Computational Modeling for Cardiovascular Devices; Public Workshop, 19097-19098 [E9-9474]

Download as PDF 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] BILLING CODE 4160–01–S 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: BILLING CODE 4163–18–P 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 VerDate Nov<24>2008 15:55 Apr 24, 2009 Jkt 217001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 19097 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 19098 Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices • Regulatory issues with implementation of computer modeling. III. Is There a Fee and How Do I Register for the Public Workshop? There is a fee to attend the public workshop to defray the costs of meals provided and other expenses. The fee for the public workshop is $250. The registration process will be handled by BL Seamon. BL Seamon has extensive experience in planning, executing, and organizing educational meetings. Register online at https:// www.blseamon.com. Although the facility is spacious, registration will be on a first-come, first-served basis. If you need special accommodations due to a disability, please contact Donna R. Lochner at least 7 days before the public workshop. IV. 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/cdrh/ dsma/workshop.html. Dated: April 16, 2009. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E9–9474 Filed 4–27–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Part C Early Intervention Services Grant pwalker on PROD1PC71 with NOTICES AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of Noncompetitive Replacement Award to Joseph P. Addabbo Family Health Center. SUMMARY: The Health Resources and Services Administration (HRSA) will be transferring Ryan White HIV/AIDS Part C Early Intervention Services Grant funds (authorized by Title XXVI of the Public Health Service Act) originally awarded to Caritas Health Care, Inc., to the Joseph P. Addabbo Family Health Center in order to ensure continuity of critical HIV medical care and treatment services to clients in Jamaica/Southeast Queens, Borough of Queens, New York City, New York. SUPPLEMENTARY INFORMATION: VerDate Nov<24>2008 15:55 Apr 24, 2009 Jkt 217001 Former Grantee of Record: Caritas Health Care, Inc. Original Period of Grant Support: July 1, 2006, to June 30, 2011. Replacement Awardee: Joseph P. Addabbo Family Health Center. Amount of Replacement Award: $388,253. Period of Replacement Award: The period of support for the replacement award is March 1, 2009, to March 31, 2010. Authority: Section 2651 of the Public Health Service Act, 42 U.S.C. 300ff–51. CFDA Number: 93.918. Justification for the Exception to Competition: The former grantee, Caritas Health Care, Inc., notified HRSA that it would not continue providing services after February 28, 2009, as it is ceasing operations. It is critical that there be continuity in the medical care and treatment of approximately 430 lowincome patients with HIV/AIDS in the original service area, Jamaica/Southeast Queens, Borough of Queens, New York City, in New York. The Joseph P. Addabbo Family Health Center is located in the same geographical area previously served by Caritas Health Care, Inc., is a current Part C grantee with an established record of providing critical HIV/AIDS care and treatment, and has purchased the St. Dominic’s Family Health Center facility, one of the sites where the Ryan White services for Caritas Health Care, Inc., were provided. This temporary replacement award will ensure that there is no disruption of critical care and services to the service population while the service area is recompeted. This service area will be included in the upcoming competition for the Part C HIV Early Intervention Services competing application process for project periods starting April 1, 2010. FOR FURTHER INFORMATION CONTACT: Maria C. Rios, via e-mail mrios@hrsa.gov, or via telephone, 301– 443–0493. Dated: April 17, 2009. Mary K. Wakefield, Administrator. [FR Doc. E9–9516 Filed 4–24–09; 8:45 am] BILLING CODE 4165–15–P PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Agency Information Collection Activities: Application for Overflight Program/Advance Notice for Aircraft Landings AGENCY: U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-day notice and request for comments; extension of an existing collection of information: 1651–0087. SUMMARY: As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Application for Overflight Program/Advance Notice for Aircraft Landings. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before June 26, 2009, to be assured of consideration. ADDRESSES: Direct all written comments to the U.S. Customs and Border Protection, Attn.: Tracey Denning, Office of Regulations and Rulings, 799 9th Street, NW., 7th Floor, Washington, DC 20229–1177 FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to U.S. Customs and Border Protection, Attn.: Tracey Denning, Office of Regulations and Rulings, 799 9th Street, NW., 7th Floor, Washington, DC 20229–1177, Tel. (202) 325–0265. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13; 44 U.S.C. 3505(c)(2)). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual costs burden to respondents or record keepers from the collection of information (a total capital/startup costs E:\FR\FM\27APN1.SGM 27APN1

Agencies

[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Notices]
[Pages 19097-19098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9474]


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

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 co-sponsoring 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, e-mail: 
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.

[[Page 19098]]

     Regulatory issues with implementation of computer 
modeling.

III. Is There a Fee and How Do I Register for the Public Workshop?

    There is a fee to attend the public workshop to defray the costs of 
meals provided and other expenses. The fee for the public workshop is 
$250. The registration process will be handled by BL Seamon. BL Seamon 
has extensive experience in planning, executing, and organizing 
educational meetings. Register online at https://www.blseamon.com. 
Although the facility is spacious, registration will be on a first-
come, first-served basis.
    If you need special accommodations due to a disability, please 
contact Donna R. Lochner at least 7 days before the public workshop.

IV. 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/cdrh/dsma/workshop.html.

    Dated: April 16, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-9474 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.