[Federal Register Volume 67, Number 44 (Wednesday, March 6, 2002)]
[Notices]
[Pages 10178-10180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5305]
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DEPARTMENT OF ENERGY
Office of Science Financial Assistance Program Notice 02-21;
Medical Applications Program
AGENCY: U.S. Department of Energy (DOE).
ACTION: Notice inviting grant applications.
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SUMMARY: The Office of Biological and Environmental Research (OBER) of
the Office of Science (SC), U.S. Department of Energy (DOE), hereby
announces its interest in receiving grant applications to support
radiopharmaceutical research for Noninvasive Radiotracer-cell Imaging
(NRI) In Vivo. The specific goals include radiotracer labeling of
progenitor cells for noninvasively imaging and tracking their behavior
and fate in vivo and their overall role in organ and tissue
regeneration in disease states. The applicants should clearly
demonstrate the relevance and important clinical need of the research
proposed. Special consideration will be given to applications arising
from a well integrated, multidisciplinary team effort of scientists
with relevant skills in radiopharmaceutical chemistry, biology,
pharmacology and clinical nuclear medicine. The access to, or
availability of specialized radiotracer-labeling and imaging
instrumentation, equipment and facilities for real time imaging in
animals to humans, will be important factors for funding
considerations.
DATES: Potential applicants are encouraged to submit a brief
preapplication before preparing a formal application. All
preapplications in response to Program Notice 02-21 should be received
by DOE by 4:30 p.m., E.D.T., April 1, 2002. A response encouraging or
discouraging the submission of a formal application will be
communicated via email by April 15, 2002.
Formal applications submitted in response to this notice must be
received by 4:30 p.m., E.D.T., May 15, 2002, to be accepted for merit
review and consideration for award in Fiscal Year 2002.
ADDRESSES: Preapplications referencing Program Notice 02-21 must be
sent via electronic mail to: [email protected] or by fax to
(301) 903-0567.
Formal applications referencing Program Notice 02-21, should be
forwarded to: U.S. Department of Energy, Office of Science, Grants and
Contracts Division, SC-64, 19901 Germantown Road, Germantown, MD 20874-
1290, ATTN: Program Notice 02-21. This address must also be used when
submitting applications by U.S. Postal Service Express Mail or any
other commercial overnight delivery service, or hand-carried by the
applicant. An original and seven copies of the application must be
submitted.
FOR FURTHER INFORMATION CONTACT: Dr. Prem C. Srivastava, Office of
Biological and Environmental Research, Medical Sciences Division (SC-
73), U.S. Department of Energy, 19901 Germantown Road, Germantown, MD
20874-1290, telephone: (301) 903-4071, fax: (301) 903-0567, e-mail:
[email protected]. The full text of Program Notice 02-21
is available via the Internet using the following web site address:
http://www.science.doe.gov/production/grants/grants.html.
SUPPLEMENTARY INFORMATION:
Progenitor Cells
The term progenitor cells implies non-embryonic stem cells, and
does not include embryonic stem cells. For definitions, refer to
National Institutes of Health (NIH) web sites, and all grantees must
adhere to federal guidelines when involving human subjects. http://www.nih.gov/news/stemcell/primer.htm; http://www.nih.gov/news/stemcell/index.htm.
[[Page 10179]]
Biological and Environmental Research (BER), Medical Applications
Program
For more than 50 years the Biological and Environmental Research
(BER) program has been advancing environmental and biomedical knowledge
that promotes national security through improved energy production,
development, and use, international scientific leadership that
underpins our nation's technological advances, and environmental
research that improves the quality of life for all Americans. BER
supports these vital national missions through competitive and peer-
reviewed research at National Laboratories, universities, and private
institutions.
The mission of the BER Medical Applications subprogram is to
deliver relevant scientific knowledge that will lead to innovative
diagnostic and treatment technologies for human health. The research
builds on unique DOE capabilities in physics, chemistry, engineering,
and biology. Research will lead to new metabolic labels and imaging
detectors for medical diagnosis, and tailor-made radiopharmaceutical
agents. The basic research technologies growing out of this program
offer applications for study, detection, diagnosis and early
intervention of natural causes of disease; as well as of biochemical,
bacterial, and viral health risks from biological and/or gross
environmental insults such as bioterrorism.
The modern era of nuclear medicine is an outgrowth of the original
charge of the Atomic Energy Commission (AEC), ``to exploit nuclear
energy to promote human health.'' Today the program through
radiopharmaceutical, molecular nuclear medicine and multimodal imaging
systems research, seeks to develop new applications of radiotracers and
radionuclide detectors in diagnosis and treatment by integrating the
latest concepts and developments in chemistry, pharmacology, genomic
sciences and transgenic animal models, structural, computational and
molecular biology, and instrumentation.
Molecules directing or affected by homeostatic controls always
interact and, thus, are targets for specific molecular substrates. The
substrate molecules can be tailored to fulfill a specific need and
labeled with appropriate radioisotopes to become measurable in real
time in the body on their way to, and in interaction with their targets
allowing the analysis of molecular, cellular and metabolic organ
functions in health and disease. The function of radiopharmaceuticals
at various sites in the body is imaged by nuclear medical instruments,
such as, gamma cameras and positron emission tomographs (PET). This
type of imaging refines diagnostic differentiation at molecular,
cellular and metabolic organ function levels between health and
disease, and among various diseases such as of the heart, brain and
cancer, often leading to more effective therapy.
New technological advancements have offered a paradigm shift in the
current level of nuclear medicine research challenges and
opportunities. Molecular nuclear medicine techniques can permit
analysis of the cellular elements as markers of genetic manipulations,
cell transformations, organ and tissue regeneration and progression of
the disease, and provide insights to molecular pathways of disease and
cell function. Such studies are therefore a major focus of this
program.
Breakthrough research in the biology of inter-organ and tissue cell
repopulation and transformation has offered new paradigms for
radiotracer imaging research in resolving the issues of progenitor cell
administration including their trafficking, biodistribution, fate and
progeny in organ and tissue regeneration, repair and replacement, with
wide applications to human disease states such as neurogenesis,
myogenesis, hematopoiesis, including stroke, ischemic heart disease,
Parkinson's disease, hematopoetic disorders and cancers. This NRI
specific program announcement offers challenging research opportunities
for new radiotracer technology innovations for emerging new clinical
research needs and medical applications.
Program Funding
It is anticipated that approximately $2 million will be available
for multiple grant awards during Fiscal Year 2002, contingent upon the
availability of appropriated funds. Previous awards have ranged from
$200,000 per year up to $400,000 per year (direct plus indirect costs)
with terms lasting up to three years. Similar award sizes are
anticipated for new grants. Applications may request project support up
to three years, with out-year support contingent on the availability of
funds, progress of the research and programmatic needs.
Preapplications
A brief preapplication should be submitted. The preapplication
should identify, on the cover sheet, the title of the project, the
institution, principal investigator name, address, telephone, fax, and
E-mail address. The preapplication should consist of two to three pages
identifying and describing the research objectives, methods for
accomplishment, and the key members of the scientific team responsible
for undertaking this effort. Preapplications will be evaluated relative
to the scope and research needs of this program notice.
Merit Review
Applications will be subjected to scientific merit review (peer
review) and will be evaluated against the following evaluation criteria
listed in descending order of importance as codified at 10 CFR
605.10(d):
1. Scientific and/or Technical Merit of the Project;
2. Appropriateness of the Proposed Method or Approach;
3. Competency of Applicant's Personnel and Adequacy of Proposed
Resources; and
4. Reasonableness and Appropriateness of the Proposed Budget.
The evaluation will include program policy factors such as the
relevance of the proposed research to the terms of the announcement and
the agency's programmatic needs. Note, external peer reviewers are
selected with regard to both their scientific expertise and the absence
of conflict-of-interest issues. Non-federal reviewers may be used, and
submission of an application constitutes agreement that this is
acceptable to the investigator(s) and the submitting institution.
Submission Information
Information about the development, submission of applications,
eligibility, limitations, evaluation, the selection process, and other
policies and procedures may be found in 10 CFR Part 605, and in the
Application Guide for the Office of Science Financial Assistance
Program. Electronic access to the Guide and required forms is made
available via the World Wide Web at: http://www.science.doe.gov/production/grants/grants.html. DOE is under no obligation to pay for
any costs associated with the preparation or submission of applications
if an award is not made.
In addition, for this Notice, the Project Description must be 20
pages or less, exclusive of attachments, and the application must
contain a Table of Contents, an abstract or project summary, letters of
intent from collaborators (if any), and short curriculum vitae
consistent with National Institutes of Health guidelines. On the SC
grant face page, form DOE F4650.2, in block 15, also provide the
[[Page 10180]]
PI's phone number, fax number, and E-mail address.
DOE policy requires that potential applicants adhere to 10 CFR 745
``Protection of Human Subjects'', or such later revision of those
guidelines as may be published in the Federal Register.
The Office of Science as part of its grant regulations requires at
10 CFR 605.11(b) that a recipient receiving a grant and performing
research involving recombinant DNA molecules and/or organisms and
viruses containing recombinant DNA molecules shall comply with NIH
``Guidelines for Research Involving Recombinant DNA Molecules,'' which
is available via the world wide web at: http://www.niehs.nih.gov/odhsb/biosafe/nih/rdna-apr98.pdf, (59 FR 34496, July 5, 1994,) or such later
revision of those guidelines as may be published in the Federal
Register.
The Catalog of Federal Domestic Assistance Number for this
program is 81.049, and the solicitation control number is ERFAP 10
CFR part 605.
Issued in Washington, DC, on February 28, 2002.
John Rodney Clark,
Associate Director of Science for Resource Management.
[FR Doc. 02-5305 Filed 3-5-02; 8:45 am]
BILLING CODE 6450-02-U