Science Advisory Board to the National Center for Toxicological Research Notice of Meeting, 57967-57968 [2010-23843]

Download as PDF Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: September 16, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. Dated: September 16, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–23846 Filed 9–22–10; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2010–23844 Filed 9–22–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Center for Scientific Review; Notice of Closed Meetings Food and Drug Administration srobinson on DSKHWCL6B1PROD with NOTICES 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 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Biology of Development and Aging Integrated Review Group; Aging Systems and Geriatrics Study Section. Date: October 4, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard by Marriot, 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Contact Person: James P Harwood, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5168, MSC 7840, Bethesda, MD 20892, 301–435– 1256, harwoodj@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA Panel: Scientific Models to Improve Health. Date: October 20, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Washington Marriott Wardman Park Hotel, 2660 Woodley Road, NW., Washington, DC 20008. Contact Person: Hilary D Sigmon, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, (301) 594– 6377, sigmonh@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, VerDate Mar<15>2010 16:52 Sep 22, 2010 Jkt 220001 [Docket No. FDA–2010–N–0001] Science Advisory Board to the National Center for Toxicological Research 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). At least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). 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 October 19, 2010, from 8:15 a.m. to 5:30 p.m. and on October 20, 2010, from 8:30 a.m. to 1 p.m. Location: National Center for Toxicological Research, 3900 NCTR Dr., Jefferson, AR 72079, Conference Room B–12. Contact Person: Margaret Miller, NCTR, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 2208, Silver Spring, MD, 20993– 0002, 301–796–8890, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 301–451– 2559. 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 October 19, 2010, NCTR Director will provide a Center-wide update on scientific endeavors and PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 57967 discuss prioritization, alignment, and the strategic focus of NCTR. The SAB will be presented with updates from each of the NCTR divisions on their individual accomplishments and future research plans based on the major items identified in the last subcommittee review. The report of the subcommittee review of the Division of Neurotoxicology will be presented for discussion and adoption by the full Board. On October 20, 2010, the SAB will be presented with and discuss the NCTR Strategic Focus and future direction, and the need for research and potential collaborations. A discussion will be conducted on the organization of the SAB, site visits and SAB assignments. 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: On October 19, 2010, from 8:15 a.m. to 5:30 p.m., the meeting is open to the public. 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 October 18, 2010. Oral presentations from the public will be scheduled between approximately 12 p.m. to 1 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 October 8, 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 October 11, 2010. Closed Committee Deliberations: On October 20, 2010, from 12 p.m. to 1 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted E:\FR\FM\23SEN1.SGM 23SEN1 57968 Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be closed to permit discussion of information concerning individuals associated with the research programs at NCTR. 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 Margaret Miller 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: September 17, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–23843 Filed 9–22–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. srobinson on DSKHWCL6B1PROD with NOTICES 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: Gastroenterology and Urology 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 December 2 and 3, 2010, from 8 a.m. to 6 p.m. VerDate Mar<15>2010 16:52 Sep 22, 2010 Jkt 220001 Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Margaret McCabeJanicki, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993–0002, 301–796–7029, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512523. 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 December 2, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal incontinence in patients who have failed conservative therapy. On December 3, 2010, the committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND Adjustable Gastric Banding System, sponsored by Allergan. The sponsor is requesting an expanded Indication for Use for their LAP-BAND Adjustable Gastric Banding System to include weight reduction in patients with a Body Mass Index (BMI) of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more comorbid conditions. 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 November 18, 2010. Oral presentations from the public will PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 be scheduled between approximately 1 p.m. and 2 p.m. on December 2 and 3, 2010. 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 November 10, 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 November 11, 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, Conference Management Staff, 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/AboutAdvisory Committees/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: September 17, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–23842 Filed 9–22–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting 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 meeting. E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 75, Number 184 (Thursday, September 23, 2010)]
[Notices]
[Pages 57967-57968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23843]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Science Advisory Board to the National Center for Toxicological 
Research 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Science Advisory Board (SAB) to the National 
Center for Toxicological Research (NCTR).
    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 October 19, 2010, from 
8:15 a.m. to 5:30 p.m. and on October 20, 2010, from 8:30 a.m. to 1 
p.m.
    Location: National Center for Toxicological Research, 3900 NCTR 
Dr., Jefferson, AR 72079, Conference Room B-12.
    Contact Person: Margaret Miller, NCTR, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 2208, Silver 
Spring, MD, 20993-0002, 301-796-8890, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 301-451-2559. 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 October 19, 2010, NCTR Director will provide a Center-
wide update on scientific endeavors and discuss prioritization, 
alignment, and the strategic focus of NCTR. The SAB will be presented 
with updates from each of the NCTR divisions on their individual 
accomplishments and future research plans based on the major items 
identified in the last subcommittee review. The report of the 
subcommittee review of the Division of Neurotoxicology will be 
presented for discussion and adoption by the full Board. On October 20, 
2010, the SAB will be presented with and discuss the NCTR Strategic 
Focus and future direction, and the need for research and potential 
collaborations. A discussion will be conducted on the organization of 
the SAB, site visits and SAB assignments.
    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: On October 19, 2010, from 8:15 a.m. to 5:30 p.m., the 
meeting is open to the public. 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 October 18, 2010. Oral presentations from the public will be 
scheduled between approximately 12 p.m. to 1 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 October 8, 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 October 11, 2010.
    Closed Committee Deliberations: On October 20, 2010, from 12 p.m. 
to 1 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted

[[Page 57968]]

invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the 
meeting will be closed to permit discussion of information concerning 
individuals associated with the research programs at NCTR.
    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 Margaret Miller 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: September 17, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-23843 Filed 9-22-10; 8:45 am]
BILLING CODE 4160-01-S

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