51628 Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / 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 

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] 

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 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 

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 

National Institutes of Health 

National Center on Minority Health and 

Health Disparities; Amended Notice of 

Meeting 

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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Notices 51629 

1The 2003 NIH Data Sharing Policy applies to 

investigators seeking $500,000 or more in direct 

costs in any year (http://grants2.nih.gov/grants/ 

policy/data_sharing/data_sharing_guidance.htm). 

2Request for Information on Modifications to the 

NHLBI Policy for Distribution of Data from Clinical 

Trials and Epidemiology Studies (http:// 

www.nhlbi.nih.gov/funding/policies/rfigenome.htm), 2006. 

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) 

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 

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: http:// 

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 http://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 

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 


jlentini on PROD1PC65 with NOTICES