The General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 1396-1397 [2010-174]

Download as PDF srobinson on DSKHWCL6B1PROD with NOTICES 1396 Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Notices Name of Committee: Cardiovascular and Renal Drugs 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 March 1, 2010, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, Maryland Ballroom, 8727 Colesville Road, Silver Spring, MD. The hotel telephone number is 301–589– 5200. Contact Person: Elaine Ferguson, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827– 7001, FAX: 301–827–6776, e-mail: elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512533. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On March 1, 2010, the committee will discuss biologics license application (BLA) 125288, for belatacept injectable, by Bristol Myers Squibb, to be used in patients with kidney transplants to prevent rejection of the transplanted kidney. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. 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 on or before February 12, 2010. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make VerDate Nov<24>2008 16:06 Jan 08, 2010 Jkt 220001 formal oral presentations should notify the contact person 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 on or before February 4, 2010. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 5, 2010. 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 Elaine Ferguson at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 5, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–173 Filed 1–8–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] The General Hospital and Personal Use 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 (FDA). The meeting will be open to the public. Name of Committee: General Hospital and Personal Use 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 March 5, 2010, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons C, D and E, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Tracy Phillips, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512520. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On March 5, 2010, the committee will discuss and make recommendations regarding clinical risks and benefits of post-market actions in response to insulin pump failures. Insulin pumps are intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. 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 on or before February 22, 2010. Oral presentations from the public will be scheduled immediately following E:\FR\FM\11JAN1.SGM 11JAN1 Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Notices lunch. Those desiring to make formal oral presentations should notify the contact person 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 on or before February 11, 2010. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 12, 2010. 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 at 301–796–5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dates and Times: February 10, 2010, 8:30 a.m. to 5 p.m., February 11, 2010, 8:30 a.m. to 5 p.m. Place: Red Lion Hotel on Fifth Avenue, 1415 Fifth Avenue, Seattle, Washington 98101, Telephone: 206–971–8000, Fax: 206– 971–8100. Status: The meeting will be open to the public. Purpose: The purpose of the meeting is to discuss services and issues related to the health of migrant and seasonal farmworkers and their families and to formulate recommendations for the Secretary of Health and Human Services. Agenda: The agenda includes an overview of the Council’s general business activities. The Council will also hear presentations from experts on farmworker issues, including the status of farmworker health at the local and national levels. In addition, the Council will be holding a public hearing at which migrant farmworkers, community leaders, and providers will have the opportunity to testify before the Council regarding matters that affect the health of migrant farmworkers. The hearing is scheduled for Thursday, February 11 from 9 a.m. to 12 p.m., at the Red Lion Hotel on Fifth Avenue. The Council meeting is being held in conjunction with the Western Migrant Stream Forum sponsored by the Northwest Regional Primary Care Association, which is being held in Seattle, Washington, February 12–14, 2010. Agenda items are subject to change as priorities indicate. For Further Information Contact: Gladys Cate, Office of Minority and Special Populations, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, Maryland 20857; telephone (301) 594–0367. Dated: January 5, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. BILLING CODE 4165–15–P Dated: January 5, 2010. Sahira Rafiullah, Deputy Director, Division of Policy Review and Coordination. [FR Doc. 2010–274 Filed 1–8–10; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2010–174 Filed 1–8–10; 8:45 am] National Institutes of Health BILLING CODE 4160–01–S Center for Scientific Review; Notice of Closed Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES srobinson on DSKHWCL6B1PROD with NOTICES Health Resources and Services Administration National Advisory Council on Migrant Health; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on Migrant Health. VerDate Nov<24>2008 16:06 Jan 08, 2010 Jkt 220001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 1397 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Molecular Neuropharmacology and Signaling Study Section. Date: February 4–5, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Monaco, 700 F Street, NW.,Washington, DC 20001. Contact Person: Deborah L. Lewis, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4183, MSC 7850, Bethesda, MD 20892, 301–408– 9129, lewisdeb@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Population Sciences and Epidemiology. Date: February 10, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Fungai Chanetsa, MPH, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3135, MSC 7770, Bethesda, MD 20892, 301–408– 9436, fungai.chanetsa@nih.hhs.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Muscle Physiology and Diseases. Date: February 10, 2010. Time: 11 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Yi-Hsin Liu, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301–451– 1327, liuyh@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR09–224: System Dynamics Methodologies. Date: February 10, 2010. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Delia Olufokunbi Sam, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 20892, 301–435– 0695, olufokunbisamd@csr.nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Medical Imaging Study Section. E:\FR\FM\11JAN1.SGM 11JAN1

Agencies

[Federal Register Volume 75, Number 6 (Monday, January 11, 2010)]
[Notices]
[Pages 1396-1397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-174]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


The General Hospital and Personal Use 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: General Hospital and Personal Use 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 March 5, 2010, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons C, D and 
E, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Tracy Phillips, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 3014512520. 
Please call the Information Line for up-to-date information on this 
meeting. A notice in the Federal Register about last minute 
modifications that impact a previously announced advisory committee 
meeting cannot always be published quickly enough to provide timely 
notice. Therefore, you should always check the agency's Web site and 
call the appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: On March 5, 2010, the committee will discuss and make 
recommendations regarding clinical risks and benefits of post-market 
actions in response to insulin pump failures. Insulin pumps are 
intended for continuous delivery of insulin at set and variable rates 
and as an aid in the management of diabetes mellitus in persons 
requiring insulin.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    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 on or before 
February 22, 2010. Oral presentations from the public will be scheduled 
immediately following

[[Page 1397]]

lunch. Those desiring to make formal oral presentations should notify 
the contact person 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 on or before 
February 11, 2010. Time allotted for each presentation may be limited. 
If the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by February 12, 
2010.
    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 at 
301-796-5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 5, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-174 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S

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