National Eye Institute; Notice of Closed Meeting, 51628-51629 [06-7226]

Download as PDF 51628 Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Notices jlentini on PROD1PC65 with NOTICES Publication: T. M Sissung et al. Association of ABCB1 genotypes with paclitaxel-mediated neutropenia and peripheral neuropathy, To be submitted to Clinical Pharmacology and Therapy. Patent Status: U.S. Provisional Application No. 60/807,453 filed 14 Jul 2006 (HHS Reference No. E–237–2006/ 0–US–01). Licensing Status: Available for nonexclusive or exclusive licensing. Licensing Contact: David Lambertson, PhD; 301/435–4632; lambertsond@od.nih.gov. Collaborative Research Opportunity: The NCI Medical Oncology Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize ABCB1 genotyping to predict paclitaxel toxicity. Please contact Betty Tong, PhD at 301–496–0477, tongb@mail.nih.gov for more information. Use of Grape Skin Extracts as AntiCancer Agents Description of Technology: The invention describes anti-tumor effects of extracts from grape skins. Grape skin extract and derivatives may therefore be useful as preventive or therapeutic agents against tumor development. Literature indicates that grape and red wine consumption may be inversely associated with prostate cancer risk. Moreover, to date there are no known grape skin extract-associated toxicities described. The current invention discloses that grape skin extract, or purified fractions thereof, inhibited metastatic growth in human prostate transformed cell lines. Specifically, grape skin extract induced cellular apoptosis via inhibition of the phosphatidylinositol 3-kinase (PI3-K)/ Akt survival pathway. Historically, anti-tumor effects of grapes were mainly attributed to resveratrol, a phytoalexin present in grapes, nuts and wild berries. However, resveratrol’s mechanism of anti-tumor action is distinct from that of grape skin extract, in that it arrests cell cycle division without significant induction of apoptosis. The current invention also provides for methods of treating patients with prostate cancer or persons at risk for developing prostate cancer with compositions that include grape skin extract or active anti-tumor fractions thereof. Development Status: Pre-clinical stage. Inventors: Tamaro Hudson and Jeffrey E. Green (NCI). Patent Status: U.S. Provisional Application No. 60/789,181 filed 03 VerDate Aug<31>2005 16:39 Aug 29, 2006 Jkt 208001 April 2006 (HHS Reference No. E–179– 2006/0–US–01). Licensing Status: Available for nonexclusive or exclusive licensing. Licensing Contact: David A. Lambertson, PhD; 301–435–4632; lambertsond@od.nih.gov. Collaborative Research Opportunity: The NCI’s Laboratory of Cell Regulation and Carcinogenesis is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Patrick Twomey, PhD at 301– 496–0477 or twomeyp@mail.nih.gov for more information. Dated: August 23, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–14353 Filed 8–29–06; 8:45 am] September 13, 2006, 6 p.m., Doubletree Hotel, 8120 Wisconsin Ave., Bethesda, MD, 20814 which was published in the Federal Register on July 25, 2006. 71 FR 42098. The meeting notice is amended to reflect the change in hotel from the Doubletree Hotel, 8120 Wisconsin Ave., Bethesda, MD 20814 to the Clarion Hotel, 8400 Wisconsin Ave., Bethesda, MD 20814. The meeting is closed to the public. Dated: August 22, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–7229 Filed 8–29–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Center on Minority Health and Health Disparities; Amended Notice of Meeting National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meting of the National Cancer Institute Special Emphasis Panel, September 11, 2006, 5 p.m. to September 13, 2006, 5 p.m. Doubletree Hotel Bethesda, 8120 Wisconsin Ave., Bethesda, MD, 20814 which was published in the Federal Register on July 25, 2006, 71 FR 42099. The meeting notice is amended to reflect the change in hotel from the Doubletree Hotel, 8120 Wisconsin Ave., Bethesda, MD 20814 to the Clarion Hotel, 8400 Wisconsin Ave., Bethesda, MD 20814. The meeting is closed to the public. Dated: August 22, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–7228 Filed 8–29–06; 8:45 am] BILLING CODE 4140–01–M 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, September 11, 2006, 5 p.m. to PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Notice is hereby given of a change in the meeting of the National Advisory Council on Minority Health and Health Disparities, September 12, 2006, 8:30 a.m. to September 12, 2006, 5 p.m., National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD, 20892 which was published in the Federal Register on August 18, 2006, 71 FR 47817. The meeting location changed to the Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, Maryland 20814. The meeting is partially closed to the public. Dated: August 23, 2006. Anna Snouffer Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–7227 Filed 8–29–06; 8:45 am] BILLING CODE 4140–01–M 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. Appendix 2), notice is hereby given of the following meetings. 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 E:\FR\FM\30AUN1.SGM 30AUN1 Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Notices 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 Eye Institute, NEI Conference Application Review. Date: August 31, 2006. Time: 4:30 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892; (Telephone Conference Call). Contact Person: Houmam H. Araj, PhD, Scientific Review Administrator, Division of Extramural Research, National Eye Institute; 5635 Fishers Lane, Suite 1300, Bethesda, MD 20892; 301–451–2020; haraj@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the limitations imposed by the review and funding cycle. (Catalog of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: August 23, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–7226 Filed 8–29–06; 8:45 am] BILLING CODE 4141–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Information (RFI): Proposed Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) jlentini on PROD1PC65 with NOTICES ACTION: Notice. SUMMARY: The NIH is seeking comments regarding a proposed policy for NIH supported or conducted Genome-Wide Association Studies (GWAS). A genomewide association study is currently defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. The proposed policy addresses (1) data sharing procedures, (2) data access principles, (3) intellectual property and (4) issues regarding the protection of research participants through all phases of GWAS. Many of the principles contained in the policy reflect and extend existing NIH polices (e.g., the VerDate Aug<31>2005 16:39 Aug 29, 2006 Jkt 208001 2003 data sharing policy 1) and other recent NIH discussions.2 DATES: Reponses must be received by October 31, 2006 in order to ensure that the NIH will be able to consider the comments when developing new policies. FOR FURTHER INFORMATION CONTACT: Inquiries will be accepted at: https:// grants.nih.gov/grants/guide/rfi_files/ NOT–OD–06–094_rfi_add.htm or GWAS@nih.gov. Comments can be mailed to NIH GWAS RFI Comments, National Institutes of Health, Office of Extramural Research, 6705 Rockledge Drive, Room 350, Bethesda, MD 20892– 7963. SUPPLEMENTARY INFORMATION: Background The NIH is interested in advancing GWAS to identify common genetic factors that influence health and disease. Whole genome information, when combined with clinical and other phenotypic data, offers the potential for increased understanding of basic biological processes affecting human health, improvement in the prediction of disease and patient care, and ultimately the realization of the promise of personalized medicine. In addition, rapid advances in understanding the patterns of human genetic variation and maturing high-throughput, cost-effective methods for genotyping are providing powerful research tools for identifying genetic variants that contribute to health and disease. For these reasons, the NIH announced this spring that it has planned to: (1) Update the NIH data sharing policy for research applications involving GWAS data; (2) initiate a public consultation process to inform policy development activities; and (3) track GWAS applications and awards at a central level (see https://grants.nih.gov/ grants/guide/notice-files/NOT-OD–06– 071.html). This RFI serves as the first step in the public consultation process referenced in the May 15, 2006 Notice. Protecting Research Participants. The potential for public benefit to be achieved through sharing GWAS data is significant. However, genotypic and phenotypic information generated about individuals, such as data related to the presence or risk of developing particular diseases or conditions, and information regarding paternity or ancestry, may be 1 The 2003 NIH Data Sharing Policy applies to investigators seeking $500,000 or more in direct costs in any year (https://grants2.nih.gov/grants/ policy/data_sharing/data_sharing_guidance.htm). 2 Request for Information on Modifications to the NHLBI Policy for Distribution of Data from Clinical Trials and Epidemiology Studies (https:// www.nhlbi.nih.gov/funding/policies/rfigenome.htm), 2006. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 51629 sensitive and substantial. Therefore, it is critically important that the privacy and confidentiality of the participants be protected. Risks to individuals, groups, or communities should be carefully balanced with potential benefits of the knowledge to be gained through GWAS. The nature of GWAS information about participants and the broad data distribution goals of the NIH GWAS data repository highlight the importance of the informed consent process to this research. In order to protect research participants, the NIH will establish mechanisms to oversee the repository and monitor GWAS data use practices. The NIH recognizes that there are evolving scientific, ethical and societal issues relevant to this proposed policy and will revisit and revise the policy as appropriate. Proposed Policy for Genome-Wide Association Studies (GWAS) Principles Consistent with both the NIH mission to improve public health through research and its longstanding legislative mandate to make available to the public the results of the research activities that it supports and conducts, the NIH believes that the full value of GWAS to the public can be realized only if the genotype and phenotype datasets are made available as rapidly as possible to a wide range of scientific investigators. Rapid and broad data access is particularly important for GWAS because of the significant resources involved; the challenges of analyzing large datasets; and the extraordinary opportunities for making comparisons across multiple studies. Protection of research participants is a fundamental principle underlying biomedical research. The NIH is committed to responsible stewardship of data throughout the research process, which is essential to protecting the interests of study participants and to maintaining public trust in biomedical research. Applicability This draft policy is proposed to apply to active research applications identified by applicants or NIH staff as GWAS per NOT–OD–06–071. Data Management Data Repository. To facilitate broad and consistent access to NIH-supported GWAS datasets, the NIH proposes the development of a central GWAS data repository, at the NIH (National Center for Biotechnology Information [NCBI], National Library of Medicine). The repository will provide a single point of E:\FR\FM\30AUN1.SGM 30AUN1

Agencies

[Federal Register Volume 71, Number 168 (Wednesday, August 30, 2006)]
[Notices]
[Pages 51628-51629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7226]


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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. Appendix 2), notice is hereby given of the following 
meetings.
    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

[[Page 51629]]

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 Eye Institute, NEI Conference 
Application Review.
    Date: August 31, 2006.
    Time: 4:30 p.m. to 6 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 5635 Fishers Lane, 
Bethesda, MD 20892; (Telephone Conference Call).
    Contact Person: Houmam H. Araj, PhD, Scientific Review 
Administrator, Division of Extramural Research, National Eye 
Institute; 5635 Fishers Lane, Suite 1300, Bethesda, MD 20892; 301-
451-2020; haraj@mail.nih.gov.

    This notice is being published less than 15 days prior to the 
meeting due to the limitations imposed by the review and funding 
cycle.

(Catalog of Federal Domestic Assistance Program Nos. 93.867, Vision 
Research, National Institutes of Health, HHS)

    Dated: August 23, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 06-7226 Filed 8-29-06; 8:45 am]
BILLING CODE 4141-01-M

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