14954 Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Notices

• Analyzes the policy implications of

findings on health, information,

outcomes, access, coverage and quality.

E.(2) Division of Aging and Disability

(FKB62)

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

program eligibility for populations that

include persons with mental and

physical chronic disease and

disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

coverage for populations that include

persons with mental and physical

chronic disease and disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

cost of care for populations that include

persons with mental and physical

chronic disease and disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

access to care for populations that

include persons with mental and

physical chronic disease and

disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations on issues that affect

quality of health and long-term care

services for populations that include

persons with mental and physical

chronic disease and disabilities.

• Conducts intramural and

extramural research, demonstrations

and evaluations related to new measures

of quality of care for populations that

include persons with mental and

physical chronic disease and

disabilities.

• Analyzes trends in long-term care

programs and market characteristics.

• Analyzes the policy implications of

findings on issues that affect aging and

disability.

F. Office of Research and

Demonstrations Support (FKB7)

• Directs the Fiscal Intermediary and

Carrier activities for demonstrations.

• Directs the development,

implementation and ongoing operations

of demonstrations.

• Directs the design and development

of payment methodologies for

demonstrations, special cost reports and

operational manuals.

• Directs the design, development

and implementation of mainframe and

personal computer (PC) based claims

processing systems and collation of

evaluation data.

• Directs the development of data

programs to monitor and evaluate trends

in Medicare/Medicaid and the health

care system.

• Oversees programming and dataset

technical assistance.

• Directs the control and support for

PC’s, local area networks (LAN’s),

computer communications and

mainframe computer hardware/software

packages.

• Participates with the Bureau of Data

Management and Strategy (BDMS) in

providing support and access to HCFA’s

data bases as required by research and

demonstration activities.

F.(1) Division of Demonstrations

Support (FKB71)

• Serves as Fiscal Intermediary and

Carrier for demonstrations.

• Participates in the development,

implementation and ongoing operations

of demonstrations.

• Designs and develops payment

methodologies when needed for

demonstrations and studies, such as

special cost reports, special operational

manuals and participates in facilitating

demonstrations.

• Designs, develops and implements

mainframe and PC claims processing

systems and collates data for

evaluations.

• Conducts on-site audits of

submitted costs reports and validates

services rendered.

F.(2) Division of Data Systems

Resources (FKB72)

• Develops, manages and maintains a

variety of data programs to monitor and

evaluate trends in Medicare/Medicaid

and the health care system.

• Provides and participates in a

variety of data support activities related

to quality control and data verification.

• Provides programming and dataset

technical assistance.

• Provides control and support for

PCs, LAN, computer communications

and mainframe computer hardware/

software packages.

• Participates with BDMS in

providing necessary support and access

to HCFA’s data bases as required by

research and demonstration activities.

• Coordinates ORD’s participation in

computer-based systems.

• Designs and develops a variety of

analytic data bases.

Dated: March 8, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 95–6885 Filed 3–20–95; 8:45 am]

BILLING CODE 4120–01–P

National Institutes of Health

National Cancer Institute; Opportunity

for a Cooperative Research Agreement

(CRADA) for the Scientific and

Commercial Development of

Diagnostic and/or Therapeutic Agents

for Hyperpigmentary Lesions

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The National Cancer Institute

(NCI), seeks a pharmaceutical or

cosmetic company that can effectively

pursue the scientific and commercial

generation and development of agents

inhibiting pigmentation. The project is

of scientific importance since it will

characterize mechanisms whereby

melanocyte function is compromised to

produce hyperpigmented lesions. As

such, this research will seek to provide

insights into mechanisms responsible

for clinically abnormal

hyperpigmentation such as occurs in

postinflammatory hyperpigmentation

and other pigmentary diseases. NCI has

successfully characterized the

melanogenetic functions of several

pigmentary genes that are important to

the regulation of mammalian

pigmentation. The NCI has produced a

number of specific antibodies which

recognize those gene products as well as

a number of oligonucleotides and

cDNAs whereby expression of their

encoding genes can be quantitated. The

selected sponsor will collaborate in a

project aimed at using those probes to

characterize melanocyte function in

hyperpigmentary conditions and to

develop agents useful commercially to

down regulate melanogenic function.

ADDRESSES: Inquiries and proposals

regarding this opportunity should be

addressed to Mark Noel or Bert Zbar

(Telephone (301) 496–0477, Facsimile

(301) 402–2117), Office of Technology

Development, National Cancer Institute,

Bldg 31, Room 4A49, National Institutes

of Health, 9000 Rockville Pike,

Bethesda, MD 20892

DATES: Proposals must be received at the

above address by no later than May 22,

1995.

SUPPLEMENTARY INFORMATION:

‘‘Cooperative Research and

Development Agreement’’ or ‘‘CRADA’’

means the anticipated joint agreement to

be entered into by NCI pursuant to the

Federal Technology Transfer Act of

1986 and Executive Order 12591 of

October 10, 1987 to collaborate on the

specific research project described

below.

The NCI is seeking a pharmaceutical

or cosmetic company which can lend
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