Food and Drug Administration/National Heart Lung and Blood Institute/National Science Foundation Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models; Public Workshop, 18849 [2010-8311]

Download as PDF Federal Register / Vol. 75, No. 70 / Tuesday, April 13, 2010 / Notices Office, 4770 Buford Highway, NE., Mailstop K–92, Atlanta, GA 30341, Telephone: (770) 488–3023, E-mail: DYB7@cdc.gov. 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 5, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–8442 Filed 4–12–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Food and Drug Administration/National Heart Lung and Blood Institute/ National Science Foundation Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models; Public Workshop AGENCY: Food and Drug Administration, HHS. sroberts on DSKD5P82C1PROD with NOTICES ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘FDA/NHLBI/ NSF Workshop on Computer Methods for Cardiovascular Devices: The Integration of Nonclinical and Clinical Models.’’ The workshop will include a smaller, optional session entitled ‘‘Microstructure Modeling Session.’’ FDA is cosponsoring the workshop with the National Heart Lung and Blood Institute of the National Institutes of Health and the National Science Foundation. The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices. Dates and Times: The optional session will be held on June 9, 2010, from 1 p.m. to 5:30 p.m. and the public workshop will be held on June 10 and 11, 2010, from 8 a.m. to 5 p.m. Location: The public workshop and optional session 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, Food and Drug Administration, VerDate Nov<24>2008 17:33 Apr 12, 2010 Jkt 220001 10903 New Hampshire Ave., Bldg. 66, rm. 1110, Silver Spring, MD 20993, 301–796–6309, donna.lochner@fda.hhs.gov. Registration: To register for the public workshop and optional session, please visit the following Web site: https:// scpd.stanford.edu/ publicViewHome.do?method=load. There is a registration fee to attend the public workshop to cover the expenses and attendees must register in advance. The fee for the meeting is $350. Students will be offered a discounted fee of $175. The exhibitors’ fee is $600 and includes registration of one person. Fees will be waived for invited speakers and the organizing committee. The registration process will be handled by the Stanford Center for Professional Development. Although the facility is spacious, registration will be on a firstcome, first-served basis. If you need special accommodations because of a disability, please contact Donna R. Lochner at least 7 days before the public workshop. SUPPLEMENTARY INFORMATION: I. Why Are We Holding This Public Workshop? The purpose of the public workshop is to facilitate discussion between 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, with our overall theme being the integration of computer and nonclinical models. Topics include, but are not limited to the following: • Multiscale, multiphysics, and multiphase modeling; • Modeling of cardiovascular diseases and therapies; • Patient-specific modeling, including virtual surgical planning and predictive biomedicine; • Open source projects, including public policy initiatives, database development and data presentation, and standards and protocols; and • Regulatory issues with implementation of computer modeling. III. Where Can I Find Out More About This Public Workshop? Background information on the public workshop, registration information, the agenda, information about lodging, and other relevant information will be posted, as it becomes available, on the Internet at https://www.fda.gov/ PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 18849 MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm Dated: April 7, 2010. Jeffrey Shuren, Director, Center for Devices and Radiological Health. [FR Doc. 2010–8311 Filed 4–12–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0183] Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation—Small Entity Compliance Guide.’’ The small entity compliance guide (SECG) is being issued for a final rule published in the Federal Register of July 9, 2009, and is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation. Elsewhere in this issue of the Federal Register, FDA is amending its July 9, 2009, regulation to correct the date by which producers must register their farm with FDA, reflect a change in the address and telephone number for requesting copies of Form No. 3733, and reflect a change in the address to which producers must send their CD–ROM. DATES: Submit electronic or written comments on the SECG at any time. ADDRESSES: Submit electronic comments on the SECG to https:// www.regulations.gov. Submit written comments on the SECG to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the SECG to the Division of Plant and Dairy Food Safety/ Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS– 315), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax your request to 301– 436–1070. Send two self-addressed adhesive labels to assist that office in processing your request. See the E:\FR\FM\13APN1.SGM 13APN1

Agencies

[Federal Register Volume 75, Number 70 (Tuesday, April 13, 2010)]
[Notices]
[Page 18849]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8311]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Food and Drug Administration/National Heart Lung and Blood 
Institute/National Science Foundation Workshop on Computer Methods for 
Cardiovascular Devices: The Integration of Nonclinical and Clinical 
Models; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``FDA/NHLBI/NSF Workshop on Computer Methods for 
Cardiovascular Devices: The Integration of Nonclinical and Clinical 
Models.'' The workshop will include a smaller, optional session 
entitled ``Microstructure Modeling Session.'' FDA is cosponsoring the 
workshop with the National Heart Lung and Blood Institute of the 
National Institutes of Health and the National Science Foundation. The 
purpose of the workshop is to facilitate discussion between FDA and 
other interested parties on the use of computational modeling in the 
design, development, and evaluation of cardiovascular medical devices.
    Dates and Times: The optional session will be held on June 9, 2010, 
from 1 p.m. to 5:30 p.m. and the public workshop will be held on June 
10 and 11, 2010, from 8 a.m. to 5 p.m.
    Location: The public workshop and optional session 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, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1110, Silver Spring, MD 20993, 301-796-6309, 
donna.lochner@fda.hhs.gov.
    Registration: To register for the public workshop and optional 
session, please visit the following Web site: https://scpd.stanford.edu/publicViewHome.do?method=load. There is a registration fee to attend 
the public workshop to cover the expenses and attendees must register 
in advance. The fee for the meeting is $350. Students will be offered a 
discounted fee of $175. The exhibitors' fee is $600 and includes 
registration of one person. Fees will be waived for invited speakers 
and the organizing committee. The registration process will be handled 
by the Stanford Center for Professional Development. Although the 
facility is spacious, registration will be on a first-come, first-
served basis.
    If you need special accommodations because of a disability, please 
contact Donna R. Lochner at least 7 days before the public workshop.

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

    The purpose of the public workshop is to facilitate discussion 
between 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, 
with our overall theme being the integration of computer and 
nonclinical models. Topics include, but are not limited to the 
following:
     Multiscale, multiphysics, and multiphase modeling;
     Modeling of cardiovascular diseases and therapies;
     Patient-specific modeling, including virtual surgical 
planning and predictive biomedicine;
     Open source projects, including public policy initiatives, 
database development and data presentation, and standards and 
protocols; and
     Regulatory issues with implementation of computer 
modeling.

III. Where Can I Find Out More About This Public Workshop?

    Background information on the public workshop, registration 
information, the agenda, information about lodging, and other relevant 
information will be posted, as it becomes available, on the Internet at 
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm

    Dated: April 7, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-8311 Filed 4-12-10; 8:45 am]
BILLING CODE 4160-01-S
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