This PA is a reissue of RFA MH-02-003.
The National Institute of Mental Health (NIMH), the National Institute on Aging
(NIA), National Institute of Alcohol Abuse and Alcoholism (NIAAA),
National Institute of Biomedical Imaging and Bioengineering (NIBIB), the
National Institute on Drug Abuse (NIDA), and National Institute of Neurological
Disorders and Stroke (NINDS) request research grant applications for the
development of novel radioligands for positron emission tomography (PET) and
single photon emission computed tomography (SPECT) imaging in human brain, and
that incorporate pilot or clinical feasibility evaluation in pre-clinical
studies, model development, or clinical studies.
This initiative is intended to facilitate the development of: 1) PET and SPECT
probes for molecular targets (e.g., receptors, intracellular messengers,
disease-related proteins) that are of broad interest to the neuroscience
research community, and 2) new technologies for radiotracer development.
The primary motivation for this initiative is the lack of versatile agonist and
antagonist PET and SPECT radiotracers for molecular targets that are implicated
in brain disorders. The use of radiotracers for imaging molecular events in
preclinical and clinical studies is essential for understanding the circuitry
that underlies normal brain function and the pathophysiology of brain disorders.
It is the intent of this initiative to foster the development of NIH
partnerships with scientists from pharmaceutical industry and academic nuclear
medicine research centers to develop ligands for PET and SPECT brain imaging
with the goal of making new radioligands accessible to the research community
as essential research tools for central nervous system (CNS) imaging, and as
potential biological markers and surrogate endpoints for translational and
clinical research, drug discovery and development, and clinical trials.
This solicitation will utilize the Phased Innovation Award Mechanism that is
intended to encourage the development and application of technology in
neurobiological research. Specific features of this mechanism include:
o Single submission and evaluation of both the R21 and R33 phases as one
application. An R33 application alone may be submitted.
o Expedited transition from the feasibility phase (R21) to the development
phase (R33) based on successful completion of negotiated quantitative
Milestones.
o Flexible staging of feasibility (R21) and development (R33) phases.
o Applications from industry or industry partnerships with other groups are
encouraged.
o Review of submissions by the Center for Scientific Review (CSR) and
expedited NIH programmatic review for transition from the R21 to the R33 phase.
Small businesses are encouraged to respond to the parallel PA, PA-02-028,
Development of PET and SPECT Ligands for Brain Imaging (SBIR Award)
http://grants.nih.gov/grants/guide/pa-files/PA-02-028.html. Its objectives are
identical; however, it will use the Small Business Innovation Research (SBIR)
and Small Business Technology Transfer (STTR) mechanisms. The same expedited
review and transition from Phase I to Phase II funding are expected to apply,
as will the same cost and time limitations as this PA for Phased Innovation
Awards.