[Federal Register Volume 66, Number 50 (Wednesday, March 14, 2001)]
[Notices]
[Pages 14908-14909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Institutes of Health, 
National Institute on Child Health and Human Development; 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 diagnostic and therapeutic uses 
of the newly identified human MATER (Maternal Effect Gene) gene and 
protein that are critical for normal oocyte function and fertility. 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 13, 2001. Formal 
proposals must be submitted to this office no later than May 14, 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: Lawrence 
[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 patent 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 maintaining oocyte quality so as to support healthy early 
embryonic development. The project goal is to determine if 
abnormalities in the amount or quality of oocyte MATER content play a 
role in some cases of human infertility that is generally ascribed to 
``poor egg quality'' or a failure of early embryonic development. A 
strategy should be developed to measure MATER's biologic activity, to 
determine the MATER content of human oocytes, and to detect MATER gene 
mutations. Preimplantation mouse oocytes and embryos may be used for 
protein analysis and profiling. Basic science expertise as applied to 
oocyte function in animal models and in the clinical setting will be 
required.
    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;

[[Page 14909]]

    (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:
    (1) Expertise:
    A. Scientific advisors and staff with a demonstrated record of 
research success related to diagnostic and therapeutic interventions 
associated with human fertility.
    (i) The 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. 01-6274 Filed 3-13-01; 8:45 am]
BILLING CODE 4140-01-P