[Federal Register Volume 60, Number 54 (Tuesday, March 21, 1995)]
[Notices]
[Pages 14954-14955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6855]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.

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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 [[Page 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, royalty-free 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