Federal Register / Vol. 66, No. 30 / Tuesday, February 13, 2001 / Notices 10025

or call non toll-free at (301) 435–2932.

You may also e-mail your request to

dr3p@nih.gov.

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received within 30

days of the date of this publication.

Dated: February 1, 2001.

Anne Thomas,

Assoc. Director, Office of Communications

and Public Liaison, National Institutes of

Health.

[FR Doc. 01–3607 Filed 2–12–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases

(NIDDK): Opportunity for Cooperative

Research and Development

Agreements (CRADAs) to Develop

Monoclonal Antibodies and/or Other

Reagents and Products for Use in

Identifying the Dombrock Blood Group

Carrier Molecule Aimed at Improving

Blood Typing Practices Through

Molecular Means

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The National Institute of

Diabetes and Digestive and Kidney

Diseases (NIDDK) of the National

Institutes of Health (NIH) is seeking

Licensee(s) and/or proposals in the form

of capability statements from potential

collaborators for a Cooperative Research

and Development Agreement (CRADA)

to develop monoclonal antibodies and/

or other reagents and products for use

in identifying the Dombrock blood

group carrier molecule. The U.S.

government-owned technology is

encompassed within U.S. Provisional

Patent Application Serial No. 60/

235,162, entitled ‘‘Identification of The

Dombrock Blood Group Glycoprotein as

a Polymorphic Member of The ADPRibosyltransferase Gene Family’’.

Pursuant to the Federal Technology

Transfer Act of 1986 (FTTA, 15 U.S.C.

3710; and Executive Order 12591 of

April 10, 1987, as amended by the

National Technology Transfer and

Advancement Act of 1995), the National

Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK) of the

National Institutes of Health (NIH) of

the Public Health Service (PHS) of the

Department of Health and Human

Services (DHHS) seeks a Cooperative

Research and Development Agreement

(CRADA) with a pharmaceutical or

biotechnology company to develop

monoclonal antibodies and/or other

reagents for use in identifying the

Dombrock blood group carrier molecule.

The goals of the CRADA include the

rapid publication of research results and

timely commercialization of products or

methods that may result from the

research.

The potential Collaborator(s)

capability statement should provide

proof of expertise in blood typing

practices through molecular means

along with a brief commercialization

plan. The NIH also will consider

proposals from Collaborators with

demonstrated expertise in developing

kits designed to identify blood group

antibodies in recipients of transfused

blood or blood products.

DATES: Only written CRADA capability

statements received by the NIDDK on or

before March 30, 2001 will be

considered during the initial design

phase; confidential information must be

clearly labeled. Potential Collaborators

may be invited to meet with the

Selection Committee at the

Collaborator’s expense to provide

additional information. The Institute

may issue an additional notice of

CRADA opportunity during the design

phase.

FOR FURTHER INFORMATION CONTACT:

Capability statements should be

submitted to Dr. Michael W. Edwards,

Office of Technology Development,

National Institute of Diabetes and

Digestive and Kidney Diseases, National

Institutes of Health, BSA Building, Suite

350 MSC 2690, 9190 Rockville Pike,

Bethesda, MD 20814–3800; Tel: 301/

496–7778, Fax: 301/402–0535; Email:

mels@nih.gov.

SUPPLEMENTARY INFORMATION: A CRADA

is an agreement designed to enable

certain collaborations between

Government laboratories and nonGovernment laboratories. It is not a

grant, and is not a contract for the

procurement of goods/services. The

NIDDK is prohibited from transferring

funds to a CRADA collaborator. Under

a CRADA, NIDDK can contribute

facilities, staff, materials, and expertise

to the effort. The collaborator typically

contributes facilities, staff, materials,

expertise, and funding to the

collaboration. The CRADA collaborator

receives an exclusive option to negotiate

an exclusive or non-exclusive license to

Government intellectual property rights

arising under the CRADA in a predetermined field of use and may qualify

as a co-inventor of new technology

developed under the CRADA.

Identification of the 25 known human

blood group molecules is of

fundamental importance for the fields of

erythroid cell biology and transfusion

medicine. The molecular description of

the ‘‘Dombrock’’ blood group system has

been determined. A candidate gene was

identified by in silico analyses of

approximately 5000 expressed sequence

tags (ESTs) from terminally

differentiating human erythroid cells.

Transfection experiments demonstrated

specific binding of anti-Dombrock and

confirmed glycosylphosphatidylinositol

membrane attachment.

Currently, reagents may not be

available to readily type all blood using

serology. The information derived by

this invention of the Dombrock blood

group carrier gene can be used to type

the human blood supply. The public

health need is to improve the blood

typing practices through molecular

means and thereby prevent clinical

problems associated with improperly

cross-matched blood.

Capability Statements

A Selection Committee will utilize the

information provided in the

‘‘Collaborator Capability Statements’’

received in response to this

announcement to help in its

deliberations. It is the intention of the

NIDDK that all qualified Collaborators

have the opportunity to provide

information to the Selection Committee

through their capability statements. The

Capability Statement should not exceed

10 pages and should address the

following selection criteria:

(1) The statement should provide

specific details of the method to be

utilized in the development of the

monoclonal antibody to the Dombrock

molecule.

(2) The statement should include a

detailed plan demonstrating the ability

to provide sufficient quantities of the

agent in a timely manner for the

duration of the study.

(3) The statement may include outline

outcome measures of interest to the

Collaborator. The specifics of the

proposed outcome measures and the

proposed support should include but

not be limited to the following:

monoclonal development expertise,

specific funding commitment to support

the advancement of scientific research,

personnel services, facilities,

equipment, or other resources that

would contribute to the conduct of the

commercial development.

(4) The statement must address

willingness to promptly publish

research results and ability to be bound

10026 Federal Register / Vol. 66, No. 30 / Tuesday, February 13, 2001 / Notices

by PHS intellectual property policies

(see CRADA: http://ott.od.nih.gov/

newpages/crada.pdf).

Licensing Information

This technology was previously

advertised in the December 26, 2000

issue of the Federal Register as a

licensing opportunity [65 FR 81532].

Briefly, the gene and its polymorphisms

that result in the Dombrock blood group

antigenicity, for the first time, provide a

route for reliable blood typing. Products

aimed at improving blood typing

practices through molecular means,

thereby preventing mismatched blood

transfusions, can also be developed with

this technology. For the sake of

completeness, the licensing contact is

provided here: John Rambosek; 301/

496–7056, ext. 270; fax: 301/402–0220;

e-mail: rambosej@od.nih.gov.

Dated: February 5, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 01–3603 Filed 2–12–01; 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.

Potentiation of Antineoplastic Agents

Using Sigma 2 Ligands

Keith W. Crawford, Wayne D. Bowen

(NIDDK)

DHHS Reference No. E–165–99/0 filed

11 May 2000

Licensing Contact: Catherine Joyce;

301/496–7735 ext. 244; e-mail:

joycec@od.nih.gov.

The inventors have developed a

therapeutic method of treating cancer

through the administration of a sigma2 receptor ligand, such as CB–184, in

combination with the anti-neoplastic

drugs, doxorubicin or actinomycin D.

The novel combination produces

marked tumor cell death at

concentrations that produce little or no

cytotoxicity when cells are exposed to

the drugs alone. The protocol may be

effective in treating tumors that are

resistant to antineoplastics alone as a

result of mutations of the p53 tumor

suppressor gene.

Tumor Markers in Ovarian Cancer

Patrice J. Morin, Colleen D. Hough,

Cheryl A. Sherman-Baust, Ellen S.

Pizer (NIA)

DHHS Reference No. E–138–00/0 filed

03 Apr 2000

Licensing Contact: Catherine Joyce;

301/496–7735 ext. 244; e-mail:

joycec@od.nih.gov.

This invention relates generally to the

identification of ovarian tumor markers

and diagnostic, prognostic and

therapeutic methods for their use. The

invention is based on the identification

of a series of ovarian tumor marker

genes that are highly expressed in

ovarian epithelial tumor cells and are

minimally expressed in normal ovarian

epithelial cells.

Imidazoacridones With Anti-Tumor

Activity

Cholody et al. (NCI)

DHHS Reference No. E–289–99/0 filed

07 March 2000

Licensing Contact: Girish Barua; 301/

496–7735 ext. 263; e-mail:

baruag@od.nih.gov.

The present invention relates to novel

bifunctional molecules with anti-tumor

activity. These agents are composed of

an imidazoacridone moiety linked by a

nitrogen containing aliphatic chain of

various length and rigidity to another

aromatic ring system capable of

intercalation to DNA.

Previous studies on related

symmetrical bis-imidazoacridones

revealed that only one planar

imidazoacridone moiety intercalates

into DNA. The second aromatic moiety

which is crucial for biological activity

resides in DNA groove, and is believed

to interact with DNA-binding proteins

(most likely, transcription factors). It

was hypothesized that action of bisimidazoacridone constitute a new

paradigm of how small molecules can

interfere with gene transcription.

To enhance the biological activity, the

inventors have developed

unsymmetrical compounds in which

one imidazoacridone system with

relatively poor DNA-intercalating

properties was replaced with much

stronger intercalators, such as 3-chloro7-methoxyacridine or naphthalimide

moieties. These new compounds,

especially those containing

naphthalimide moiety are extremely

cytotoxic against variety of tumor cells

in vitro ( IC50 at low nanomolar range)

and kill tumor cells by inducing

apoptosis. In vivo, in nude mice

xenografted with human tumors, the

compounds significantly inhibited

growth of such tumors as colon tumor

HCT116 and Colo205 as well pancreatic

tumors (lines 6.03 and 10.05 freshly

established from a patient).

Dated: February 6, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 01–3604 Filed 2–12–01; 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 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