National Institute of Neurological Disorders and Stroke; Notice of Meeting, 49688 [E8-19442]

Download as PDF 49688 Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices jlentini on PROD1PC65 with NOTICES pending foreign counterparts [HHS Ref. No. E–099–1996/0]; 4. U.S. Patent No. 6,001,349 issued December 14, 1999 as well as issued and pending foreign counterparts [HHS Ref. No E–200–1990/3–US–01]; 5. U.S. Patent No.6,165,460 issued December 26, 2000; as well as issued and pending foreign counterparts [HHS Ref. No E–200–1990/4–US–01]; 6. U.S. Patent No. 7,118,738 issued October 10, 2006 as well as issued and pending foreign counterparts [HHS Ref. No E–154–1998/0–US–07]; 7. PCT Application No. PCT/US97/ 12203 filed July 15, 1997 [HHS Ref. No E–259–1994/3–PCT–02]; 8. U.S. Patent Application Nos. 10/ 197,127. and 08/686,280 filed July 17, 2002 and July 25, 1996 [HHS Ref. No E– 259–1994/3–US–08 and /4–US–01]; 9. U.S. Patent No. 6,946,133 issued September 20, 2005 as well as issued and pending foreign counterparts [HHS Ref. No E–062–1996/0–US–01]; 10. U.S. Patent Application No. 11/ 606,929 filed December 1, 2006 [E–062– 1996/0–US–11]; 11. U.S. Patent Nos. 6,893,869, 6,548,068 and 6,045,802 issued May 17, 2005, April 15, 2003 and April 4, 2000 respectively, as well as issued and pending foreign counterparts [HHS Ref. Nos. E–260–1994/1–US–03, US–02, US– 01]; and 12. U.S. Patent. Application No. 11/ 090,686 filed March 8, 2005 [HHS Ref. No E–260–1994/1–US–04]. Cooperative Research and Development Agreement (CRADA) Opportunities A CRADA partner for the further codevelopment of this technology is currently being sought by the Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI. The CRADA partner will (a) generate and characterize recombinant poxviruses expressing specific tumor-associated antigens, cytokines, and/or T-cell costimulatory factors, (b) analyze the recombinant poxviruses containing these genes with respect to appropriate expression of the encoded gene product(s), (c) supply adequate amounts of recombinant virus stocks for preclinical testing, (d) manufacture and test selected recombinant viruses for use in human clinical trials (with the exception of trials for prostatic diseases and melanoma), (e) submit Drug Master Files detailing the development, manufacture, and testing of live recombinant vaccines to support the NCI-sponsored IND and/or companysponsored IND, (f) supply adequate amounts of clinical grade recombinant poxvirus vaccines for clinical trials conducted at the NCI Center for Cancer VerDate Aug<31>2005 17:12 Aug 21, 2008 Jkt 214001 Research (CCR), and (g) provide adequate amounts of vaccines for extramural clinical trials, if agreed upon by the parties, and conduct clinical trials under company-sponsored or NCIsponsored INDs. NCI will (a) provide genes of tumor-associated antigens, cytokines and other immunostimulatory molecules for incorporation into poxvirus vectors, (b) evaluate recombinant vectors in preclinical models alone and in combination therapies, and (c) conduct clinical trials (with the exception of trials for prostatic diseases and melanoma) of recombinant vaccines alone and in combination therapies. Dated: August 14, 2008 Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8–19462 Filed 8–21–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Neurological Disorders and Stroke Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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: National Advisory Neurological Disorders and Stroke Council; Clinical Trials Subcommittee. Date: September 18, 2008. Closed: 8 a.m. to 9 a.m. Agenda: To review and evaluate grant applications and/or proposals. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Place: National Institutes of Health, Building 31, 31 Center Drive, C Wing, Conference Room 10, Bethesda, MD 20892. Open: 9 a.m. to 10 a.m. Agenda: To discuss clinical trials policy. Place: National Institutes of Health, Building 31, 31 Center Drive, C Wing, Conference Room 10, Bethesda, MD 20892. Contact Person: Deborah G Hirtz, MD, Acting Director, Clinical Trials Cluster, National Institute of Neurological, Disorders and Stroke, National Institute of Health, 6001 Executive Blvd., Suite 2212, Bethesda, MD 20892, (301) 496–5821, hirtz@ninds.nih.gov. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: www.ninds.nih.gov, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to NeurologicalDisorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: August 15, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–19442 Filed 8–21–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Meetings Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of meetings of the National Advisory Neurological Disorders and Stroke Council. The meetings will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Advisory Neurological Disorders and Stroke Council, Training, Career Development, and Special Programs Subcommittees. Date: September 17, 2008. Time: 8 p.m. to 10 p.m. E:\FR\FM\22AUN1.SGM 22AUN1

Agencies

[Federal Register Volume 73, Number 164 (Friday, August 22, 2008)]
[Notices]
[Page 49688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke; Notice 
of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of 
the National Advisory Neurological Disorders and Stroke Council.
    The meeting will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the 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: National Advisory Neurological Disorders and 
Stroke Council; Clinical Trials Subcommittee.
    Date: September 18, 2008.
    Closed: 8 a.m. to 9 a.m.
    Agenda: To review and evaluate grant applications and/or 
proposals.
    Place: National Institutes of Health, Building 31, 31 Center 
Drive, C Wing, Conference Room 10, Bethesda, MD 20892.
    Open: 9 a.m. to 10 a.m.
    Agenda: To discuss clinical trials policy.
    Place: National Institutes of Health, Building 31, 31 Center 
Drive, C Wing, Conference Room 10, Bethesda, MD 20892.
    Contact Person: Deborah G Hirtz, MD, Acting Director, Clinical 
Trials Cluster, National Institute of Neurological, Disorders and 
Stroke, National Institute of Health, 6001 Executive Blvd., Suite 
2212, Bethesda, MD 20892, (301) 496-5821, hirtz@ninds.nih.gov.
    In the interest of security, NIH has instituted stringent 
procedures for entrance onto the NIH campus. All visitor vehicles, 
including taxicabs, hotel, and airport shuttles will be inspected 
before being allowed on campus. Visitors will be asked to show one 
form of identification (for example, a government-issued photo ID, 
driver's license, or passport) and to state the purpose of their 
visit.
    Information is also available on the Institute's/Center's home 
page: www.ninds.nih.gov, where an agenda and any additional 
information for the meeting will be posted when available.

(Catalogue of Federal Domestic Assistance Program Nos. 93.853, 
Clinical Research Related to NeurologicalDisorders; 93.854, 
Biological Basis Research in the Neurosciences, National Institutes 
of Health, HHS)

    Dated: August 15, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
 [FR Doc. E8-19442 Filed 8-21-08; 8:45 am]
BILLING CODE 4140-01-P