[Federal Register: December 5, 2003 (Volume 68, Number 234)]
[Notices]
[Page 68088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de03-72]
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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 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 to 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 fluoroscopic 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 Additonal Information and Questions: 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; email: koelblep@nhlbi.nih.gov.
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 commerical 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/newpages/crada.pdf).
Dated: November 26, 2003.
Carl Roth,
Associate Director for Scientific Program Operation, National Heart,
Lung, and Blood Institute.
[FR Doc. 03-30206 Filed 12-4-03; 8:45 am]
BILLING CODE 4140-01-M