Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 7696-7697 [E9-3488]

Download as PDF 7696 Federal Register / Vol. 74, No. 32 / Thursday, February 19, 2009 / Notices from 15% to 36% for females. Sexual violence against men, although less prevalent, is also a public health problem; approximately 1 in 6 women and 1 in 33 men have experienced an attempted or completed rape in their lifetime. Over 302,000 women and 92,000 men were raped in the past 12 months. Thirty percent of rape victims experience major depressions at some time in their lives; 33% of victimized women and 24.2% of victimized men are counseled by a health professional; 31% develop post traumatic stress disorder; 33% contemplate suicide; and 13% attempt suicide. Each year, approximately 1 million women and 371,000 men in the United States are stalked. There is a strong link between stalking and other forms of violence in intimate relationships; 81% of women who were stalked by a current or former intimate partner were also physically assaulted by that partner and 31% were sexually assaulted by that partner. Furthermore, 76% of female victims of intimate partner homicides were stalked by their partners before they were killed. Currently, the United States lacks a national data source that systematically and routinely collects valid and reliable information on the magnitude and trends in IPV, SV and stalking. Such a system is needed to (1) Help formulate public policies and prevention strategies related to IPV, SV and stalking; (2) guide and evaluate progress in reducing the huge health and social burden associated with IPV, SV and stalking; and (3) improve the effectiveness of federal agencies responding to IPV, SV and stalking. In order to address this important public health problem, CDC plans to develop a national surveillance system that will generate national and state level estimates of IPV, SV and stalking. A total of 20,948 eligible households will be screened; out of the households screened 10,948 are estimated to consent or agree to participate and 10,000 are estimated to complete the survey each year. The survey will be conducted among English and/or Spanish speaking male and female adults (18 years and older) living in the United States. In addition, special populations are also being targeted such as an oversample of American Indian/ Alaska Native populations, female active duty military service members (first year of data collection only), and female spouses of married male active duty military service members (first year of data collection only). Each year, NISVSS will provide precise and stable annual prevalence estimates for IPV, SV, and stalking victimization at the national level. As data collection continues in subsequent years, sample sizes will increase and stable state-level lifetime prevalence data will also be available for both women and men in all states. All information will be collected in a 20–25 minute anonymous interview conducted over the telephone, using computerassisted telephone interviewing (CATI) software. The use of CATI will reduce respondent burden, reduce coding errors, and increase efficiency and data quality. Questions will be asked about all forms of IPV victimization (including physical aggression, psychological aggression, and sexual violence); all forms of SV victimization by any perpetrator (including unwanted sexual situations, abusive sexual contact, and forced/nonconsensual sex [completed and attempted]); and stalking victimization by any perpetrator. NISVSS will gather information regarding experiences that occurred across the lifespan and within the 12 and 36 months preceding the survey. Such data will help inform public policies and prevention strategies at both the national and state levels and will help guide and evaluate progress toward reducing the substantial health and social burden associated with IPV, SV, and stalking. There are no costs to respondents other than their time. TOTAL ESTIMATED ANNUALIZED BURDEN TABLE Number of responses Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondent Form name Households ....................................... Screened .......................................... Surveyed .......................................... 20,948 10,000 1 1 3/60 25/60 1,047 4,167 Total ........................................... ........................................................... ........................ ........................ ........................ 5,214 Dated: February 6, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–3495 Filed 2–18–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sroberts on PROD1PC70 with NOTICES [Docket No. FDA–2009–N–0664] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. VerDate Nov<24>2008 17:38 Feb 18, 2009 Jkt 217001 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: Circulatory System 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 18, 2009, from 8 a.m. to 5:30 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Contact Person: James Swink, Center for Devices and Radiological Health (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4050, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512625. 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 E:\FR\FM\19FEN1.SGM 19FEN1 sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 74, No. 32 / Thursday, February 19, 2009 / Notices about possible modifications before coming to the meeting. Agenda: The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by TherOx, Inc., for the TherOx Aqueous Oxygen System (AO System). The system is intended for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization less than or equal to 6 hours from symptom onset. These patients were randomized to AO Therapy or not. The endpoint is reduction in the final size of the infarct. The system draws blood from the patient, hyperoxygenates it with the AO cartridge component of the system, and reinfuses the blood via the infusion catheter directly to the infarction site of the heart. This therapy is intended to be performed for 90 minutes post percutaneous coronary intervention/ stenting. 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/ohrms/ dockets/ac/acmenu.htm, click on the year 2009 and 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 March 4, 2009. Oral presentations from the public will be scheduled approximately 30 minutes at the beginning of committee deliberations and approximately 30 minutes near the end of the deliberations. 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 25, 2009. 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 VerDate Nov<24>2008 17:38 Feb 18, 2009 Jkt 217001 regarding their request to speak by February 26, 2009. 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 240–276–8932, 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/oc/advisory/ default.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: February 10, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–3488 Filed 2–18–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Sexually Transmitted Infections Cooperative Research Centers. Date: March 3–5, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: The Crowne Plaza Hotel, 8777 Georgia Avenue, Silver Spring, MD 20910. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 7697 Contact Person: Michelle M. Timmerman, PhD, Scientific Review Officer, Scientific Review Program, NIH/NIAID/DHHS, Room 3147, 6700B Rockledge Drive, MSC–7616, Bethesda, MD 20892–7616, 301–451–4573, timmermanm@niaid.nih.gov. NAME OF COMMITTEE: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Review of Unsolicited P01 Application. Date: March 10, 2009. Time: 11 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Eleazar Cohen, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, Room 3129, 6700B Rockledge Drive, Bethesda, MD 20892, (301) 435–3564, ec17w@nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Review of Unsolicited P01 Application. Date: March 12, 2009. Time: 11 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Eleazar Cohen, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, Room 3129, 6700B Rockledge Drive, Bethesda, MD 20892, (301) 435–3564, ec17w@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: February 11, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–3437 Filed 2–18–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment; Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given of the meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council on March 19, 2009. The meeting is open to the public and will include discussion of the Center’s policy issues, and current administrative, legislative, and program developments. E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[Federal Register Volume 74, Number 32 (Thursday, February 19, 2009)]
[Notices]
[Pages 7696-7697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3488]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Circulatory System 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: Circulatory System 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 18, 2009, from 8 
a.m. to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: James Swink, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-4050, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512625. 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

[[Page 7697]]

about possible modifications before coming to the meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application, sponsored by TherOx, Inc., for the 
TherOx Aqueous Oxygen System (AO System). The system is intended for 
use in acute myocardial infarction (AMI) patients, who have undergone 
successful revascularization less than or equal to 6 hours from symptom 
onset. These patients were randomized to AO Therapy or not. The 
endpoint is reduction in the final size of the infarct. The system 
draws blood from the patient, hyperoxygenates it with the AO cartridge 
component of the system, and reinfuses the blood via the infusion 
catheter directly to the infarction site of the heart. This therapy is 
intended to be performed for 90 minutes post percutaneous coronary 
intervention/stenting.
    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/ohrms/dockets/ac/acmenu.htm, click on 
the year 2009 and 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 
March 4, 2009. Oral presentations from the public will be scheduled 
approximately 30 minutes at the beginning of committee deliberations 
and approximately 30 minutes near the end of the deliberations. 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 25, 2009. 
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 26, 2009.
    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 240-276-8932, 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/oc/advisory/
default.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: February 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-3488 Filed 2-18-09; 8:45 am]
BILLING CODE 4160-01-S

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