Federal Register / Vol. 66, No. 38 / Monday, February 26, 2001 / Notices 11595

Steroidogenic acute regulatory protein

(StAR) manages acute steroidogenesis in

the adrenal cortex and gonads by

promoting the translocation of

cholesterol to the mitochondrial inner

membrane where initial steroid

biosynthesis is catalyzed. Within StAR

are StAR related lipid transfer (START)

domains which are 200–210 amino acid

motifs that occur in a remarkably wide

range of proteins involved in diverse

cell functions such as lipid transport

and metabolism, signal transduction

and transcription regulation. The closest

homolog to StAR is MLN64, with 35%

sequence identity between their START

domains.

The technology embodied in this

invention encompasses plasmids

expressing START domains of StAR and

MLN64. These fragments enable

expression of proteins for many

biochemical studies and specifically

towards cholesterol transfer in acute

steroidegenesis. Possible commercial

applications include targets for cancer

treatment to known over expressed

MLN64 in breast carcinoma.

Macromolecular Enzyme Substrates

Glen L. Hortin (CC)

DHHS Reference No. E–233–99/0 filed 31 Jul

2000

Licensing Contact: Dennis Penn; 301/496–

7056 ext. 211; e-mail: pennd@od.nih.gov

This invention discloses a new class

of reagents used to measure the activity

of enzymes. The inventor discovered

that connecting a small reagent

molecule onto a polymer that serves as

a large carrier molecule confers

advantages in the measurement of

enzyme activity. Advantages of the new

class of reagents are: (1) Better modeling

of the size of natural targets (substrates)

of many biologically important

enzymes, (2) improved specificity of

measurements, (3) ability to measure the

influence of substrates size on enzyme

activity (carrier group size can be varied

over a wide range), (4) improved

substrate solubility, and (5) the potential

for easier methods of synthesis and

purification of some enzyme substrates.

Reagents of this class can be used to

measure the activity of components

forming and breaking down blood clots,

of digestive components, of components

of the complement system, and of many

other components with essential

biological functions.

Efficient Generation of Midbrain

Neurons From Mouse Embryonic Stem

Cells

Sang-Hun Lee, Nadya Lumelsky, Lorenz

Studer and Ronald McKay (NINDS)

DHHS Reference No. E–291–99/0 filed May

1, 2000

Licensing Contact: Norbert Pontzer; 301/496–

7735, ext. 284; e-mail:

pontzern@od.nih.gov

Parkinson’s disease is a progressive

neurological disorder affecting an

estimated one million patients in the

United States. Parkinson’s disease

occurs when dopamine producing cells

in the central nervous system

degenerate. Currently patients receive

medications to treat the symptoms, but

not cure or stop the progression of the

disease. As the disease progresses the

medications usually become less

effective. One encouraging new form of

therapy replaces the lost dopamine

producing neurons with transplanted

cells. A major obstacle to cell

replacement therapy has been obtaining

sufficient dopamine producing cells.

Therapeutic or ethical problems exit for

all presently available sources of cells

for transplantation.

This invention provides a method for

efficiently generating dopaminergic

neurons from embryonic stem cells.

Embryonic cells are totipotent cells

which can proliferate indefinitely in the

undifferentiated state. A method of

generating specific differentiated cells

from embryonic stem cells thus

provides a potentially unlimited source

of those cells. A sequence of culturing

steps involving exposure to specific

neurotrophic factors and other agents

produces a high percentage of cultured

dopaminergic neurons. An unlimited

supply of dopaminergic neurons which

may be suitable for transplantation is

thus provided. Details of some aspects

of this invention can be found in Nature

Biotechnology Vol. 18, pages 675–679,

June 2000.

Methods for Delivering Biologically

Active Molecules Into Cells

Jeffrey L. Miller, Urszula Wojda, Paul K.

Goldsmith (NIDDK)

DHHS Reference Nos. E–174–98/0 filed 15

Jan 1999 and E–174–98/1 filed 14 Jan 2000

Licensing Contact: Dennis Penn; 301/496–

7056 ext. 211; e-mail: pennd@od.nih.gov

The appropriate gene therapy delivery

system depends greatly on the cells

being targeted and the means by which

delivery is anticipated. Numerous

clinical trials are currently ongoing for

gene therapy, each typically usually a

different mode of delivery. It is still too

early to determine which mode will be

approved and which will be the most

effective. The polyethylenimineDNA

(PEI–DNA) complex is known to be an

effective system for delivery of DNA. In

vitro models of a new delivery system

based on the cationic properties of PEI

have found that the cellular

incorporation is significantly enhanced

using an Avidin-PEI–DNA complex.

Experiments have shown that there is, at

a minimum, a 3x to 10x increase in the

cellular uptake of the DNA. It is

believed that this gene delivery system

can be targeted to any cell of interest. It

was demonstrated that the transfection

can be targeted to native and

biotinylated cells. For cells, with a

known surface phenotype, biotinylated

monoclonal antibodies can be attached

to specific sites and the Avidin-PEI–

DNA complex then binds and enters the

cell via endocytosis.

Alternatively, cells without a known

surface phenotype, biotin can be

covalently attached to the cell surface

and the Avidin-PEI–DNA complex is

then able to bind and carry the DNA

into the cells. This system appears to be

not only applicable to gene therapy, but

to the diagnostic market and to the

delivery of other anionic materials into

cells. This Avidin-PEI–DNA system may

find a niche market or it may become

utilitarian, such that it can be effectively

utilized in more than one gene therapy

treatment. This technology is available

for immediate licensing and

independent commercialization and/or

a Cooperative and Development

Research Agreement can be considered.

Dated: February 15, 2001.

Jack Spiegel,

Director, Division of Technology Development

and Transfer, Office of Technology Transfer,

National Institutes of Health.

[FR Doc. 01–4617 Filed 2–23–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Prospective Grant of Co-Exclusive

License: Homogeneous Tests for

Sequentially Determining Lipoprotein

Fractions

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)(1)(i), that the National

Institutes of Health (NIH), Department

of Health and Human Services, is

contemplating the grant of a coexclusive worldwide to practice the

inventions embodied in US Patent

Application Serial Number (60/136,709

(PCT/US00/14827) entitled

‘‘Homogeneous Tests for Sequentially

Determining Lipoprotein Fractions’’,

provisionally filed May 28, 1999 and

PCT filed May 26, 2000, to Genzyme

Diagnostics, having a place of business

11596 Federal Register / Vol. 66, No. 38 / Monday, February 26, 2001 / Notices

in Cambridge, Massachusetts, and J&S

Medical Associates, having a place of

business in Framingham,

Massachusetts. The United States of

America is an assignee to the patent

rights of this invention.

The contemplated co-exclusive

license may be limited to the

development of homogeneous

sequential tests for determination of

lipoprotein subfractions in biological

fluids, with applications to clinical

chemistry analyzers. The license may

not include the use for Patient-Initiated

Diagnostics (PID) in conjunction with

the SerSiteTM remote-site mailable

device or its equivalents, all covered by

claims of US Patent Number 6,036,659.

DATES: Only written comments and/or

applications for a license which are

received by he NIH Office of

Technology Transfer on or before April

27, 2001 will be considered.

ADDRESSES: Requests for a copy of the

patent application, inquiries, comments

and other materials relating to the

contemplated license should be directed

to: Uri Reichman, Ph.D., Technology

Licensing Specialist, Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Boulevard,

Suite 325, Rockville, MD 20852–3804;

Telephone: (301) 496–7056, ext. 240;

Facsimile: (301) 402–0220; E-mail:

reichman@od.nih.gov. A signed

Confidential Disclosure Agreement will

be required to receive copies of the

patent application.

SUPPLEMENTARY INFORMATION: The

measurement of the cholesterol content

of the lipoproteins subfraction in blood

has become the gold standard in the

clinical assessment of the risk of

coronary artery disease. Current

commercial tests involve two or three

separate determinations and some of

them are rather cumbersome. The

subject invention provides a new,

homogeneous assay for the sequential

determination of the HDL–C and of total

cholesterol present in blood. The test

can be performed in a single tube and

can readily lend itself to automation.

The method comprises complexing of

the non-HDL–C fraction, performing a

first measurement of the cholesterol

content of the unbound fraction,

disrupting the complex and performing

a second measurement of total

cholesterol. Subtraction of the first

reading from the second provides the

value of the cholesterol in the non-HDL

subfractions. Optionally, a triglyceride

assay can then also be performed on the

sample in the same tube.

The prospective co-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 co-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: February 15, 2001.

Jack Spiegel,

Director, Division of Technology,

Development and Transfer, Office of

Technology Transfer.

[FR Doc. 01–4618 Filed 2–23–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Office of the Secretary

Invitation for Proposals

AGENCY: Department of the Interior,

Office of the Secretary.

ACTION: Invitation for proposals.

SUMMARY: The Exxon Valdez Oil Spill

Trustee Council is asking the public,

private organizations, and government

agencies to submit proposals for

restoration of resources and services

injured by the Exxon Valdez oil spill.

The Invitation to Submit Restoration

Proposals for Federal Fiscal Year 2002,

a booklet explaining the process, is

available from the Trustee Council

office.

DATES: Proposals are due April 13, 2001.

ADDRESSES: Exxon Valdez Oil Spill

Trustee Council, 645 ‘‘G’’ Street, Suite

401, Anchorage, Alaska 99501.

FOR FURTHER INFORMATION CONTACT: The

Restoration Office, (907) 278–8012 or

toll free at (800) 478–7745 (in Alaska) or

(800) 283–7745 (outside Alaska) or via

e-mail at restoration@oilspill.state.ak.us.

SUPPLEMENTARY INFORMATION: Following

the Exxon Valdez oil spill in March

1989, a Trustee Council of three state

and three federal trustees, including the

Secretary of the Interior, was formed.

The Trustee Council prepared a

restoration plan for the injured

resources and services within the oil

spill area. The restoration plan calls for

annual work plans identifying projects

to accomplish restoration. Each year

proposals for restoration projects are

solicited from a variety of organizations,

including the public.

Dated: February 20, 2001.

Willie R. Taylor,

Director, Office of Environmental Policy and

Compliance.

[FR Doc. 01–4632 Filed 2–23–01; 8:45 am]

BILLING CODE 4310–R6–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of meeting.

SUMMARY: Pursuant to section 10(a)(2) of

the Federal Advisory Committee Act (5

U.S.C. App. I), this notice announces a

meeting of the Klamath Fishery

Management Council, established under

the authority of the Klamath River Basin

Fishery Resources Restoration Act (16

U.S.C. 460ss et seq.). The Klamath

Fishery Management Council makes

recommendations to agencies that

regulate harvest of anadromous fish in

the Klamath River Basin. The objectives

of this meeting are to hear technical

reports, to discuss and develop Klamath

fall chinook salmon harvest

management options for the 2001

season, and to make recommendations

to the Pacific Fishery Management

Council and other agencies. The

meeting is open to the public.

DATES: The Klamath Fishery

Management Council will meet from 3

p.m. to 5 p.m. on Sunday, March 4,

2001.

PLACE: The meeting will be held at the

Columbia River Doubletree Hotel, 1401

N. Hayden Island Drive, Portland,

Oregon.

FOR FURTHER INFORMATION CONTACT: Mr.

Phil Detrich, Project Leader, Fish and

Wildlife Service, 1829 South Oregon

Street, Yreka, California 96097,

telephone (530) 842–5763.

SUPPLEMENTARY INFORMATION: At the

March 4, 2001, meeting, the Klamath

Fishery Management Council may

schedule short follow-up meetings to be

held between March 5, 2001, and March

8, 2001, at the Columbia River

Doubletree Hotel, 1401 N. Hayden

Island Drive, Portland, Oregon, where

the Pacific Fishery Management Council

will be meeting. For background

information on the Klamath Council,

please refer to the notice of their initial

meeting that appeared in the Federal

Register on July 8, 1987 (52 FR 25639).