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Federal Register / Vol. 72, No.

166 / Tuesday, August 28, 2007 / Notices 49289

form of identification (for example, a Place: National Library of Medicine, assigned to the United States of America
government-issued photo ID, driver’s license, Building 38, 2nd Floor, Board Room, 9000 (PHS ref E–324–2001/0,1).
or passport) and to state the purpose of their Rockville Pike, Bethesda, MD 20894.
DATE: Only written comments and/or
visit. Contact Person: Arthur A. Petrosian, PhD,
Scientific Review Administrator, Division of application for a license that are
(Catalogue of Federal Domestic Assistance received by the NIH Office of
Program Nos. 93.879, Medical Library Extramural Programs, National Library of
Medicine, 6705 Rockledge Drive, Suite 301, Technology Transfer on or before
Assisance, National Institutes of Health,
Bethesda, MD 20892–7968, 301–496–4253, October 29, 2007 will be considered.
HHS)
petrosia@mail.nih.gov. ADDRESS: Requests for a copy of the
Dated: August 22, 2007. Any interested person may file written patent application, inquiries, comments
Jennifer Spaeth, comments with the committee by forwarding and other materials relating to the
the statement to the contact Person listed on
Director, Office of Federal Advisory
this notice. The statement should include the
contemplated license should be directed
Committee Policy. to: Cristina Thalhammer-Reyero, Ph.D.,
name, address, telephone number and when
[FR Doc. 07–4215 Filed 8–27–07; 8:45 am] applicable, the business or professional M.B.A., Office of Technology Transfer,
BILLING CODE 4140–01–M affiliation of the interested person. National Institutes of Health, 6011
In the interest of security, NIH has Executive Boulevard, Suite 325,
instituted stringent procedures for entrance Rockville, MD 20852–3804; e-mail:
DEPARTMENT OF HEALTH AND onto the NIH campus. All visitor vehicles, ThalhamC@mail.nih.gov; Telephone:
HUMAN SERVICES including taxicabs. hotel, and airport shuttles 301–435–4507; Facsimile: 301–402–
will be inspected before being allowed on 0220.
National Institutes of Health campus. Visitors will be asked to show one
form of identification (for example, a SUPPLEMENTARY INFORMATION: The
National Library of Medicine; Notice of government-issued photo ID, driver’s license, prospective exclusive license will be
or passport) and to state the purpose of their royalty bearing and will comply with
Closed Meetings visit. the terms and conditions of 35 U.S.C.
Pursuant to section 10(d) of the (Catalogue of Federal Domestic Assistance 209 and 37 CFR 404.7. The prospective
Program Nos. 93.879, Medical Library exclusive license may be granted unless,
Federal Advisory Committee Act, as Assistance, National Institutes of Health,
amended (5 U.S.C. Appendix 2), notice within 60 days from the date of this
HHS)
is hereby given of the following published Notice, NIH receives written
Dated: August 22, 2007. evidence and argument that establishes
meetings.
Jennifer Spaeth, that the grant of the license would not
The meetings will be closed to the Director, Office of Federal Advisory be consistent with the requirements of
public in accordance with the Committee Policy. 35 U.S.C. 209 and 37 CFR 404.7.
provisions set forth in sections [FR Doc. 07–4223 Filed 8–27–07; 8:45 am] The invention relates to a method of
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., using supervised pattern recognition
BILLING CODE 4140–01–M
as amended. The grant applications and methods for classifying, diagnosing,
the discussions could disclose predicting, or prognosticating various
confidential trade secrets or commercial DEPARTMENT OF HEALTH AND diseases. The method includes
property such as patentable material, HUMAN SERVICES obtaining high dimensional
and personal information concerning experimental data, such as gene
individuals associated with the grant National Institutes of Health expression profiling data, filtering the
applications, the disclosure of which data, reducing the dimensionality of the
would constitute a clearly unwarranted Prospective Grant of Exclusive data through use of one or more
invasion of personal privacy. License: FDA Cleared Pediatric Cancer methods, training artificial neural
Name of Committee: National Library of Diagnostics and Prognostics networks (ANN, a supervised pattern
Medicine Special Emphasis Panel; G08–R01– AGENCY: National Institutes of Health, recognition method), ranking individual
R21. Public Health Service, HHS. data points from the data, choosing
Date: October 15, 2007. multiple data points from the data based
ACTION: Notice.
Time: 1 p.m. to 4:30 p.m. on the relative ranking, and using the
Agenda: To review and evaluate grant SUMMARY: This is notice, in accordance multiple data points to determine if an
applications.
with 35 U.S.C. 209(c)(1) and 37 CFR unknown set of experimental data
Place: National Library of Medicine, 6705
Rockledge Drive, Suite 301, Bethesda, MD
404.7(a)(1)(I), that the National indicates a diseased condition, a
20817 (Telephone Conference Call). Institutes of Health (NIH), Department predilection for a diseased condition, or
Contact Person: Zoe E. Huang, MD, Health of Health and Human Services, is a prognosis about a diseased condition.
Scientific Administrator, Extramural contemplating the grant of an exclusive Further, the invention relates to sets of
Programs, National Library of Medicine, license to practice the invention genes expressed in cancer cells that
Rockledge 1 Building, 6705 Rockledge Drive, embodied in Patent Applications U.S. function to characterize each cancer
Suite 301, Bethesda, MD 20892–7968, 301– 10/133,937, filed 04/25/2002, entitled type, and methods of using the sets of
594–4937, huangz@mail.nih.gov. ‘‘Methods for Analyzing High genes for diagnosis and for targeting the
Name of Committee: Biomedical Library Dimensional Data for Classifying, therapy of selected cancers. In
and Informatics Review Committee. Diagnosing, Prognosticating and/or particular, the methods apply to classify
Date: November 6–7, 2007. Predicting Diseases and Other Biological cancers which often present diagnostic
Time: November 6, 2007, 8 a.m. to 6 p.m. States’’; and U.S. 10/159,563, filed 05/ dilemmas in clinical practice, such as
Agenda: To review and evaluate grant 31/2002, entitled ‘‘Selections of Genes the pediatric small round blue cell
applications.
And Methods of Using The Same For tumors (SRBCTs), including
pwalker on PROD1PC71 with NOTICES

Place: National Library of Medicine,


Building 38, 2nd Floor, Board Room, 9000 Diagnosis And For Targeting The neuroblastoma (NB),
Rockville Pike, Bethesda, MD 20894. Therapy of Select Cancers’’; to Althea rhabdomyosarcoma (RMS), Burkitt’s
Time: November 7, 2007, 8 a.m. to 2 p.m. Technologies, Inc. having a place of lymphoma (BL), and the Ewing family
Agenda: To review and evaluate grant business in San Diego, California. The of tumors (EWS). Specifically, the
applications. patent rights in this invention have been invention is an application of ANNs for

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49290 Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Notices

the diagnostic classification of cancers Redox Status of a Tissue’’ (Inventors: Dr that the grant of the license would not
based on gene expression profiling data James Mitchell et al.) to Mitos be consistent with the requirements of
derived from cDNA microarrays. The Pharmaceutical, Inc. (hereafter Mitos), 35 U.S.C. 209 and 37 CFR 404.7.
ANNs were first trained to be used as having a place of business in Newport The field of use may be limited to
models, and then correctly classified all Beach, California. The patent rights in methods for determining the redox
samples tested and identified the genes these inventions have been assigned to status of tissues by utilizing nitroxide
most relevant to the classification. Their the United States of America. contrast agents in combination with
study demonstrated the potential DATES: Only written comments and/or MRI for diagnosis of cancer and other
applications of these methods for tumor application for a license, which are pathologies.
diagnosis and for the identification of received by the NIH Office of Properly filed competing applications
candidate targets for therapy. The Technology Transfer on or before for a license filed in response to this
uniqueness of this method is taking October 29, 2007 will be considered. notice will be treated as objections to
gene expression data generated by ADDRESSES: Requests for a copy of the the contemplated license. Comments
microarrays, minimizing the genes from patent application, inquiries, comments and objections submitted in response to
the original 1000s to less than 100, and other materials relating to the this notice will not be made available
identifying which genes are the most contemplated license should be directed for public inspection, and, to the extent
relevant to a classification, which gives to: Chekesha Clingman, PhD, Office of permitted by law, will not be released
an immediate clue to the actual Technology Transfer, National Institutes under the Freedom of Information Act,
biological processes involved, not just of Health, 6011 Executive Boulevard, 5 U.S.C. 552.
surrogate markers which have no Suite 325, Rockville, MD 20852–3804; Dated: August 20, 2007.
bearing on the biology. e-mail: clingmac@mail.nih.gov; Steven M. Ferguson,
The field of use may be limited to Telephone: (301) 435–5018; Facsimile: Director, Division of Technology Development
‘‘FDA Cleared Pediatric Cancer (301) 402–0220. and Transfer, Office of Technology Transfer,
Diagnostics and Prognostics’’. SUPPLEMENTARY INFORMATION: The National Institutes of Health.
Properly filed competing applications present invention relates to a method of [FR Doc. E7–16931 Filed 8–27–07; 8:45 am]
for a license filed in response to this determining the redox status of tissues BILLING CODE 4140–01–P
notice will be treated as objections to by administering a cell-permeable
the contemplated license. Comments nitroxide, such as 4-hydroxy-2,2,6,6-
and objections submitted in response to tetramethylpiperidine-1-oxyl (or DEPARTMENT OF HEALTH AND
this notice will not be made available Tempol), as a contrast agent and HUMAN SERVICES
for public inspection, and, to the extent employing magnetic resonance imaging
permitted by law, will not be released (MRI). Also provided by the invention National Institutes of Health
under the Freedom of Information Act, are a method for diagnosing a tumor and
5 U.S.C. 552. Policy for Sharing of Data Obtained in
other pathologies associated with NIH Supported or Conducted Genome-
Dated: August 20, 2007. oxidative stress and a method for Wide Association Studies (GWAS)
Steven M. Ferguson, determining a cancer treatment
Director, Division of Technology Development protocol. Tumor tissues exhibit viable AGENCY: National Institutes of Health,
and Transfer, Office of Technology Transfer, but hypoxic regions that allow them to HHS.
National Institutes of Health. reduce nitroxide compounds more ACTION: Notice.
[FR Doc. E7–16930 Filed 8–27–07; 8:45 am] efficiently than normal tissue. The
BILLING CODE 4140–01–P paramagnetic relaxivity of nitroxide Background
compounds makes it possible to use The NIH is interested in advancing
standard MRI scanners to determine the genome-wide association studies
DEPARTMENT OF HEALTH AND redox status of tissue in vivo. By (GWAS) to identify common genetic
HUMAN SERVICES determining the redox status of a tumor factors that influence health and
it is possible to not only diagnose a disease. For the purposes of this policy,
National Institutes of Health tumor due to its enhanced reduction of a genome-wide association study is
intracellular nitroxide contrast agent, defined as any study of genetic variation
Prospective Grant of Exclusive
but also to determine appropriate across the entire human genome that is
License: Method for Determining the
radiation treatment fields spatially to designed to identify genetic associations
Redox Status of a Tissue
deliver therapeutic doses of radiation, with observable traits (such as blood
AGENCY: National Institutes of Health, and to determine appropriate timing pressure or weight), or the presence or
Public Health Service, HHS. sequences after the administration of a absence of a disease or condition.1
ACTION: Notice. nitroxide contrast agent such that the Whole genome information, when
maximum difference between normal combined with clinical and other
SUMMARY: This is notice, in accordance and tumor tissue with respect to the phenotype data, offers the potential for
with 35 U.S.C. 209(c)(1) and 37 CFR radioprotective form of the nitroxide is increased understanding of basic
404.7(a)(1)(I), that the National present in the normal tissue, thereby biological processes affecting human
Institutes of Health (NIH), Department limiting collateral damage to the normal health, improvement in the prediction
of Health and Human Services, is tissue. of disease and patient care, and
contemplating the grant of an exclusive The prospective exclusive license will
license to practice the inventions be royalty bearing and will comply with 1 To meet the definition of a GWAS, the density
embodied in: PCT Application No. PCT/ the terms and conditions of 35 U.S.C.
pwalker on PROD1PC71 with NOTICES

of genetic markers and the extent of linkage


US2006/031208 (E–258–2005/0–PCT– 209 and 37 CFR 404.7. The prospective disequilibrium should be sufficient to capture (by
02) filed August 10, 2006 claiming exclusive license may be granted unless, the r2 parameter) a large proportion of the common
variation in the genome of the population under
priority to U.S. Provisional Application within 60 days from the date of this study, and the number of samples (in a case-control
No. 60/707,518 (E–258–2005/0–US–01), published Notice, NIH receives written or trio design) should provide sufficient power to
titled ‘‘Method for Determining the evidence and argument that establishes detect variants of modest effect.

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