[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Notices]
[Pages 3715-3716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute (NHLBI); Opportunity 
for a Cooperative Research and Development Agreement (CRADA) to 
Identify and Explore Epigenetic Regulatory Elements for Diagnostic and 
Therapeutics Purposes

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The National Heart, Lung, and Blood Institute (NHLBI) is 
seeking Cooperative Research and Development Agreement (CRADA) 
collaborator(s) to work with investigators in the Laboratory of 
Molecular Immunology (LMI) to identify epigenetic regulatory elements 
that may be involved in the disease development of T and/or B cell 
leukemia/lymphoma and other cancers via genome-wide analysis of 
acetylation islands using the Genome-Wide Mapping Technique (GMAT). 
Representative disease-specific acetylation islands will be explored 
for diagnostic and therapeutic purposes.

SUPPLEMENTARY INFORMATION: Epigenetics play a critical role in cellular 
development and cellular transformation in many pathogenic processes. 
For example, many cancers are correlated with changes of their 
chromatin structure and are sensitive to drugs that modulate the levels 
of histone acetylation. Epigenetic regulation refers to the 
modification of chromatin including posttranslational modification of 
histones, which does not involve change of DNA sequences of target 
genes. MHLBI investigators have mapped the genome-wide distribution of 
histone H3 acetylation in human T cells and discovered over 40,000 
acetylation islands using a technique called GMAT. This tool combines 
Chromatin immunoprecipitation (Chip) of hyper-acetylated histones, with 
Serial Analysis of Gene Expression (SAGE). The acetylation islands are 
epigenetic markers for transcriptional regulatory elements and 
chromatin controlling elements. Changes of the acetylation islands may 
be correlated with early development of T cell lymphoma or leukemia. 
Therefore, this discovery may be applied to early diagnosis and/or 
treatment of these diseases.
    The NHLBI is seeking capability statements from parties interested 
in entering into a CRADA to identify, explore and further develop 
epigenetic regulatory elements/acetylation islands for diagnostic and 
therapeutic purposes. The role of the CRADA collaborator(s) will 
include, but not be limited to, the following:
    1. The ability to collaborate with NHLBI on further research and 
development of this technology. This ability can be demonstrated 
through experience and expertise in this or related areas of technology 
indicating the ability to contribute intellectually to on-going 
research and development.
    2. To assist with obtaining specimen/tissues (patient and normal 
controls) for the Genome-Wide analysis as diagnostic and therapeutic 
markers.
    3. To assist to further developing the epigenetic regulatory 
elements markers/acetylation islands as new targets for novel drug-
development strategies.
    The collaborator may also be expected to contribute financial 
support under this CRADA for personnel, supplies, travel, and equipment 
to support these projects. The collaborator is also expected to 
cooperate with the NHLBI in the timely publication of research results 
and to accept the legal provisions and language of the CRADA with only 
minor modifcations, if any.

DATES: CRADA capability statements should be submitted to Vincent 
Kolesnitchenko, Ph.D., Technology Transfer Specialist, National Heart, 
Lung, and Blood Institute (NHLBI), Office of Technology Transfer and 
Development, National Institutes of Health, 6705 Rockledge Drive, Suite 
6018, MSC 7992, Bethesda, MD 20892-7992; Phone: (301) 594-4115; Fax: 
(301) 594-3080; E-mail: [email protected]. Capability statements must be 
received on or before March 28, 2005.
    The NHLBI has applied for patents claiming the core of the 
technology. Non-exclusive and/or exclusive licenses for these patents 
covering core aspects of this project are available to interested 
parties.
    Licensing inquiries regarding this technology should be addressed 
to John Stansberry, Ph.D., Technology Licensing Specialist, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, Maryland 20852-3804, Phone: (301) 435-
5236; Fax: (301) 402-0220; E-mail: [email protected]. Information 
about Patent Applications and pertinent information not yet publicly 
described an be obtained under the terms of a Confidential Disclosure 
Agreement.
    Respondents interested in submitting a CRADA Proposal should be 
aware that it may be necessary to secure a license to the above-
mentioned patent rights in order to commercialize products arising from 
a CRADA.


[[Page 3716]]


    Dated: January 14, 2005.
Dr. Carl Roth,
Associate Director for Scientific Program Operations, National Heart, 
Lung, and Blood Institute.
[FR Doc. 05-1412 Filed 1-25-05; 8:45 am]
BILLING CODE 4140-01-M