[Federal Register Volume 64, Number 67 (Thursday, April 8, 1999)]
[Notices]
[Pages 17188-17189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Aging; Cooperative Research and Development 
Agreement (CRADA) Opportunity to Develop a Library of New cDNA Clones 
Derived From Mouse Stem Cells

AGENCY: NIA, NIH, DHHS.

ACTION: Notice.

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SUMMARY: The Laboratory of Genetics, in the National Institute on Aging 
(NIA), is seeking at least one collaborator to participate in a 
Cooperative Research and Development Agreement (CRADA) to develop uses 
for a growing library of new cDNA clones. The Laboratory of Genetics 
has been collecting the cDNA clones from mouse embryonic tissues. A 
current first cohort of 15,000 unique genes, with an average length of 
1.5 kb, includes more than 40% that are previously unknown by 
comparison with all entries in dbEST (2/1/99); subsequent additional 
cohorts, aiming at more uniformly full-length clones and including 
comparable fractions of additional previously unknown genes, are in 
development. The NIA is interested in developing this unique cDNA 
library into a variety of prognostic, diagnostic, and therapeutic 
applications.
    This opportunity is not necessarily limited to a single 
collaborator or a single CRADA; all viable proposals that are 
consistent with the mission of the NIA and the goals of the Laboratory 
of Genetics will be considered. If more than one acceptable CRADA 
proposal is received, NIA may require that each research plan be 
crafted to protect against overlap. The term of each CRADA will be up 
to five (5) years.

DATES: Interested parties should notify the National Cancer Institute's 
Technology Development & Commercialization Branch, in writing, of their 
intent to file a formal proposal no later than May 24, 1999. Formal 
proposals must be submitted to this office no later than June 7, 1999.

ADDRESSES: Inquiries and proposals regarding this opportunity should be 
addressed to Bruce D. Goldstein; NCI Technology Development & 
Commercialization Branch; Suite 450, 6120 Executive Blvd.; Rockville, 
Maryland, 20852 (Tel. # 301-496-0477, FAX # 301-402-2117). Scientific 
inquiries should be addressed to Dr. David Schlessinger, Chief; NIA 
Laboratory of Genetics, 5600 Nathan Shock Drive; Baltimore, Maryland, 
21224 (Tel. # 410-558-8337, FAX # 410-558-8331). Copies of the PHS 
Model CRADA are available.

SUPPLEMENTARY INFORMATION: A CRADA is the anticipated joint agreement 
to be entered pursuant to the Federal Technology Transfer Act of 1986, 
as amended by the National Technology Transfer and Advancement Act 
(Pub. L. 104-113 (Mar. 7, 1995)) and by Executive Order 12591 of April 
10, 1987.
    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 NIA IS PROHIBITED FROM TRANSFERRING FUNDS TO A CRADA 
COLLABORATOR. Under a CRADA, the NIA can offer the selected 
collaborator(s) access to facilities, staff, materials, and expertise. 
The collaborator(s) 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

[[Page 17189]]

arising under the CRADA, and may qualify as a co-inventor of new 
technology developed under the CRADA. Any party is eligible to 
participate; however, as between two or more sufficient, overlapping 
research proposals (where the overlap cannot be cured), the NIA, 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 NIA's principal objectives for this CRADA opportunity are the 
rapid publication of research findings, and the timely 
commercialization of prognostic, diagnostic, or therapeutic products. 
In particular, under the present proposal, the specific goals of the 
CRADA may include, but are not necessarily be limited to, the 
development of the following technology:
     Development of one or more diagnostic assays using gene 
arrays;
     Creation of pharmaceutical compositions derived from 
specific cDNA sequences; and
     Development of improved informatics concerning the 
analysis of expression of cDNA sequences identified by NIA.
    Collaborators are encouraged to recommend additional applications 
and technologies to be developed in their written proposals.

Policy Considerations

    The rapid advancement of many important avenues of biomedical 
research depend on the ready access to high quality clones and 
sequences of mammalian cDNA. The NIA acknowledges that, to provide 
commercial parties an incentive to develop a technology into a product, 
patent applications sometimes must directly claim a genetic sequence or 
clone so that a related diagnostic, prognostic, or therapeutic 
invention will be adequately protected. At the same time, the NIA is 
concerned that patent applications claiming clones and their associated 
sequences ``per se''--in other words, in the absence of a demonstrated 
diagnostic, prognostic, or therapeutic function--could have a chilling 
effect on other research into products that will benefit the public 
health. Consequently, the NIA is committed, wherever possible, to 
making such per se cDNA libraries, clones, and sequences publicly 
available, without restriction, in a timely manner (for example, by 
placing them in public databases and repositories). All successful 
collaborators will acknowledge NIA's policy and will take meaningful 
steps to accommodate it wherever possible.

Party Contributions

    The role of NIA may include the following:
    (1) Plan research studies, interpret research results, and, with 
the collaborator, jointly publish the conclusions;
    (2) Provide collaborator with access to mouse-embryonic cDNA 
clones, sequence information, and other research data (both already 
collected and yet to be collected);
    (3) Provide staff, expertise, & materials for the development and 
testing of promising products; and
    (4) Provide work space and equipment for testing of any prototype 
compositions developed.
    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, with 
NIA, jointly publish the conclusions;
    (3) Provide to NIA a supply of materials, access to necessary 
proprietary technology and/or data, and as necessary for the project, 
staff and funding in support of the research goals; and
    (4) Provide resources to develop and market any promising products.
    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 qualifications:
    (1) Expertise:
    A. Expertise in developing and producing high quality 
pharmaceutical compositions;
    B. Demonstrated ability to secure national marketing and 
distribution of its products (international distribution a plus);
    C. Demonstrated expertise in informatics, and in handling of arrays 
of clones and genes; and
    D. Demonstrated intellectual ability in the prediction and 
verification of diagnostic, prognostic, and/or therapeutic products 
based on sequences and genetic properties.
    (2) Reliability as a research partner:
    A. Produces quality products in a timely manner (for example, as 
demonstrated by a history of meeting benchmarks in licenses);
    B. Indications of high levels of satisfaction by industry with the 
collaborator's products; and
    C. Commitment to supporting the advancement of scientific research, 
as evidenced by a willingness to publish research results in a prompt 
manner, and a willingness to be bound by DHHS and PHS policies 
regarding:
    (i) the public distribution of unmodified genetic sequences and 
pure research tools,
    (ii) the care and handling of animals, and
    (iii) testing in human subjects.
    Proposals MUST address the collaborator's policy on the handling of 
intellectual property rights in, and the public dissemination of, cDNA 
sequences, clones, and libraries to be developed under a prospective 
CRADA.
    (3) Physical Resources:
    A. An established headquarters, with office space and equipment;
    B. Access to the organization during business hours by telephone, 
facsimile, courier, U.S. Post, e-mail, the World-Wide-Web, and other 
evolving technologies; and
    C. Sufficient financial and material resources to support, at a 
minimum, the anticipated activities of the CRADA to meet the needs of 
NIA under the proposal.

    Dated: March 19, 1999.
Kathleen Sybert,
Director, Technology Development & Commercialization Branch, National 
Cancer Institute, National Institutes of Health.
[FR Doc. 99-8672 Filed 4-7-99; 8:45 am]
BILLING CODE 4140-01-P