Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Notices 75723

Institute (NHLBI), the National

Institutes of Health (NIH) will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection

Title: The Cardiovascular Health

Study. Type of Information Request:

Revision. (OMB No. 0925–0334). Need

and Use of Information Collection: This

study will quantify associations

between conventional and hypothetical

risk factors and coronary heart disease

(CHD) and stroke in people age 65 years

and older. The primary objectives

include quantifying associations of risk

factors with subclinical disease,

characterize the natural history of CHD,

stroke and identify factors associated

with clinical course. The findings will

provide important information on

cardiovascular disease in an older U.S.

population and lead to early treatment

of risk factors associated with disease

and identification of factors which may

be important in disease prevention.

Frequency of Response: twice a year

(participants) or once per cardiovascular

disease event (proxies and physicians);

Affected Public: Individuals. Types of

Respondents: Individuals recruited for

CHS and their selected proxies and

physicians. The annual reporting

burden is as follows: Estimated Number

of Respondents: 4,606; Estimated

Number of Responses per respondent:

4.55; and Estimated Total Annual

Burden Hours Requested: 1,719.

There are no capital, operating, or

maintenance costs to report.

Type of respondents

Estimated

number of

respondents

Estimated

number of responses per

respondent*

Average burden

hours per

response

Estimated total

annual burden

hours

requested

Participants .................................................................................................. 3,580 5.6 0.25 1,665

Physicians .................................................................................................... 606 1.0 0.10 20

Participant proxies ....................................................................................... 420 1.0 0.25 35

Total .................................................................................................. 4,606 4.55 0.246 1,719

*Total for 3 years.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information will

have practical utility; (2) The accuracy

of the agency’s estimate of burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) Ways to minimize the

burden of collection of information on

those who are to respond, including the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

data collection plans and instruments,

contact Dr. Diane Bild, Division of

Epidemiology and Clinical

Applications, Epidemiology and

Biometry Program, NHLBI, NIH, II

Rockledge Centre, 6701 Rockledge

Drive, MSC 7934, Bethesda, MD 20892–

7934, or call non-toll-free number (301)

435–0707, or e-mail your request,

including your address to: bild@nih.gov.

DATES: Comments Due Date: Comments

regarding this information collection are

best assured of having their full effect if

received on or before February 2, 2001.

Dated: November 16, 2000.

Peter Savage,

Acting Director, Division of Epidemiology and

Clinical Applications, National Heart, Lung,

and Blood Institute.

[FR Doc. 00–30713 Filed 12–1–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies of the U.S.

Government and are available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for companies and may also be available

for licensing.

ADDRESSES: Licensing information and

copies of the U.S. patent applications

listed below may be obtained by writing

to the indicated licensing contact at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; telephone: 301/

496–7057; fax: 301/402–0220. A signed

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

NAG–1: A Non-Steroidal AntiInflammatory Drug Related Gene

Which Has Anti-Tumorigenic

Properties

Thomas E. Eling, Seung Joon Baek

(NIEHS)

DHHS Reference No. E–170–00/0 filed

08 Sep 2000

Licensing Contact: Richard Rodriguez;

301/496–7056 ext. 287; e-mail:

rodrigur@od.nih.gov

Non-steroidal anti-inflammatory

drugs (NSAIDs) are widely used in the

treatment of inflammatory disease, and

their anti-inflammatory effects are

believed to result from their ability to

inhibit the formation of prostaglandins

by prostaglandin H synthase (COX).

Two forms of prostaglandin H have been

identified, COX–1 and COX–2. The

former seems to be constitutively

expressed in a variety of tissues while

the high expression of the latter has

been reported in colorectal tumors.

NSAIDs have been shown to be effective

in reducing human colorectal cancers

and possibly breast and lung cancers.

While the exact mechanism(s) by which

NSAIDs function has not been

elucidated, they could potentially play

a critical role in detecting, diagnosing

and treating inflammatory diseases as

well as cancer. The present invention

relates to screening methods for the

identification of agonistic and/or

antagonistic agents for the activation of

the promoter region of NAG–1.

Additional claims are directed to 1) the

75724 Federal Register / Vol. 65, No. 233 / Monday, December 4, 2000 / Notices

DNA sequence of NAG–1, 2)

compositions containing the NAG–1

sequence and 3) methods for treating

cancer patients using NAG–1.

Novel MHC Class II Restricted T Cell

Epitopes from the Cancer Antigen, NY–

ESO–1

DHHS Reference No. E–090–00/0 filed

28 Jan 2000 and

MHC Class II Restricted CD4+ T Cell

Epitopes From NY–ESO–1 Presented by

DP

DHHS Reference No. E–227–00/0 filed

29 Sep 2000

Wang et al. (NCI)

Licensing Contact: Elaine White: 301/

496–7056 ext. 282; e-mail:

gesee@od.nih.gov

NY–ESO–1 is a known tumor antigen

which is expressed on a broad range of

tumor types, including melanoma,

breast, bladder, ovarian, prostate, head

and neck cancers, neuroblastoma, and

small cell lung cancer. The abovereferenced inventions embody the

identification of a number of novel

immunogenic peptide epitopes, and

analogs thereof, which are derived from

the NY–ESO–1 tumor antigen.

DHHS Reference No. E–090–00/0

serves to identify novel MHC Class II

restricted epitopes of NY–ESO–1 which

are recognized by CD4+ T cells. DHHS

Reference No. E–227–00/0 embodies the

identification of two additional

immunogenic peptide epitopes of NY–

ESO–1. The latter two epitopes are

presented by HLA–DP4, a prevalent

MHC Class II allele present in 43–70%

of Caucasians. The inventors also

determined that the DP allele is highly

associated with the NY–ESO–1 antibody

production. In addition, one of these

epitopes has dual HLA A2 and DP4

specificity, thereby has the potential to

generate both CD4+ and CD8+ tumor

specific T cells. These epitopes may be

of great value as prophylactic and/or

therapeutic cancer vaccines for use

against a number of common cancers.

T-Cell Epitope of MAGE–12 and

Related Nucleic Acids, Vectors, Cells,

Compositions, and Methods of Inducing

an Immune Response to Cancer

Monica Panelli, Francesco Marincola,

Maria Bettinotti (NCI)

DHHS Reference No. E–056–00/0 filed

03 Mar 2000

Licensing Contact: Elaine White; 301/

496–7056 ext. 282; e-mail:

gesee@od.nih.gov

The current invention embodies the

identification of a T-cell epitope from

the cancer-specific antigen MAGE–12.

The MAGE family of genes encodes

human tumor specific antigens (TSA),

and various genes of this family are

expressed by tumors of different

histologies (melanoma, lung, colon,

breast, laryngeal cancer, sarcomas,

certain leukemias) and not by normal

cells (except testis and placenta). The

MAGE–12 peptide which is the subject

of the current invention is a specific

epitope within MAGE–12 (residues170–

178) which is recognized by tumor

infiltrating lymphocytes in the context

of HLA–Cw0702 (a common HLA type

in the Caucasian population). This Tcell epitope is advantageous in that it

represents a novel tumor rejection

antigen for use as a peptide vaccine

against melanoma or other cancer types

expressing MAGE–12 and may therefore

be of great value for use in cancer

immunotherapy.

Secreted Frizzled Related Protein,

sFRP, Fragments and Methods of Use

Thereof

JS Rubin, A Uren (both of NCI), and F

Reichsman, S Cumberledge

Serial No. 09/546,043 filed 10 April 00

Licensing Contact: Susan S. Rucker;

301/496–7056 ext 245; e-mail:

ruckers@od.nih.gov

This application relates to signal

transduction pathways and

mechanisms. More particularly, the

application describes various active

fragments of the secreted Wnt binding

protein sFRP–1 (secreted Frizzled

Related Protein-1). The sFRP–1

fragments described are capable of

binding to Wnt and therefore are able to

modulate Wnt activity. The fragments

may or may not contain the cysteine

rich domain (CRD) of sFRP–1 suggesting

that the CRD is not essential for Wnt

binding. In addition, in contrast to

earlier findings employing higher levels

of sFRP–1, the ability of sFRP–1 to

enhance Wnt signaling at low levels is

also described suggesting biphasic

regulation of Wnt signaling by sFRP–1.

The sFRP–1 fragments described herein

may be useful in the further study of

Wnt signaling as well as targets for the

development of small molecules which

can modulate Wnt signaling. PHS also

owns additional intellectual property

related to sFRP–1 which is described in

US Patent Application Serial Number

09/087,031 and which has been

published as WO 98/54325 (12/03/

1998).

This work has appeared, in part, in

Uren, A et al. JBC 275(6): 4374–4382

(Feb 11, 2000).

Dated: November 22, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 00–30714 Filed 12–1–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The invention listed below is

owned by an agency of the U.S.

Government and is available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of federally

funded research and development.

ADDRESSES: Licensing information and a

copy of the U.S. patent application

referenced below may be obtained by

contacting J. R. Dixon, Ph.D., at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7056 ext 206; fax 301/402–0220; email: jd212g@nih.gov). A signed

Confidential Disclosure Agreement is

required to receive a copy of any patent

application.

Entitled: ‘‘Discovery of Gene

Expressed in Many Cancers and Only

Normal Testis’’

Inventors: Drs. Ira H. Pastan (NCI),

Xiu F. Liu (NCI), Byungkook Lee (NCI)

and Lee J. Helman (NCI).

DHHS Ref. No. E–161–00/0 Filed:

September 1, 2000.

Large numbers of expressed sequence

tags (EST’s) have been cloned from

various normal and cancer tissues.

Cancer-testis antigens are a distinct

class of differentiation antigens that

have a restricted pattern of expression

in normal tissues. These genes are

primarily expressed in the primitive

germ cells, spermatogonia, in the

normal testis. Malignant transformation

is often associated with activation or

derepression of silent Cancer-testis

genes, and this results in the expression

of Cancer-testis antigen in a variable

proportion of a wide range of human

tumors. Three related genes, termed

XAGEs, were recently identified by

homology walking using the dbEST

database.

The XAGE–1 gene is a human Xlinked gene that is strongly expressed in