am]
BILLING CODE 4160-01-S
