[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