National Center for Injury Prevention and Control, Initial Review Group, (NCIPC, IRG), 19097 [E9-9503]
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Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘shall,’’ ‘‘must,’’
‘‘require,’’ or ‘‘requirement,’’ unless
FDA is using these words to describe a
statutory or regulatory requirement. The
guidance represents agency’s current
thinking on the topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of applicable statutes and
regulations.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
sections 1–5 of the guidance have been
approved under OMB control no. 0910–
0032 (expiration date April 30, 2010).
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
VI. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cvm or https://
www.regulations.gov.
Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9521 Filed 4–24–09; 8:45 am]
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Times and Dates:
8 a.m.–8:15 a.m., April 27, 2009 (Open).
8:15 a.m.–4 p.m., April 27, 2009 (Closed).
Place: Teleconference, Toll Free Number:
(877) 468–4185, Participant Pass code: 447–
5689.
Status: Portions of the meetings will be
closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and
(6), Title 5, U.S.C., and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Section
10(d) of Public Law 92–463.
Purpose: This group is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services, and the Director, CDC, concerning
the scientific and technical merit of grant and
cooperative agreement applications received
from academic institutions and other public
and private profit and nonprofit
organizations, including State and local
government agencies, to conduct specific
injury research that focuses on prevention
and control.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications submitted in
response to Fiscal Year 2009 Requests for
Applications related to the following
individual research announcement: CE09–
009, Youth Violence Prevention through
Economic, Environmental, and Policy
Change (U01).
Agenda items are subject to change as
priorities dictate.
Due to programmatic issues that had to be
resolved, the Federal Register notice is being
published less than fifteen days before the
date of the meeting.
Contact Person for More Information: Lisa
T. Garbarino, B.S., NCIPC, Extramural
Research Program Office, CDC, 4770 Buford
Highway, NE., M/S F62, Atlanta, Georgia
30341–3724, Telephone: (404) 723–1527.
The Director, Management Analysis and
Services Office has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 21, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–9503 Filed 4–24–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
pwalker on PROD1PC71 with NOTICES
(Pub. L. 92–463), CDC announces the
following meeting of the
aforementioned review group:
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National Center for Injury Prevention
and Control, Initial Review Group,
(NCIPC, IRG)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Computational Modeling for
Cardiovascular Devices; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Computational Modeling for
Cardiovascular Devices.’’ FDA is cosponsoring the conference with the
National Heart, Blood and Lung
Institute of the National Institutes of
Health and the National Science
Foundation. The purpose of the public
workshop is to facilitate discussion
among FDA and other interested parties
on the use of computational modeling in
the design, development, and evaluation
of cardiovascular medical devices.
Date and Time: The public workshop
will be held on June 1 and 2, 2009, from
8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Hilton Washington DC/
Rockville Executive Meeting Center,
1750 Rockville Pike, Rockville, MD
20852.
Contact Person: Donna R. Lochner,
Center for Devices and Radiological
Health (HFZ–450), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–4043, email: donna.lochner@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public
Workshop?
The purpose of the public workshop
is to facilitate discussion among FDA
and other interested parties on the use
of computational modeling in
cardiovascular device design,
development, and evaluation.
II. What Are the Topics We Intend to
Address at the Public Workshop?
We hope to discuss a large number of
issues at the public workshop,
including, but not limited to:
• Multi-scale modeling.
• Imaging for cardiovascular device
modeling.
• Physiologic input data for
cardiovascular device modeling.
• Device-specific issues related to
modeling, including a focus on heart
valves, drug-eluting and bare metal
stents, endovascular stents, cardiac
rhythm management, and mechanical
and circulatory support devices.
E:\FR\FM\27APN1.SGM
27APN1
Agencies
[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Notices]
[Page 19097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9503]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Center for Injury Prevention and Control, Initial Review
Group, (NCIPC, IRG)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), CDC announces the following meeting of
the aforementioned review group:
Times and Dates:
8 a.m.-8:15 a.m., April 27, 2009 (Open).
8:15 a.m.-4 p.m., April 27, 2009 (Closed).
Place: Teleconference, Toll Free Number: (877) 468-4185,
Participant Pass code: 447-5689.
Status: Portions of the meetings will be closed to the public in
accordance with provisions set forth in Section 552b(c)(4) and (6),
Title 5, U.S.C., and the Determination of the Director, Management
Analysis and Services Office, CDC, pursuant to Section 10(d) of
Public Law 92-463.
Purpose: This group is charged with providing advice and
guidance to the Secretary, Department of Health and Human Services,
and the Director, CDC, concerning the scientific and technical merit
of grant and cooperative agreement applications received from
academic institutions and other public and private profit and
nonprofit organizations, including State and local government
agencies, to conduct specific injury research that focuses on
prevention and control.
Matters To Be Discussed: The meeting will include the review,
discussion, and evaluation of applications submitted in response to
Fiscal Year 2009 Requests for Applications related to the following
individual research announcement: CE09-009, Youth Violence
Prevention through Economic, Environmental, and Policy Change (U01).
Agenda items are subject to change as priorities dictate.
Due to programmatic issues that had to be resolved, the Federal
Register notice is being published less than fifteen days before the
date of the meeting.
Contact Person for More Information: Lisa T. Garbarino, B.S.,
NCIPC, Extramural Research Program Office, CDC, 4770 Buford Highway,
NE., M/S F62, Atlanta, Georgia 30341-3724, Telephone: (404) 723-
1527.
The Director, Management Analysis and Services Office has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities for both CDC and the Agency for Toxic Substances and
Disease Registry.
Dated: April 21, 2009.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E9-9503 Filed 4-24-09; 8:45 am]
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