76658 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Notices

Contact Person: Marcia Litwack, PhD,

Scientific Review Administrator, Center for

Scientific Review, National Institutes of

Health, 6701 Rockledge Drive, Room 4150,

MSC 7804, Bethesda, MD 20892, (301) 435–

1719.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.306, Comparative Medicine,

93.306; 93.333, Clinical Research, 93.333,

93.337, 93.393–396, 93.837–93.844, 93.846–

93.878, 93.892, 93.893, National Institues of

Helath, HHS)

Dated: November 29, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–31210 Filed 12–6–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Methods and Compositions

for the Detection and Treatment of

Insulin Dependent Diabetes

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This is notice, in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(i), that the National Institutes of

Health (NIH), Department of Health and

Human Services, is contemplating the

grant of an exclusive license worldwide

to practice the invention embodied in:

US Patent Application Serial Number

08/548,159 filed 10/95 by McClaren,

Notkins, Lan, and Li, and foreign

counterparts, and US Patent Application

Serial Number 08/514,213 filed 8/95,

and foreign counterparts, by McClaren,

Notkins, and Lan—both entitled

‘‘Methods and Compositions for the

Detection and Treatment of Insulin

Dependent Diabetes’’ to BioSeek Inc., of

New York, NY. The United States of

America is an assignee of the patent

rights to these inventions.

DATES: Only written comments and/or

application for a license which are

received by the NIH Office of

Technology Transfer on or before

February 5, 2001 will be considered.

ADDRESSES: Requests for a copy of the

patent applications, inquiries,

comments and other materials relating

to the contemplated license should be

directed to: John Rambosek, Ph.D. Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Su9ite 325, Rockville, MD

20852–3804; Email:jr312d@nih.gov;

Telephone: (301) 496–7056, ext. 270;

Facsimile: (301) 402–0220.

SUPPLEMENTARY INFORMATION: Insulindependent diabetes mellitus (IDDM)

affects close to one million people in the

United States. It is autoimmune disease

in which the immune system produces

antibodies that attack the body’s own

insulin-manufacturing cells in the

pancreas. Patients require daily

injections of insulin to regulate blood

sugar levels. The invention identifies

two proteins, named IA–2 and IA–2β,

that are important markers for type I

(juvenile, insulin-dependent) diabetes.

IA–2/IA–2β, when used in diagnostic

tests, recognized autoantibodies in 70

percent of IDDM patients. Combining

IA–2 and IA–2β with other known

markers increased the level of

identification to 90 percent of

individuals with IDDM. Moreover, the

presence of autoantiboides to IA–2 and

IA–2β in otherwise normal individuals

was highly predictive in identifying

those at risk of ultimately developing

clinical disease. It is now possible to

develop a rapid and effective test that

can screen large populations for IDDM.

In addition, IA–2 and IA–2β are

candidates for immune tolerance and

prevention of disease development. The

prospective exclusive license will be

royalty bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. The prospective

license may be limited to use of the

invention for diagnostic and therapeutic

uses in the detection and treatment of

diabetes. The prospective exclusive

license may be granted unless, within

60 days from the date of this published

Notice, NIH receives written evidence

and argument that establishes that the

grant of the license would not be

consistent with the requirements of 35

U.S.C. 209 and 37 CFR 404.7

Properly filed competing applications

for a license filed in response to this

notice will be treated as objections to

the contemplated license. Comments

and objections submitted in response to

this notice will not be made available

for public inspection, and, to the extent

permitted by law, will not be released

under the Freedom of Information Act,

5 U.S.C. 552.

Dated: November 30, 2000.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer.

[FR Doc. 00–31215 Filed 12–6–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Exclusive

License: Compositions and Methods

for the Stimulation of Proliferation and

Differentiation of Pancreatic Cells Ex

Vivo

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This notice in accordance

with 15 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i) that the National Institutes

of Health (NIH), Department of Health

and Human Services, is contemplating

the grant of an exclusive world-wide

license to practice the inventions

embodied in any U.S. patents 5,888,705

(03/30/1999) and 5,587,309 (12/24/

1996) or foreign applications

corresponding to PCT Patent

Application PCT/US95/00521, entitled

‘‘Compositions and Method of

Stimulating the Proliferation and

Differentiation of Human Fetal and

Adult Pancreatic Cells Ex Vivo’’

published as WO 95/29989 (11/09/1995)

to PanCel Corp., of California. The

prospective exclusive license may be

limited to the development of

therapeutic applications, including

compositions and methods using adult

pancreatic cells, to be used in the

treatment of diabetes.

DATES: Only written comments and/or

applications for a license which are

received by NIH on or before February

5, 2001, will be considered.

ADDRESSES: Requests for a copy of these

patent applications, inquiries, comment

and other materials relating to the

contemplated license should be directed

to Susan S. Rucker, J.D., Patent and

Licensing Specialist, Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Boulevard,

Suite 325, Rockville, Maryland 20852–

3804; telephone: 301/496–7056 ext 245;

fax: 301/402–0220. A signed

Confidentiality Agreement will be

required to receive copies of the patent

applications.

SUPPLEMENTARY INFORMATION: The

patents and patent applications describe

the use of the compound Hepatocyte

Growth Factor/Scatter Factor (HGF/SF)

for the stimulation of proliferation and

differentiation of pancreatic cells. Upon

exposure to HGF/SF the pancreatic cells

proliferate and differentiate and are able

to produce insulin. The ability to

stimulate pancreatic cells to proliferate

and differentiate into cells capable of

producing insulin may provide a means