Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 19231-19232 [E9-9641]

Download as PDF Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices 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 May 6, 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 May 7, 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: April 22, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–9642 Filed 4–27–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. erowe on PROD1PC64 with NOTICES 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: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and technical issues, as well as emerging issues within the scientific community in industry and academia. Additionally, the Science Board provides VerDate Nov<24>2008 15:33 Apr 27, 2009 Jkt 217001 advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, on formulating an appropriate research agenda, and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs. Date and Time: The meeting will be held on Monday, May 18, 2009, from 9 a.m. to 3 p.m. Addresses: Hilton Washington DC/ Rockville Hilton, 1750 Rockville Pike, Rockville, MD 20852. ˜ Contact Person: Carlos Pena, Office of the Commissioner, Food and Drug Administration (HF–33), 5600 Fishers Lane, Rockville, MD 20857, 301–827–6687, or FDA Advisory Committee Information Line, 1– 800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512603. Please call the Information Line for up-todate 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: The Science Board will hear about and discuss updates from the following subcommittees: (1) The review of each Center’s projects within scientific priority areas, (2) the review of research at the Center for Veterinary Medicine, and (3) the review of FDA’s scientific information technology infrastructure modernization initiatives. The Science Board will also hear updates on rapid detection of Salmonella in foods and the handling of biospecimens used for genomic and proteomic analyses. 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 May 11, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 May 7, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 19231 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 May 8, 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 Dr. Carlos ˜ Pena 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: April 22, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–9643 Filed 4–27–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Neurological 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: Neurological 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 May 14, 2009, from 8 a.m. to 5 p.m. Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: Peter L. Hudson, Center for Devices and Radiological Health, (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240– 276–3737, or FDA Advisory Committee Information Line, 1–800–741–8138 (301– 443–0572 in the Washington, DC area), code 3014512513. Please call the Information Line for up-to-date information on this meeting. A E:\FR\FM\28APN1.SGM 28APN1 erowe on PROD1PC64 with NOTICES 19232 Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices 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: The committee will discuss, make recommendations and vote on a premarket approval application for the DuraSeal XactTM Sealant System, sponsored by Confluent Surgical Inc. This device is indicated for use as an adjunct to sutured dural repair to obtain watertight closure during spinal surgery. 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 April 30, 2009. Oral presentations from the public will be scheduled for 30 minutes at the beginning of the committee deliberations and for 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 April 28, 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 April 29, 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 Ms. 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. VerDate Nov<24>2008 15:33 Apr 27, 2009 Jkt 217001 Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 22, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–9641 Filed 4–27–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I delegate to the Director of the Office of Refugee Resettlement the following authority delegated to the Assistant Secretary for Children and Families by the Secretary of the Department of Health and Human Services (HHS) under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008, Public Law 110–457, section 235. (a) Authority Delegated 1. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(a)(1) to work in conjunction with the Secretary of Homeland Security, the Secretary of State, and the Attorney General, to develop policies and procedures to ensure that unaccompanied alien children (UAC) are safely repatriated to their country of nationality or of last habitual residence. 2. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(a)(5)(A) to work in conjunction with the Secretary of State and the Secretary of Homeland Security, nongovernmental organizations, and other national and international agencies and experts, to create a pilot program to develop and implement best practices for the repatriation and reintegration of UAC. 3. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(b)(1) to provide care and custody of all UAC, except as otherwise provided under section 235(a), including responsibility for their detention, where appropriate. 4. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(b)(4) to develop age determination procedures in consultation with the Secretary of Homeland Security. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 5. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(c)(1) to establish policies and programs to ensure that UAC are protected from traffickers and other persons seeking to victimize or otherwise engage such children in criminal, harmful or exploitative activity. 6. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(c)(2) to place an unaccompanied alien child in the least restrictive setting that is in the best interest of the child. In making such placements, personnel in the Administration for Children and Families may consider danger to self, danger to the community, and risk of flight. Concerning placements in a secure facility, the personnel in the Administration for Children and Families shall review the placements, at a minimum, on a monthly basis to determine if such placements remain warranted. Placement of child trafficking victims may include placement in an Unaccompanied Refugee Minor (URM) program, pursuant to section 412(d) of the Immigration and Nationality Act (8 U.S.C. 1522(d)). 7. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(c)(3)(A) to place an unaccompanied alien child with a custodian upon determining that the proposed custodian is capable of providing for the child’s physical and mental well-being. Such determination shall, at a minimum, include verification of the custodian’s identity and relationship to the child and an independent finding that the custodian has not engaged in any activity that would pose a potential risk to the child. 8. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(c)(3)(B) to conduct a home study for a child who is a victim of a severe form of trafficking in persons, a special needs child with a disability, a child who has been a victim of physical or sexual abuse under circumstances that indicate that the child’s health or welfare has been significantly harmed or threatened, or a child whose proposed sponsor clearly presents a risk of abuse, maltreatment, exploitation, or trafficking to the child based on all available objective evidence. 9. Authority under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(c)(3)(B) to conduct follow- E:\FR\FM\28APN1.SGM 28APN1

Agencies

[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19231-19232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9641]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Neurological 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: Neurological 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 May 14, 2009, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Peter L. Hudson, Center for Devices and 
Radiological Health, (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3737, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512513. Please call the Information 
Line for up-to-date information on this meeting. A

[[Page 19232]]

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: The committee will discuss, make recommendations and 
vote on a premarket approval application for the DuraSeal Xact\TM\ 
Sealant System, sponsored by Confluent Surgical Inc. This device is 
indicated for use as an adjunct to sutured dural repair to obtain 
watertight closure during spinal surgery.
    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 
April 30, 2009. Oral presentations from the public will be scheduled 
for 30 minutes at the beginning of the committee deliberations and 
for 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 April 28, 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 April 29, 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 Ms. 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: April 22, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-9641 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S

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