Center for Scientific Review; Notice of Closed Meeting, 16272-16273 [2013-05849]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES 16272 Federal Register / Vol. 78, No. 50 / Thursday, March 14, 2013 / Notices announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss the efficacy and safety of new drug application (NDA) 22219, AVEED (testosterone undecanoate) intramuscular injection, submitted by Endo Pharmaceutical Solutions, Inc., for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil embolism in the lungs and potential anaphylactic reactions. In addition to AVEED, other approved testosterone injectable products will be referenced, especially in regard to oil embolism and potential anaphylactic reactions reported for those products. 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 http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting 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 4, 2013. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making 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 March 27, 2013. 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 VerDate Mar<15>2010 16:51 Mar 13, 2013 Jkt 229001 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 March 28, 2013. 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 Kalyani Bhatt 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: http://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: March 8, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–05861 Filed 3–13–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Cancer Institute; Notice of Closed Meetings 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/or contract proposals 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 or the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, NCI Provocative Questions. Frm 00030 Fmt 4703 Sfmt 4703 Dated: March 8, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–05847 Filed 3–13–13; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health PO 00000 Date: March 28, 2013. Time: 7:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Peter J. Wirth, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8131, Bethesda, MD 20892–8328 301–496–7565 pw2q@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel, Nanotechnology RNA Therapeutics. Date: April 18–19, 2013. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Thomas M. Vollberg, Ph.D., Scientific Review Officer, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 7142, Bethesda, MD 20892, 301–594–9582, vollbert@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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. The meeting 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. E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 78, No. 50 / Thursday, March 14, 2013 / Notices Name of Committee: Center for Scientific Review Special Emphasis Panel; Neurological disorders. Date: March 22, 2013. Time: 1:00 p.m. to 3:00 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: Samuel C. Edwards, Ph.D., IRG CHIEF, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435–1246, edwardss@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. (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, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: March 8, 2013. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd., Room 8061, Bethesda, MD 20892–8329, 301– 496–7174, venerk@mail.nih.gov. This notice is being published less than 15 days prior to the meeting date due to scheduling conflicts. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: March 8, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–05845 Filed 3–13–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2013–05849 Filed 3–13–13; 8:45 am] BILLING CODE 4140–01–P National Institute on Aging; Notice of Closed Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. The meeting 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. National Institutes of Health National Cancer Institute; Notice of Closed Meeting tkelley on DSK3SPTVN1PROD 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 meeting. The meeting 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel, Identification, Referral, and Follow-up of Patients who have HTLV. Date: March 20, 2013. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6116 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Kirt Vener, Ph.D., Branch Chief, Special Review and Logistics Branch, VerDate Mar<15>2010 16:51 Mar 13, 2013 Jkt 229001 Name of Committee: National Institute on Aging Special Emphasis Panel. Date: April 1, 2013. Time: 12:00 p.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, National Institutes of Health, Gateway Building, 7201 Wisconsin Avenue, Suite 2C– 212, Bethesda, MD 20814, (Telephone conference call). Contact Person: Ramesh Vemuri, Ph.D., Scientific Review Branch, National Institute on Aging, National Institutes of Health, Gateway Building, 7201 Wisconsin Avenue, Suite 2C–212, Bethesda, MD 20892, 301– 402–7700 rv23r@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 16273 Dated: March 8, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–05842 Filed 3–13–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, March 28, 2013, 8:00 a.m. to March 28, 2013, 5:00 p.m., National Institutes of Health, 6116 Executive Boulevard, Room 507, Rockville, MD, 20852 which was published in the Federal Register on March 04, 2013, 78FR14099. This notice is being amended to change the start time from 8:00 a.m. to 1:00 p.m. on March 28, 2013. The meeting is closed to the public. Dated: March 8, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–05846 Filed 3–13–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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. The meeting 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: Center for Scientific Review Special Emphasis Panel Member Conflict: Cardiovascular Clinical and Translational Studies Date: April 4, 2013. Time: 1:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 78, Number 50 (Thursday, March 14, 2013)]
[Notices]
[Pages 16272-16273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; 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.
    The meeting 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.


[[Page 16273]]


    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Neurological disorders.
    Date: March 22, 2013.
    Time: 1:00 p.m. to 3:00 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: Samuel C. Edwards, Ph.D., IRG CHIEF, Center for 
Scientific Review, National Institutes of Health, 6701 Rockledge 
Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-1246, 
edwardss@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.

(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, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: March 8, 2013.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-05849 Filed 3-13-13; 8:45 am]
BILLING CODE 4140-01-P