[Federal Register Volume 69, Number 6 (Friday, January 9, 2004)]
[Notices]
[Pages 1590-1591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-451]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute (NHLBI): Opportunity 
for Cooperative Research and Development Agreements (CRADAs) to Develop 
Novel Mechanical and Biological Treatments in Interventional 
Cardiovascular Medicine Using X-ray Fluoroscopy and/or Real-Time 
Magnetic Resonance Imaging

ACTION: Notice.

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SUMMARY: The National Heart, Lung and Blood Institute (NHLBI) of the 
National Institutes of Health (NIH) announces the opportunity for 
Cooperative Research and Development Agreements (CRADAs) to develop 
novel mechanical and biological treatments in

[[Page 1591]]

interventional cardiovascular medicine using x-ray fluoroscopy and 
real-time magnetic resonance imaging. The NHLBI seeks potential 
collaborators wishing to provide expertise in (1) novel biological 
treatments for cardiovascular disease, including agents to facilitate 
mobilization of bone-marrow-derived stem and progenitor cells, (2) 
novel agents for therapeutic angiogenesis for myocardial or peripheral 
artery applications, (3) novel immune-modulating agents to treat or 
prevent manifestations of atherosclerosis, coronary artery occlusion, 
or myocardial ischemia/infarction, (4) novel mechanisms of drug, gene, 
or cell delivery to the myocardium or skeletal muscle to treat 
manifestations of coronary or peripheral artery atherosclerosis, and 
(5) intravascular devices for real-time magnetic resonance imaging-
guided treatments including but not limited to angioplasty balloons, 
recanalization systems, percutaneous cardiac valves, stents, 
endografts, and bypass grafts.
    The NHLBI seeks capability statements from parties interested in 
entering into a potential CRADA to manufacture, prototype, and test the 
above-specified agents or devices leading to early clinical testing and 
development. The availability of private sector support may increase 
the feasibility of particular aspects of the final design, but the 
primary criterion for selecting potential collaborators is the 
scientific merit of proposals for developing a plan to identify novel 
putative therapeutic agents and devices.
    The NHLBI can provide extensive preclinical and clinical support in 
the development of collaborator deliverables, including animal 
experiments, advanced x-ray fluorscopic and magnetic resonance imaging 
laboratories, and investigations conducted in the Warren G. Magnuson 
Clinical Center at the Bethesda campus of the National Institutes of 
Health.
    The control of clinical trials shall reside entirely with the 
Institute and the scientific participants of the trial. In the event 
that any adverse effects are encountered which, for legal or ethical 
reasons, may require communication with the U.S. Food and Drug 
Administration, the relevant collaborating institutions will be 
notified. Neither the conduct of the trial nor the results should be 
represented as an NHLBI endorsement of the agent, drug, or device under 
study.

DATES: Only written CRADA capability statements received by the NHLBI 
within 21 days of publication of this notice will be considered during 
the initial design phase. Confidential information must be clearly 
labeled. Potential collaborators may be invited to meet with the 
Selection Committee at the Collaborators' expense to provide additional 
information. The Institute may issue an additional notice of CRADA 
opportunity during the design phase if circumstances change or if the 
design alters substantially.

FOR FURTHER INFORMATION CONTACT: Capability statements should be 
submitted to Ms. Peg Koelble, Office of Technology Transfer and 
Development, National Heart, Lung, and Blood Institute, National 
Institutes of Health, 6705 Rockledge Drive, Suite 6018, Bethesda, MD 
20892-7992; Tel: 301-594-4095; Fax: 301-594-3080; e-mail: 
[email protected].
    Capability Statements: A selection committee will use the 
information provided in the ``Collaborator Capability Statements'' 
received in response to this announcement to help in its deliberations. 
It is the intention of the NHLBI that all qualified collaborators have 
the opportunity to provide information to the selection committee 
through their capability statements. The capability statement should 
not exceed 10 pages and should address the following selection 
criteria:
    1. The statement should provide specific details of the method to 
be used in the development of novel candidate biological treatments, 
delivery systems, or real-time MRI-guided mechanical treatments for 
cardiovascular disease.
    2. The statement should include a detailed plan demonstrating the 
ability to provide sufficient capacity in drug, gene, or stem cell 
development and manufacturing or in mechanical device prototyping, 
testing, development, and manufacturing.
    3. The statement may include outline measures of interest to the 
collaborator. The specifics of the proposed outcome measures and the 
proposed support should include but not be limited to: expertise in the 
proposed field, specific personnel allocation to the proposed 
collaboration, specific internal or external funding commitment to 
support the advancement of scientific research, services, facilities, 
equipment, or other resources that would contribute to the conduct of 
the commercial development.
    4. The statement must address willingness promptly to publish 
research results and ability to be bound by PHS intellectual property 
policies (See CRADA: http://ott.od.nih.gov/newspages/crada.pdf).

    Dated: January 2, 2004.
Carl Roth,
Associate Director for Scientific Program Operation, National Heart, 
Lung, and Blood Institute.
[FR Doc. 04-451 Filed 1-8-04; 8:45 am]
BILLING CODE 4140-01-M