[Federal Register Volume 66, Number 48 (Monday, March 12, 2001)]
[Notices]
[Pages 14397-14398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Child Health and Human Development (NICHD); 
Opportunity for Cooperative Research and Development Agreement

SUMMARY: The National Institute of Child Health and Human Development 
(NICHD) is seeking research statements from parties interested in 
entering into a Cooperative Research and Development Agreement (CRADA). 
The purpose of the CRADA is to develop new strategies for the 
identification of MATER (Maternal Effect Gene) specific to the 
remodeling of chromosomal architecture, and the transcription and 
translation that support healthy mammalian oocytes and early embryonic 
development. The project is part of the ongoing activities of the 
Developmental Endocrinology Branch (DEB), Division of Intramural 
Research, NICHD. The term of the CRADA will be up to five (5) years.

DATES: Interested parties should notify this office in writing of their 
intent to file a formal proposal no later than April 11, 2001. Formal 
proposals must be submitted to this office no later than May 11, 2001.

ADDRESSES: Research Statements should be submitted to Kate Sinclair 
Dunn, Technology Development Specialist, Technology Development and 
Commercialization Branch, National Cancer Institute, National 
Institutes of Health, Executive Plaza South, Room 450, 6120 Executive 
Blvd., MSC 7182, Bethesda, MD 20892-7182, Phone: 301-496-0477, Fax: 
301-402-2117, e-mail [email protected]. Scientific questions 
should be addressed to Lawrence M. Nelson, M.D., Head, Gynecological 
Endocrinology Unit Developmental Endocrinology Branch, NICHD, NIH, 
Building 10, Room 10N262, Bethesda, MD 20892-1862; Phone (direct): 301-
402-6608, Office: 301-496-4686; Fax: 301-402-0574, e-mail: 
[email protected]. Inquiries directed to obtaining patent 
license(s) related to participation in the CRADA opportunity should be 
addressed to Dennis Penn, Pharm.D., MPH, Senior Technology Licensing 
Specialist, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Blvd., Suite 325, Rockville, MD 20852-3804, 
Phone: 301-496-7735, Fax: 301-402-0220, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: A CRADA is the anticipated joint agreement 
to be entered into by NICHD and a collaborator pursuant to the Federal 
Technology Transfer Act of 1986 (15 U.S.C. 3710 a), as amended. A CRADA 
is an agreement designed to enable certain collaborations between 
Government laboratories and non-Government laboratories. It is not a 
grant, and is not a contract for the procurement of goods/services. The 
NICHD is prohibited from transferring funds to a CRADA Collaborator. 
Under a CRADA, the NICHD can offer the selected collaborator access to 
facilities, staff, materials, and expertise. The collaborator may 
contribute facilities, staff, materials, expertise, and funding to the 
collaboration. A CRADA collaborator may elect an option to an exclusive 
or non-exclusive license to Government intellectual property rights 
arising under the CRADA, and may qualify as a co-inventor of new 
technology developed under the CRADA. As between two or more 
sufficient, overlapping research proposals (where the overlap cannot be 
cured), the NICHD, as specified in 15 U.S.C. 3710a(c)(4), will give 
special consideration to small businesses, and will give preference to 
business units located in the U.S. that agree to manufacture CRADA 
products in the U.S.
    The CRADA will employ a MATER null mouse line to examine the role 
of MATER in effecting the embryonic program switch from the maternal 
genome to the zygotic genome. The project's goal is to define MATER's 
role in embryonic transcription, transition from control by the 
maternal to the zygotic genome, signal transduction, cell cycle 
control, and to identify proteins that interact with MATER. A strategy 
should be developed to extract RNA from oocytes and early stage mouse 
embryos to create cDNA libraries to identify the genes that are 
critical to oocyte function and early embryonic development. 
Furthermore, a strategy will be implemented for development of a chip 
technology for oocyte and embryonic gene activation. Preimplantation 
mouse embryos may also be used for protein analysis and profiling. 
Specific gene loci or gene sequences that are identified will be 
analyzed and may be employed in the molecular manipulation of animal 
oocytes or early embryos.
    The described methods are the subject of a U.S. provisional patent 
application filed October 18, 2000 by the Public Health Service on 
behalf of the Federal Government. Furthermore, the initial report and 
characterization of the invention is described in: Tong et al., Mamm. 
Genome 11:281-287, 2000. Commercialization of new CRADA technology may 
require obtaining an appropriate PHS license.
    The collaborator in this endeavor is expected to commit scientific 
personnel commensurate with the level of research activities defined by 
the CRADA Research Plan. It is anticipated that PHS laboratories and/or 
those of the collaborator will be utilized, as appropriate, for the 
research activities as defined by the Research Plan. NICHD anticipates, 
in addition, that the Collaborator, as appropriate, will provide 
funding for the project.

Party Contributions

    The NICHD anticipates that its role may include, but not be limited 
to, the following:
    (1) Plan research studies, interpret research results, and, as 
appropriate, jointly publish the conclusions with the collaborator;
    (2) Provide collaborator with access to existing NICHD research 
data (both already collected and yet to be collected);
    (3) Provide staff, expertise, and materials for the development and 
testing of promising products;
    (4) Provide work space and equipment for testing of any prototype 
compositions developed.
    The NICHD anticipates that the role of the successful collaborator 
will include the following:
    (1) Provide significant intellectual, scientific, and technical 
expertise in the development and manufacture of relevant products;
    (2) Plan research studies, interpret research results, and, as 
appropriate, jointly publish the conclusions; and
    (3) Provide NICHD a supply of necessary materials, access to 
necessary proprietary technology and/or data, and as necessary for the 
project, staff and funding in support of the research goals.
    Other contributions may be necessary for particular proposals.

Selection Criteria

    Proposals submitted for consideration should address, as best as 
possible and to the extent relevant to the proposal, each of the 
following:

[[Page 14398]]

(1) Expertise

    A. Scientific advisors and staff with a demonstrated record of 
research success related to remodeling of chromosomal architecture, 
transcription, and translation, and
    (i) Technical expertise of the Collaborator's Principal 
Investigator and laboratory group in the technology described above,

(2) Reliability as a Research Partner

    A. Willingness to commit best effort and to provide adequate and 
sustained resources and/or funding, as appropriate, to support the 
CRADA studies, and
    B. Development of this technology, as outlined in the CRADA 
Collaborator's proposal, and
    C. Ability to develop and produce products in a timely manner, as 
applicable (for example, as demonstrated by a history of meeting 
benchmarks in licenses), and
    D. Commitment to supporting the advancement of scientific research, 
as evidenced by a willingness to jointly publish research results in a 
prompt manner, and
    E. Willingness to be bound by DHHS and PHS policies regarding:
    (i) the public distribution of unmodified genetic sequences and 
research tools,
    (ii) the care and handling of animals, and
    (iii) testing in human subjects.

(3) Physical Resources

    A. An established headquarters, with office space and basic office 
equipment, and
    B. Access to the organization during business hours by telephone, 
facsimile, courier, U.S. Post, e-mail, the World-Wide-Web, and, as 
appropriate, other evolving information technologies, and
    C. Sufficient financial and material resources to support, at a 
minimum, the anticipated activities of the CRADA to meet the needs of 
NICHD under the proposal.
    The collaborator is encouraged to propose, in the written research 
statement, related applications and technologies other than those 
specifically described herein.

    Dated: February 26, 2001.
Kathleen Sybert,
Chief, TDCB/NCI/NIH.
[FR Doc. 01-6038 Filed 3-9-01; 8:45 am]
BILLING CODE 4140-01-P