Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Notices 14955

resources and scientific expertise to a

project aimed at identifying

mechanisms responsible for abnormal

melanocyte function in clinical

hyperpigmentary conditions. Little is

known about the level of abnormal

function of melanocytes in a number of

clinical conditions of

hyperpigmentation, such as occurs in

postinflammation, wound healing and/

or photodamaged/age pigmented

lesions. This proposed study will

employ a number of antibodies specific

for melanogenic proteins to examine

melanocyte function, and thus levels of

melanogenic protein expression, in such

lesions. DNA probes specific for the

encoding genes will be used to

characterize the level of abnormal

regulation of any gene products so

identified. Approaches will be designed

to attempt to correct abnormal

expression of such genes, or the

function of their encoded proteins and

thus down-regulate pigmentation in

vitro, with the ultimate goal of

developing commercially useful

therapeutic agents to treat conditions of

epidermal hyperpigmentation. Since

pigment production is inherently

associated with photoprotection against

UV-induced carcinogenesis, further

benefit of these studies towards

photoprotection may evolve. The

CRADA will allow the selected partner

to provide expertise and resources, in

collaboration with NCI, for the

preclinical development of agents useful

in the treatment of epidermal

hyperpigmentary conditions. Further

clinical development of such agents

may also be made subject to this

agreement, or a separate agreement at a

later date, and upon mutual agreement

of the parties.

The expected duration of the CRADA

will be three (3) to five (5) years.

The role of the National Cancer

Institute, the Division of Cancer Biology,

Diagnosis and Centers includes:

1. NCI will provide specific antibodies

and probes useful to examine

expression of pigmentary genes in

hyperpigmented tissues.

2. NCI will perform enzymatic assays

that measure melanogenic protein

function in hyperpigmented tissues.

3. NCI will examine melanocyte

function via expression of pigmentary

genes in hyperpigmentary lesions.

4. NCI will screen potential inhibitors or

down-regulators of melanogenic

activity using in vitro techniques with

melanocytes in culture.

5. NCI will collaborate with the

corporate partner on the design of

experiments and evalutation of

results.

The role of the successful corporate

partner will include:

1. Supply expertise in melanocyte

function in hyperpigmentary

disorders.

2. Supply potential melanogenic

inhibitors or down-regulators of

melanogenic activity for testing.

3. Provide funds to support a

postdoctoral fellow and associated

expenses of the study.

4. The corporate partner will collaborate

with the NCI on the design of

experiments and the evaluation of

results.

Criteria for choosing the collaborating

company will include:

1. Experience in the study of

hyperpigmentary disorders.

2. Ability to provide adequate amounts

of potential melanogenic inhibitors or

down regulators of melanogenic

activity for the preclinical studies

which are subject to the research plan.

3. Experience and ability to produce,

package, market and distribute

pharmaceutical and/or cosmetic

products, including experience with

the regulatory approval process and

with the FDA.

4. Willingness to cooperate with the NCI

in the collection, evaluation,

maintenance and publication of data

from the investigation.

5. Willingness to share costs of the

laboratory studies.

6. An agreement to be bound by DHHS

rules involving the use of human and

animal subjects, and human tissue.

7. Provisions for equitable distribution

of patent rights to any inventions.

Generally the rights of ownership are

retained by the organization which is

the employer of the inventor, with (1)

an irrevocable, nonexclusive, royaltyfree license to the Government (when

a company employee is the sole

inventor) or (2) an option to negotiate

an exclusive or nonexclusive license

to the company on terms that are

appropriate (when the Government

employee is the sole inventor or

where a joint invention arises)

Thomas Mays,

Director, Office of Technology Development,

National Cancer Institute.

[FR Doc. 95–6855 Filed 3–20–95; 8:45 am]

BILLING CODE 4140–01–P

National Institute of Environmental

Health Sciences: Opportunity for a

Cooperative Research and

Development Agreement (CRADA) and/

or Licensing Opportunity for

Preparative Two Dimensional Gel

Electrophoresis System

AGENCY: National Institute of

Environmental Health Sciences,

National Institutes of Health, PHS,

DHHS.

ACTION: Notice.

SUMMARY: The National Institutes of

Health (NIH) is seeking CRADA partners

and/or licensees for the further

development, evaluation, and

commercialization of a Preparative Two

Dimensional Gel Electrophoresis System

(U.S. Patent Application Serial No. 08/

243,643, filed May 16, 1994) for protein

analysis and characterization. The

National Institute of Environmental

Health Sciences has also determined

that the developed technology can be

utilized in other scientific areas. The

invention claimed in the abovereferenced patent application is

available for either further development

under a CRADA and/or exclusive or

non-exclusive licensing (in accordance

with 35 U.S.C 207 and 37 CFR part 404)

for the applications described below

under SUPPLEMENTARY INFORMATION.

ADDRESSES: CRADA proposals and

questions about this opportunity may be

addressed to Dr. B. Alex Merrick,

NIEHS, Mail Drop D4–03, P.O. Box

12233, Research Triangle Park, NC

27709 (Telephone: 919/541–1531; Fax:

919/541–4704; Email:

MERRICK@NIEHS.NIH.GOV). CRADA

proposals must be received by the date

specified below.

Licensing proposals and questions

about this opportunity should be

addressed to: David Sadowski, Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Boulevard,

Rockville, MD 20852 (Telephone: 301/

496–7735 ext. 288; Fax: 301/402–0220).

Information on the patent application

and pertinent information not yet

publicly described can be obtained

under a Confidential Disclosure

Agreement. Respondees interested in

licensing the invention(s) will be

required to submit an Application for

License to Public Health Service

Inventions. Respondees interested in

submitting a CRADA proposal should be

aware that it may be necessary to secure

a license to the above patent rights in

order to commercialize products arising

from a CRADA agreement.

DATES: Capability statements/CRADA

proposals must be received by NIH on

or before May 22, 1995. There is no
14956 Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Notices

deadline by which license applications

must be received.

SUPPLEMENTARY INFORMATION:

The National Institute of

Environmental Health Sciences has

developed procedures and a prototype

device for isolation of proteins from

complex mixtures for protein

sequencing. The system serves as a onestep purification method for isolation of

biologically relevant proteins affected

by disease or experimental treatment

and has been described in

Electrophoresis 15,535–545,1994. The

system includes a preparative isoelectric

focusing device for separation of

proteins by charge, a glass mold for

preparative polyacrylamide gel

separation by mass and a protocol for

use.

The commercial advantage of the

Preparative Two Dimensional Gel

Electrophoresis system is to separate

and isolate sufficient amounts of

individual protein for sequencing in a

powerful one-step purification method.

The Preparative Two Dimensional Gel

Electrophoresis system can resolve

individual proteins by charge and mass

from up to 1 to 2 mg of unpurified

starting material from protein mixtures.

Current devices for two dimensional gel

electrophoresis are generally for

analytical scale work and are not

physically or procedurally adapted to

accommodate preparative sample loads.

Although other preparative

electrophoresis devices do exist, they

separate by either mass or charge alone

and function as stand-alone units

without ready integration into

additional systems for resolution of

individual proteins.

The developed technology has

applications for protein sequencing,

protein immunization for antibody

production, immunostaining and other

modes of protein characterization.

Although the system has been tested

and is operational, some refinements in

protein resolution are still possible

which may involve procedural, reagent

or equipment modifications.

The CRADA awardees will have an

option to negotiate for an exclusive

license to market and commercialize

any new technology developed within

the scope of the CRADA research plan

for the Preparative Two Dimensional

Gel Electrophoresis System. This

CRADA may be directed toward the codevelopment of improved preparative

electrophoresis equipment and

pertinent procedures.

Roles of NIEHS

1. Provide design and specifications

of an operating prototype device,

provide a protocol for prototype

operation, provide user expertise, and

assist in beta testing.

2. Work cooperatively with the

company(s) to determine the market

potential for the Preparative Two

Dimensional Gel Electrophoresis system

and to refine the prototype system.

Roles of the CRADA Partner

1. Provide expertise in application

and commercial-oriented separation

systems.

2. Develop plan for production,

testing and commercialization of

Preparative Two Dimensional Gel

Electrophoresis system.

Selection criteria for choosing the

CRADA partner(s) will include, but will

not be limited to the following:

1. Experience in manufacturing

electrophoresis devices or related

separation technologies.

2. Capability to develop, implement

and manage the product

commercialization so as to ensure the

dissemination of the technology(s) to

research or health care services.

3. Ability to cost share for production

and testing of a preparative twodimensional gel electrophoresis device.

Dated: March 13, 1995.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 95–6854 Filed 3–20–95; 8:45 am]

BILLING CODE 4140–01–P

National Heart, Lung, and Blood

Institute; Meeting

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

following Heart, Lung, and Blood

Special Emphasis Panel.

The meeting will be open to the

public to provide concept review of

proposed contract or grant solicitations.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

inform the Contact Person listed below

in advance of the meeting.

Name of Panel: NHLBI SEP on Blood

Diseases.

Dates of Meeting: April 27–28, 1995.

Time of Meeting: 9 a.m.

Place of Meeting: National Institutes of

Health, Natcher Building, Building 45, Lower

Level Room D, Bethesda, Maryland.

Agenda: The panel will review the current

status of research in the designated areas,

identify gaps and make recommendations

regarding opportunities and priorities for

future contract or grant solicitations.

Contact Person: Dr. Fann Harding, 7550

Wisconsin Avenue, Room 5A08, Bethesda,

Maryland 20892, (301) 496–1817.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: March 14, 1995.

Margery G. Grubb,

Senior Committee Management Specialist,

National Institutes of Health.

[FR Doc. 95–6851 Filed 3–20–95; 8:45 am]

BILLING CODE 4140–01–M

National Heart, Lung, and Blood

Institute; Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Heart,

Lung, and Blood Special Emphasis

Panel (SEP) meetings:

Name of SEP: Response and Adaptation to

Exercise-Unit II (Telephone Conference Call).

Date: April 6, 1995.

Time: 1 p.m.

Place: 5333 Westbard Avenue, Room 552,

Bethesda, Maryland.

Contact Person: S. Charles Selden, Ph.D.,

5333 Westbard Avenue, Room 552, Bethesda,

Maryland 20892, (301) 594–7476.

Purpose/Agenda: To review and evaluate

grant applications.

Name of SEP: The Insulin in Resistance

Atherosclerosis Study (IRAS).

Date: April 18, 1995.

Time: 12:30 p.m.

Place: Crystal Gateway Marriott, Arlington,

Virginia.

Contact Person: David Monsees, Jr., Ph.D.,

5333 Westbard Avenue, Room 550, Bethesda,

Maryland 20892, (301) 594–7450.

Purpose/Agenda: To review and evaluate

grant applications.

These meetings will be closed in

accordance with the provisions set forth

in sec. 552b(c)(4) and 552b(c)(6), Title 5,

U.S.C. Applications and/or proposals

and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material

and personal information concerning

individuals associated with the

applications and/or proposals, the

disclosure of which would constitute a

clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: March 14, 1995.

Margery G. Grubb,

Senior Committee Management Specialist,

National Institutes of Health.

[FR Doc. 95–6850 Filed 3–20–95; 8:45 am]

BILLING CODE 4140–01–M