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Federal Register / Vol. 70, No.

79 / Tuesday, April 26, 2005 / Notices 21431

obtained by contacting Ms. Farrar or by individuals with limited proficiency in represented and the committee’s
accessing the Web site managed by speaking the English language. function. Every effort is made to ensure
OMH at http://www.omhrc.gov/acmh. Activities under the preceding sentence that a broad representation of
SUPPLEMENTARY INFORMATION: Pursuant shall include developing and evaluating geographic areas, females, ethnic and
to Public Law 105–392, the Secretary of model projects. minority groups, and the disabled are
Health and Human Services established Management and support services for given consideration for membership on
the Advisory Committee on Minority the ACMH are provided by the OMH, DHHS Federal advisory committees.
Health (ACMH). The Committee shall which is a program office within the Appointment to this Committee shall be
provide advice to the Deputy Assistant OPHS. made without discrimination on the
Secretary for Minority Health in Nominations basis of age, race, ethnicity, gender,
carrying out the duties stipulated under sexual orientation, disability, and
Public Law 105–392. This includes The OPHS is requesting nominations cultural, religious, or socioeconomic
providing advice to improve the health for vacant positions on the ACMH. The status. Nominations must state that the
of each racial and ethnic minority group Committee is composed of 12 voting nominee is willing to serve as a member
and in the development of goals and members, in addition to non-voting ex of ACMH and appears to have no
specific activities of the OMH, which officio members. This announcement is conflict of interest that would preclude
are: seeking nominations for voting membership. An ethics review is
(1) Establish short-range and long- members. Voting members of the conducted for each selected candidate.
range goals and objectives and Committee are appointed by the Therefore, individuals selected for
coordinate all other activities within the Secretary from individuals who are not nomination will be required to provide
Public Health Service that relate to officers or employees of the Federal detailed information concerning such
disease prevention, health promotion, Government and who have expertise matters as financial holdings,
service delivery, and research regarding issues of minority health. To consultancies, and research grants or
concerning such individuals; qualify for consideration of appointment contracts to permit evaluation of
(2) Enter into interagency agreements to the Committee, an individual must possible sources of conflict of interest.
with other agencies of the Public Health possess demonstrated experience and
expertise working on issues/matters Dated: April 13, 2005.
Service;
(3) Support research, demonstrations, impacting the health of racial and ethnic Garth N. Graham,
and evaluations to test new and minority populations. The charter Deputy Assistant Secretary for Minority
stipulates that the racial and ethnic Health.
innovative models;
(4) Increase knowledge and minority groups shall be equally [FR Doc. 05–8250 Filed 4–25–05; 8:45 am]
understanding of health risk factors; represented on the Committee BILLING CODE 4150–29–P
(5) Develop mechanisms that support membership.
better information dissemination, Individuals selected for appointment
education, prevention, and service to the Committee shall be invited to DEPARTMENT OF HEALTH AND
delivery to individuals from serve four year terms. Committee HUMAN SERVICES
disadvantaged backgrounds, including members who are not officers or
employees of the United States National Institutes of Health
individuals who are members of racial
or ethnic minority groups; Government will receive a stipend for
Government-Owned Inventions;
(6) Ensure that the National Center for attending Committee meetings and
Availability for Licensing
Health Statistics collects data on the conducting other business in the
health status of each minority group; interest of the Committee, including per AGENCY: National Institutes of Health,
(7) With respect to individuals who diem and reimbursement for travel Public Health Service, DHHS.
lack proficiency in speaking the English expenses incurred. ACTION: Notice.
language, enter into contracts with Nominations should be typewritten.
public and nonprofit private providers The following information should be SUMMARY: The inventions listed below
of primary health services for the included in the package of material are owned by an agency of the U.S.
purpose of increasing the access of the submitted for each individual being Government and are available for
individuals to such services by nominated for consideration: (1) A letter licensing in the U.S. in accordance with
developing and carrying out programs to of nomination that clearly states the 35 U.S.C. 207 to achieve expeditious
provide bilingual or interpretive name and affiliation of the nominee, the commercialization of results of
services; basis for the nomination (i.e., specific federally-funded research and
(8) Support a national minority health attributes which qualify the nominee for development. Foreign patent
resource center to carry out the service in this capacity), and a statement applications are filed on selected
following: (a) Facilitate the exchange of that the nominee is willing to serve as inventions to extend market coverage
information regarding matters relating to a member of the Committee; (2) the for companies and may also be available
health information and health nominator’s name, address, and daytime for licensing.
promotion, preventive health services, telephone number, and the home and/ ADDRESSES: Licensing information and
and education in appropriate use of or work address, telephone number, and copies of the U.S. patent applications
health care; (b) facilitate access to such e-mail address of the individual being listed below may be obtained by writing
information; (c) assist in the analysis of nominated; and (3) a current copy of the to the indicated licensing contact at the
issues and problems relating to such nominee’s curriculum vitae. The names Office of Technology Transfer, National
matters; (d) provide technical assistance of Federal employees should not be Institutes of Health, 6011 Executive
with respect to the exchange of such nominated for consideration of Boulevard, Suite 325, Rockville,
information (including facilitating the appointment to this Committee. Maryland 20852–3804; telephone: 301/
development of materials for such The Department makes every effort to 496–7057; fax: 301/402–0220. A signed
technical assistance); and ensure that the membership of DHHS Confidential Disclosure Agreement will
(9) Carry out programs to improve Federal advisory committees is fairly be required to receive copies of the
access to health care services for balanced in terms of points of view patent applications.

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21432 Federal Register / Vol. 70, No. 79 / Tuesday, April 26, 2005 / Notices

Composition and Methods for Diagnosis the treatment field, resulting in scarring neuroblastoma cells also show increased
and Treatment of Metastatic Disease and, in severe cases, loss of function of expression of several pro-survival
Xin Wei Wang and Anuradha Budhu the normal tissue. Although proteins such as Bcl-2, FLIP, and AKT.
(NCI). chemotherapy can provide a therapeutic Preclinical models suggest that IFN-
U.S. Provisional Application filed 8 Mar benefit in many cancer subjects, it often gamma/TNF-alpha cytokines including
2005 (DHHS Reference No. E–127– fails to treat the disease because cancer IL–2, IL–12 and IL–18 among others
2005/0–US–01). cells may become resistant to the may have potent antitumor efficacy in
Licensing Contact: Michelle A. Booden; chemotherapeutic agent. To overcome several preclinical models, and that
301/451–7337; these limitations additional these regimens may act by inducing an
boodenm@mail.nih.gov. antineoplastic strategies, such as adaptive cell-mediated immune
enhancing the antineoplastic effect of response. Although some single agent
Liver cancer, particularly
existing therapies, are needed. cytokine regimens have achieved
hepatocellular carcinoma (HCC), is a This invention discloses a method for modest efficacy in the clinical setting,
leading cause of cancer deaths enhancing an antineoplastic effect of a the utility of some approaches has been
worldwide. In spite of recent progress in DNA-damaging therapy. The method limited overall by side effects that can
therapeutic strategies, prognosis of includes administering to a subject be associated with high-dose cytokine
patients with advanced HCC remains having a neoplasm a therapeutically therapy.
very poor. Although routine screening effective amount of the DNA-damaging The present invention describes a
of individuals at risk for developing therapy and a ribosome inhibitor that method for combining ubiquitin-
HCC may extend the life of some inhibits tyrosyl-DNA phosphodiesterase proteosome inhibitors with various
patients, many are still diagnosed with 1 (Tdp1) activity, wherein the ribosome cytokines to overcome mechanisms of
advanced HCC and have little chance of inhibitor is administered in a sufficient tumor self-defense and sensitize both
survival. A small subset of HCC patients amount to enhance the DNA-damaging tumor and/or endothelial cell
qualifies for surgical intervention, but therapy. populations to apoptosis. These
the consequent improvement in long- This disclosure also provides combination approaches may not only
term survival is only modest. The pharmaceutical compositions that offer the prospect for improved
extremely poor prognosis of HCC is include at least one chemotherapeutic therapeutic efficacy, but achieve these
largely the result of a high rate of agent and at least one ribosome effects at lower, more clinically
recurrence after surgery or of intra- inhibitor that inhibits Tdp1 activity, tolerable doses than can be achieved
hepatic metastases that develop through wherein the chemotherapeutic agent utilizing either respective agent alone. It
invasion of the portal vein or spread to and the ribosome inhibitor are present is anticipated that this therapeutic
other parts of the liver; extra-hepatic in a therapeutically effective amount for intervention could be directed towards
metastases are less common. the ribosome inhibitor to enhance an multiple human carcinomas, and
The present invention describes tools antineoplastic effect of the potentiate the efficacy of multiple
to determine a unique gene expression chemotherapeutic agent. different cytokines both in the setting of
profile present in either liver In addition to licensing, the oncology and infectious disease
parenchyma through needle biopsy or technology is available for further applications.
blood that can aid diagnosis or development through collaborative In addition to licensing, the
prognosis of HCC patients with or research opportunities with the technology is available for further
without metastatic potential. This inventors. development through collaborative
method also provides a signature- research opportunities with the
derived polymerase chain reaction or Inhibition of Proteosome Function to
inventors.
serological screening method to identify Potentiate the Proapoptotic and
drug candidates to treat metastatic or Antitumor Activity of Cytokines Methods for Inhibiting or Treating
recurrent HCC. Jon Wigginton et al. (NCI). Cancer
In addition to licensing, the U.S. Provisional Patent Application Ernest Hamel (NCI), et al.
technology is available for further filed 23 Mar 2005 (DHHS Reference U.S. Provisional Application No. 60/
development through collaborative No. E–072–2005/0–US–01). 616,347 filed 05 Oct 2004 (DHHS Ref.
research opportunities with the Licensing Contact: Michelle A. Booden; No. E–323–2004/0–US–01).
inventors. 301/451–7337; Licensing Contact: Thomas P. Clouse;
boodenm@mail.nih.gov. 301/435–4076; clouset@mail.nih.gov.
Aminoglycosides and Ribosome
Protein degradation via the ubiquitin- This invention describes novel
Inhibitors as Inhibitors of Tyrosyl-
proteosome pathway is an important arylthioindole derivatives having
DNA-Phosphodiesterase
regulator of cell cycle progression and enhanced interaction with tubulin and
Drs. Yves Pommier and Zhi-Yong Liao survival. Thus, inhibitors of this increased effectiveness in growth
(NCI). pathway can be directly cytotoxic and inhibition of MCF–7 breast cancer cells
DHHS Reference No. E–117–2005/0– can sensitize several tumor cell types to as well as other cell types. Antitubulin
US–01. cytotoxic chemotherapy and radiation. drugs have an established role in the
Licensing Contact: John Stansberry; 301/ Neuroblastoma is the most common treatment of cancer, parasitic diseases
435–5236; stansbej@mail.nih.gov. extracranial solid tumor in children, and inflammatory disorders. These new
Cancer has long been a leading cause and the development of clinical chemical compounds have the potential
of mortality in the United States. DNA- resistance to cytotoxic therapies is a to result in more effective therapeutics
damaging therapies, such as major therapeutic obstacle in these for the treatment of neoplastic,
radiotherapy and chemotherapy, are the patients. Several apoptosis inflammatory and parasitic diseases.
methods of choice for treating subjects abnormalities, which result from In addition to licensing, the
with metastatic cancer or subjects with decreased expression of pro-apoptotic technology is available for further
diffuse cancers such as leukemias. proteins, are associated with increased development through collaborative
However, radiotherapy can cause resistance to standard therapeutic research opportunities with the
substantial damage to normal tissue in interventions. In addition, inventors.

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Federal Register / Vol. 70, No. 79 / Tuesday, April 26, 2005 / Notices 21433

Regulation of ATG7 Beclin 1 Program degradation. Treatment with O6- their origin that may confer them with
of Autophagic Cell Death by Caspase-8 benzylguanine renders cell radiation a unique cellular specificity in targeted
Michael Lenardo and Yu Li (NIAID), et hypersensitive due to degradation of human gene therapy. Therefore, vectors
al. BRCA2. Radio-sensitization of tumors derived from this avian AAV are likely
U.S. Provisional Application No. 60/ by O6-benzylguanine should have a to find novel applications for gene
556,857 filed 30 May 2004 (DHHS significant impact on cancer therapy in humans and fowl.
Reference No. E–318–2004/0–US–01). therapeutics. The elucidation of the This research has been described, in
Licensing Contact: Mojdeh Bahar; 301/ mechanism of action for the part, in Bossis and Chiorini (2003) J.
435–2950; baharm@mail.nih.gov. chemotherapeutic agent O6- Virol. (77)12:6799–6810.
The invention discloses the role of benzylguanine relative to BRCA2 may
Identification of Novel Birt-Hogg-Dubé
autophagy in regulation cell death. potentially improve the success rate of
(BHD) Gene
Further it teaches a method of inducing treating BRCA2 expressing tumors.
In addition to licensing, the Laura S. Schmidt (NCI).
autophagic cell death by administering
technology is available for further U.S. Patent Application No. 10/514,744
a caspase inhibitor. The invention also
development through collaborative filed 16 Nov 2004 (DHHS Reference
discloses that autophagic cell death can
research opportunities with the No. E–190–2002/2–US–02).
be induced by caspase-8 inhibition and
inventors. Licensing Contact: John Stansberry; 301/
requires the genes ATG7 and Beclin 1.
In addition to licensing, the 435–5236; stansbej@mail.nih.gov.
Chinese Hamster Ovary Cells Resistant
technology is available for further to Colcemid With Altered beta-Tubulin Birt-Hogg-Dubé (BHD) syndrome is an
development through collaborative inherited autosomal dominant neoplasia
Michael M. Gottesman and Fernando R. syndrome characterized by benign hair
research opportunities with the
Cabral (NCI). follicle tumors and is associated with a
inventors.
DHHS Reference No. E–156–2004/0— higher risk for developing renal cancer,
Cancer Specific SPANX–N Markers Research Tool. spontaneous pneumothorax and /or
Natalay Kouprina et al. (NCI). Licensing Contact: Thomas P. Clouse; lung cysts.
DHHS Reference No. E–212–2004/0– 301/435–4076; clouset@mail.nih.gov. The present invention describes
US–01. The invention is Chinese hamster identification of the BHD syndrome
Licensing Contact: Mojdeh Bahar; 301/ ovary cells (CHO) resistant to colcemid associated germline mutations in a
435–2950; baharm@mail.nih.gov. with altered beta-tubulin. These novel human gene, herein called BHD
The invention provides SPANX–N mutants establish the essential role of gene. This gene encodes for the protein,
polypeptides, nucleic acids and tubulin in forming mitotic spindles and folliculin, functions of which remain
antibodies that could be useful for identify beta-tubulin as the target for currently unknown.
detecting and treating prostate or other colcemid toxicity. This discovery makes possible the
cancers. The SPANX–N genes are a Cloning and Characterization of an development of a diagnostic method for
family of related genes that are Avian Adeno-Associated Virus and BHD syndrome using a simple blood
expressed in normal testis and in tumor Uses Thereof test. The test is particularly useful in
cells in humans including melanoma, detecting BHD mutations in
bladder carcinomas and myelomas. The Ioannis Bossis (NIDCR). asymptomatic carriers within BHD
SPANX cancer/testis antigens thus U.S. Provisional Application No. 60/ families.
represent good candidates for diagnosis 472,066 filed 19 May 2003 (DHHS Patients with kidney tumors can be
or treatment of several cancers. Reference No. E–105–2003/0–US–01); evaluated for BHD gene mutations using
In addition to licensing, the PCT Application No. PCT/US04/ a similar genetic diagnostic test, which
technology is available for further 15534 filed 18 May 2004, which will allow for a more accurate diagnosis
development through collaborative published as WO 2005/017101 A2 on of a kidney cancer and improved patient
research opportunities with the 24 Feb 2005 (DHHS Reference No. E– prognosis. The BHD encoding sequence
inventors. 105–2003/0–PCT–02). is the third gene found to be responsible
Licensing Contact: Jesse S. Kindra; 301/ for inherited kidney cancer, and
Methods for Inhibiting or Treating 435–5559; kindraj@mail.nih.gov. mutation testing allows for a correct
Cancer Currently, adeno-associated virus diagnosis and initiation of the proper
Srividya Swaminathan, Shyam Sharan (AAV) represents the gene therapy treatment, which is different for each of
(NCI). vehicle of choice because it has many the types of kidney cancer caused by the
U.S. Provisional Application No. 60/ advantages over current strategies for three genes. Since BHD is the first gene
588,918 filed 16 Jul 2004 (DHHS therapeutic gene insertion. AAV is less found to be associated with
Reference No. E–160–2004/0–US–01). pathogenic than other virus types; stably chromophobe renal cancer or renal
Licensing Contact: Thomas P. Clouse; integrates into dividing and non- oncocytoma, this invention will enable
301/435–4076; clouset@mail.nih.gov. dividing cells; integrates at a consistent the development of specific treatments
This invention describes a novel role site in the host genome; and shows good or therapies for these particular
for BRCA2 in the repair of O6- specificity towards various cell types for histologic types of kidney cancer.
alkylguanine adducts and provides targeted gene delivery. Methods of using BHD encoding
evidence that after treatment with O6- To date, eight AAV isolates have been sequence also allows for a differential
benzylguanine, tumor cells with intact isolated and characterized, but new genetic diagnosis of spontaneous
BRCA2, are susceptible to ionizing serotypes derived from other animal pneumothorax, or collapsed lung. Since
radiations. In this invention the species may add to the specificity and collapsed lung can be caused by several
essential and novel function of BRCA2 repertoire of current AAV gene therapy factors, a BHD diagnostic test allows a
in the repair of O6-methylguanine is techniques. physician to determine predisposition
described and demonstrated. BRCA2 This invention describes vectors to and possible recurrence of additional
physically interacts with alkylated-AGT derived from an avian AAV. These spontaneous pneumothoraces due to
and undergoes repair-associated vectors have innate properties related to mutation(s) in the BHD gene.

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21434 Federal Register / Vol. 70, No. 79 / Tuesday, April 26, 2005 / Notices

The discovery should also lead to the This invention relates to compositions such as patentable material, and
development of novel pharmaceutical of Transforming Growth Factor beta personal information concerning
products and methods for treating BHD (TGF-beta) which promote repair of individuals associated with the grant
skin lesions using creams containing the tissue, particularly fibroblast cells, in applications and/or contract proposals,
BHD gene product, folliculin. Such animals and human beings. This the disclosure of which would
products and methods of treatment are invention also relates to a method of constitute a clearly unwarranted
expected to reduce the size and treating wounds by the topical or invasion of personal privacy.
appearance of the benign hair follicle systemic administration of the
tumors. compositions. The discovery of this Name of Committee: National Advisory
invention initiated a worldwide field of Council for Nursing Research.
The disclosed technology will provide
Date: May 17–18, 2005.
new and exciting methodologies to research aimed at the characterization
Open: May 17, 2005, 1 p.m. to 5 p.m.
correctly diagnose BHD syndrome and and development of TGF-beta in wound
Agenda: For discussion of program issues
should lead to the development of novel healing and disease. It is now known
and initiatives.
pharmaceutical reagents for treatment of that TGF-beta’s role in wound healing is
Place: National Institutes of Health,
BHD skin lesions as well as other skin complex. Its diverse effects on the many
Building 31, 31 Center Drive, Bethesda, MD
diseases. individual participating cell types in a
20892.
This research is also described in: MB wound are integrated into a specific Closed: May 18, 2005, 9 a.m. to 2 p.m.
Warren et al., Mod Pathol. (2004 Aug) temporal sequence of events within a Agenda: To review and evaluate grant
17(8):998–1011; ML Nickerson et al., defined tissue architecture. In addition applications and/or proposals.
Cancer Cell (2002 Aug) 2(2):157–164; B to its many roles in wound healing, Place: National Institutes of Health,
Zbar et al., Cancer Epidem. Bio. Prev. TGF-beta is also implicated in the Building 31, 31 Center Drive, Bethesda, MD
(2002 Apr) 11(4):393–400; LS Schmidt pathogenesis of diseases such as 20892.
et al., Am. J. Hum. Genet. (2001 Oct) autoimmune disease, fibrosis, and Contact Person: Mary E. Kerr, FAAN, RN,
69(4):876–882; Toro et al., Arch. cancer. PhD, Deputy Director, National Institute of
Dermatol. (1999 Oct) 135(10): 1195– Current research in TGF-beta biology Nursing, National Institutes of Health, 31
1202. is leading to the development of novel Center Drive, Room 5B–05, Bethesda, MD
In addition to licensing, the wound healing and disease therapies 20892–2178, 301/496–8230,
technology is available for further related to the growth factor and its kerrme@mail.nih.gov.
development through collaborative signaling pathways. Any member of the public interested in
research opportunities with the Dated: April 18, 2005. presenting oral comments to the committee
inventors. Steven M. Ferguson, may notify the Contact Person listed on this
Compositions Of Transforming Growth Director, Division of Technology Development notice at least 10 days in advance of the
and Transfer, Office of Technology Transfer, meeting. Interested individuals and
Factor Beta (TGF-beta) Which Promotes
National Institutes of Health. representatives of organizations may submit
Wound Healing and Methods for Their
[FR Doc. 05–8287 Filed 4–25–05; 8:45 am] a letter of intent, a brief description of the
Use
BILLING CODE 4140–01–P
organization represented, and a short
Michael Sporn et al. (NCI). description of the oral presentation. Only one
U.S. Patent No. 5,104,977, granted April representative of an organization may be
14, 1992, entitled ‘‘Purified DEPARTMENT OF HEALTH AND allowed to present oral comments and if
Transforming Growth Factor Beta’’ HUMAN SERVICES accepted by the committee, presentations
(DHHS Ref. No. E–070–1982/2-US– may be limited to five minutes. Both printed
05); National Institutes of Health and electronic copies are requested for the
U.S. Patent No. 5,656,587, granted record. In addition, any interested person
August 12, 1997, entitled ‘‘Promotion National Institute of Nursing Research; may file written comments with the
Of Cell Proliferation By Use Of Notice of Meeting committee by forwarding their statement to
Transforming Growth Factor Beta the Contact Person listed on this notice. The
Pursuant to section 10(d) of the
(TGF-Beta)’’ (DHHS Ref. No. E–070– statement should include the name, address,
Federal Advisory Committee Act, as
1982/2-US–07); and telephone number and when applicable, the
amended (5 U.S.C. appendix 2), notice business or professional affiliation of the
U.S. Patent No. 5,705,477, granted is hereby given of a meeting of the
January 6, 1998, entitled interested person.
National Advisory Council for Nursing Information is also available on the
‘‘Compositions Of Transforming Research.
Growth Factor Beta (TGF-Beta) Which Institute’s/Center’s home page: http://
The meeting will be open to the www.nih.gov/ninr/a_advisory.html, where an
Promotes Wound Healing And public as indicated below, with
Methods For Their Use’’ (DHHS Ref. agenda and any additional information for
attendance limited to space available. the meeting will be posted when available.
No. E–070–1982/2-US–08). Individuals who plan to attend and
Licensing Contact: Jesse S. Kindra; 301/ (Catalogue of Federal Domestic Assistance
need special assistance, such as sign
435–5559; kindraj@mail.nih.gov. Program Nos. 93.361, Nursing Research,
language interpretation or other
There is a continuing need for the National Institutes of Health, HHS)
reasonable accommodations, should
promotion of rapid cell proliferation at notify the Contact Person listed below Dated: April 15, 2005.
the site of wounds, burns, diabetic and in advance of the meeting. Anna Snouffer,
decubitus ulcers, and other traumata. The meeting will be closed to the Acting Director, Office of Federal Advisory
Prior to this invention, a number of public in accordance with the Committee Policy.
‘‘growth factors’’ were known to provisions set forth in sections [FR Doc. 05–8288 Filed 4–25–05; 8:45 am]
promote the rapid growth of cells. None 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
BILLING CODE 4140–01–M
of these growth factors, however, had as amended. The grant applications
been found to be pharmaceutically and/or contract proposals and the
acceptable agents for the acceleration of discussions could disclose confidential
wound healing. trade secrets or commercial property

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