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DEPARTMENT OF ENERGY For more information about the Office of Science, go to Office of Science |
To DOE National Laboratories LAB 02-21 Medical Applications Program
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 proposals 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 researchers should clearly demonstrate the relevance and important clinical
need of the research proposed. Special consideration will be given to proposals 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.
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
researchers 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
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.
DATES: Potential researchers are encouraged to submit a brief preproposal before preparing a
formal proposal. All preproposals in response to Program Announcement LAB 02-21 should be
received by DOE by 4:30 p.m., E.S.T., April 1, 2002. A response encouraging or discouraging
the submission of a formal proposal will be communicated via email by April 15, 2002.
Formal proposals submitted in response to this announcement 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: Preproposals referencing Program Announcement LAB 02-21 must be sent via
electronic mail to: sharon.betson@science.doe.gov or by FAX to (301) 903-0567.
Formal proposals referencing Program Announcement LAB 02-21, should be forwarded to: U.S.
Department of Energy, Office of Science, Medical Sciences Division, SC-73, Office of
Biological and Environmental Research, 19901 Germantown Road, Germantown, MD 20874-
1290, ATTN: Program Announcement LAB 02-21. This address must also be used when
submitting proposals by U.S. Postal Service Express Mail or any other commercial overnight
delivery service, or hand-carried by the proposer. An original and seven copies of the proposal
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: prem.srivastava@science.doe.gov.
Program Funding
It is anticipated that approximately $2 million will be available for multiple 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 awards. Proposals 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.
Preproposals
A brief preproposal should be submitted. The preproposal should identify, on the cover sheet, the
title of the project, the institution, principal investigator name, address, telephone, fax, and E-
mail address. The preproposal 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. Preproposals will be evaluated relative to the scope and
research needs of this program notice.
Submission Information
Researchers are expected to follow instructions in the Office of Science Guide for Preparation of
Scientific/Technical Proposals to be Submitted by National Laboratories (attached below).
DOE is under no obligation to pay for any costs associated with the preparation or submission of
proposals if an award is not made.
In addition, for this Announcement, the Project Description must be 20 pages or less, exclusive
of attachments, and the proposal 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 cover page also provide the PI's phone number,
fax number, and E-mail address.
DOE policy requires that potential researchers 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 requirements for reporting, protection of human and animal subjects and related special
matters can be found on the World Wide Web at:
http://www.science.doe.gov/production/grants/Welfare.html.
Any recipient of an award from the Office of Science, performing research involving
recombinant DNA molecules and/or organisms and viruses containing recombinant DNA
molecules shall comply with the National Institutes of Health "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 instructions and format described below should be followed. Reference Program
Announcement LAB 02-21 on all submissions and inquiries about this program.
GUIDE FOR PREPARATION OF SCIENTIFIC/TECHNICAL PROPOSALS TO BE SUBMITTED BY NATIONAL LABORATORIES Proposals from National Laboratories submitted to the Office of Science (SC) as a result of this program announcement will follow the Department of Energy Field Work Proposal process with additional information requested to allow for scientific/technical merit review. The following guidelines for content and format are intended to facilitate an understanding of the requirements necessary for SC to conduct a merit review of a proposal. Please follow the guidelines carefully, as deviations could be cause for declination of a proposal without merit review. 1. Evaluation Criteria Proposals will be subjected to formal merit review (peer review) and will be evaluated against the following criteria which are listed in descending order of importance:
Appropriateness of the proposed method or approach Competency of the personnel and adequacy of the proposed resources Reasonableness and appropriateness of the proposed budget 2. Summary of Proposal Contents
Proposal Cover Page Table of Contents Abstract Narrative Literature Cited Budget and Budget Explanation Other support of investigators Biographical Sketches Description of facilities and resources Appendix An original and seven copies of the formal proposal/FWP must be submitted. 3. Detailed Contents of the Proposal Proposals must be readily legible, when photocopied, and must conform to the following three requirements: the height of the letters must be no smaller than 10 point with at least 2 points of spacing between lines (leading); the type density must average no more than 17 characters per inch; the margins must be at least one-half inch on all sides. Figures, charts, tables, figure legends, etc., may include type smaller than these requirements so long as they are still fully legible.
3.1 Field Work Proposal Format (Reference DOE Order 5700.7C) The Field Work Proposal (FWP) is to be prepared and submitted consistent with policies of the investigator's laboratory and the local DOE Operations Office. Additional information is also requested to allow for scientific/technical merit review. Laboratories may submit proposals directly to the SC Program office listed above. A copy should also be provided to the appropriate DOE operations office. 3.2 Proposal Cover Page The following proposal cover page information may be placed on plain paper. No form is required.
SC Program announcement title Name of laboratory Name of principal investigator (PI) Position title of PI Mailing address of PI Telephone of PI Fax number of PI Electronic mail address of PI Name of official signing for laboratory* Title of official Fax number of official Telephone of official Electronic mail address of official Requested funding for each year; total request Use of human subjects in proposed project:
Signature of official, date of signature* *The signature certifies that personnel and facilities are available as stated in the proposal, if the project is funded. Provide the initial page number for each of the sections of the proposal. Number pages consecutively at the bottom of each page throughout the proposal. Start each major section at the top of a new page. Do not use unnumbered pages and do not use suffices, such as 5a, 5b. 3.4 Abstract Provide an abstract of no more than 250 words. Give the broad, long-term objectives and what the specific research proposed is intended to accomplish. State the hypotheses to be tested. Indicate how the proposed research addresses the SC scientific/technical area specifically described in this announcement. 3.5 Narrative The narrative comprises the research plan for the project and is limited to 25 pages. It should contain the following subsections: Background and Significance: Briefly sketch the background leading to the present proposal, critically evaluate existing knowledge, and specifically identify the gaps which the project is intended to fill. State concisely the importance of the research described in the proposal. Explain the relevance of the project to the research needs identified by the Office of Science. Include references to relevant published literature, both to work of the investigators and to work done by other researchers. Preliminary Studies: Use this section to provide an account of any preliminary studies that may be pertinent to the proposal. Include any other information that will help to establish the experience and competence of the investigators to pursue the proposed project. References to appropriate publications and manuscripts submitted or accepted for publication may be included. Research Design and Methods: Describe the research design and the procedures to be used to accomplish the specific aims of the project. Describe new techniques and methodologies and explain the advantages over existing techniques and methodologies. As part of this section, provide a tentative sequence or timetable for the project. Subcontract or Consortium Arrangements: If any portion of the project described under "Research Design and Methods" is to be done in collaboration with another institution, provide information on the institution and why it is to do the specific component of the project. Further information on any such arrangements is to be given in the sections "Budget and Budget Explanation", "Biographical Sketches", and "Description of Facilities and Resources". 3.6 Literature Cited List all references cited in the narrative. Limit citations to current literature relevant to the proposed research. Information about each reference should be sufficient for it to be located by a reviewer of the proposal. 3.7 Budget and Budget Explanation A detailed budget is required for the entire project period, which normally will be three years, and for each fiscal year. It is preferred that DOE's budget page, Form 4620.1 be used for providing budget information*. Modifications of categories are permissible to comply with institutional practices, for example with regard to overhead costs. A written justification of each budget item is to follow the budget pages. For personnel this should take the form of a one-sentence statement of the role of the person in the project. Provide a detailed justification of the need for each item of permanent equipment. Explain each of the other direct costs in sufficient detail for reviewers to be able to judge the appropriateness of the amount requested. Further instructions regarding the budget are given in section 4 of this guide. * Form 4620.1 is available at web site: http://www.sc.doe.gov/production/grants/forms.html 3.8 Other Support of Investigators Other support is defined as all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors. Information on active and pending other support is required for all senior personnel, including investigators at collaborating institutions to be funded by a subcontract. For each item of other support, give the organization or agency, inclusive dates of the project or proposed project, annual funding, and level of effort devoted to the project. 3.9 Biographical Sketches This information is required for senior personnel at the laboratory submitting the proposal and at all subcontracting institutions. The biographical sketch is limited to a maximum of two pages for each investigator. 3.10 Description of Facilities and Resources Describe briefly the facilities to be used for the conduct of the proposed research. Indicate the performance sites and describe pertinent capabilities, including support facilities (such as machine shops) that will be used during the project. List the most important equipment items already available for the project and their pertinent capabilities. Include this information for each subcontracting institution, if any. 3.11 Appendix Include collated sets of all appendix materials with each copy of the proposal. Do not use the appendix to circumvent the page limitations of the proposal. Information should be included that may not be easily accessible to a reviewer. Reviewers are not required to consider information in the Appendix, only that in the body of the proposal. Reviewers may not have time to read extensive appendix materials with the same care as they will read the proposal proper. The appendix may contain the following items: up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project, but not generally available to the scientific community; and letters from investigators at other institutions stating their agreement to participate in the project (do not include letters of endorsement of the project).
4. Detailed Instructions for the Budget 4.1 Salaries and Wages List the names of the principal investigator and other key personnel and the estimated number of person-months for which DOE funding is requested. Proposers should list the number of postdoctoral associates and other professional positions included in the proposal and indicate the number of full-time-equivalent (FTE) person-months and rate of pay (hourly, monthly or annually). For graduate and undergraduate students and all other personnel categories such as secretarial, clerical, technical, etc., show the total number of people needed in each job title and total salaries needed. Salaries requested must be consistent with the institution's regular practices. The budget explanation should define concisely the role of each position in the overall project. 4.2 Equipment DOE defines equipment as "an item of tangible personal property that has a useful life of more than two years and an acquisition cost of $25,000 or more." Special purpose equipment means equipment which is used only for research, scientific or other technical activities. Items of needed equipment should be individually listed by description and estimated cost, including tax, and adequately justified. Allowable items ordinarily will be limited to scientific equipment that is not already available for the conduct of the work. General purpose office equipment normally will not be considered eligible for support. 4.3 Domestic Travel The type and extent of travel and its relation to the research should be specified. Funds may be requested for attendance at meetings and conferences, other travel associated with the work and subsistence. In order to qualify for support, attendance at meetings or conferences must enhance the investigator's capability to perform the research, plan extensions of it, or disseminate its results. Consultant's travel costs also may be requested. 4.4 Foreign Travel Foreign travel is any travel outside Canada and the United States and its territories and possessions. Foreign travel may be approved only if it is directly related to project objectives. 4.5 Other Direct Costs The budget should itemize other anticipated direct costs not included under the headings above, including materials and supplies, publication costs, computer services, and consultant services (which are discussed below). Other examples are: aircraft rental, space rental at research establishments away from the institution, minor building alterations, service charges, and fabrication of equipment or systems not available off-the-shelf. Reference books and periodicals may be charged to the project only if they are specifically related to the research. a. Materials and Supplies The budget should indicate in general terms the type of required expendable materials and supplies with their estimated costs. The breakdown should be more detailed when the cost is substantial. b. Publication Costs/Page Charges The budget may request funds for the costs of preparing and publishing the results of research, including costs of reports, reprints page charges, or other journal costs (except costs for prior or early publication), and necessary illustrations. c. Consultant Services Anticipated consultant services should be justified and information furnished on each individual's expertise, primary organizational affiliation, daily compensation rate and number of days expected service. Consultant's travel costs should be listed separately under travel in the budget. d. Computer Services The cost of computer services, including computer-based retrieval of scientific and technical information, may be requested. A justification based on the established computer service rates should be included. e. Subcontracts Subcontracts should be listed so that they can be properly evaluated. There should be an anticipated cost and an explanation of that cost for each subcontract. The total amount of each subcontract should also appear as a budget item. 4.6 Indirect Costs Explain the basis for each overhead and indirect cost. Include the current rates.
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