[Federal Register Volume 63, Number 31 (Tuesday, February 17, 1998)]
[Notices]
[Pages 7775-7777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3842]


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DEPARTMENT OF ENERGY

Office of Energy Research


Energy Research Financial Assistance Program Notice 98-11; 
Cellular Biology Research Program--Mechanisms of Cellular Responses to 
Low Dose, Low Dose-Rate Exposures

AGENCY: Office of Energy Research, U.S. Department of Energy.

ACTION: Notice inviting grant applications.

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SUMMARY: The Office of Biological and Environmental Research (OBER) of 
the Office of Energy Research (ER), U.S. Department of Energy (DOE), 
hereby announces its interest in receiving applications for research 
for support of the Cellular Biology Research Program. This Program is a 
coordinated multidisciplinary research effort to develop creative, 
innovative approaches that will provide a better scientific basis for 
understanding exposures and risks to humans associated with low level 
exposures to radiation and chemicals. Using modern molecular tools, 
this research will provide information that will be used to decrease 
the uncertainty of risk at low levels, help determine the shape of the 
dose-response relationships after low level exposure, and achieve 
acceptable levels of human health protection at the lowest possible 
cost.

DATES: Potential applicants are encouraged to submit a brief 
preapplication. All preapplications, referencing Program Notice 98-11, 
should be received by DOE by 4:30 P.M. E.S.T., March 26, 1998. A 
response to the preapplications discussing the potential program 
relevance of a formal application generally will be communicated within 
7 days of receipt.
    The deadline for receipt of formal applications is 4:30 P.M., 
E.D.T., May 7, 1998, in order to be accepted for merit review and to 
permit timely consideration for award in FY 1999.

ADDRESSES: Preapplications, referencing Program Notice 98-11, should be 
sent by E-mail to [email protected], however, preapplications 
will also be accepted if mailed to the following address: Ms. Joanne 
Corcoran, Office of Biological and Environmental Research, ER-72, U.S. 
Department of Energy, 19901 Germantown Road, Germantown, MD 20874-1290.
    Formal applications, referencing Program Notice 98-11, should be 
sent to: U.S. Department of Energy, Office of Energy Research, Grants 
and Contracts Division, ER-64, 19901 Germantown Road, Germantown, MD 
20874-1290, ATTN: Program Notice 98-11, Ms. Debbie Greenawalt. This 
address must be used when submitting applications by U.S. Postal 
Service Express, any commercial mail delivery service, or when hand 
carried by the applicant.

FOR FURTHER INFORMATION CONTACT: Dr. Susan Rose, telephone: (301) 903-
4731 or Dr. David Thomassen, telephone: (301) 903-9817, Office of 
Biological and Environmental Research, ER-72, U.S. Department of 
Energy, 19901 Germantown Road, Germantown, MD 20874-1290.

SUPPLEMENTARY INFORMATION: Current standards for occupational and 
residential exposures to radiation and chemicals are based on linear, 
no-threshold models of risk that drive regulatory decisions and 
estimations of cancer risk. Linear, no-threshold models assume that 
risk is always proportional to dose, that there is no risk only when 
there is no dose, and that even a single molecule or radiation induced 
ionization can cause cancer or disease. However, the scientific basis 
for these assumptions is limited and uncertain at very low doses and 
dose rates.
    Much scientific evidence suggests that the risks from exposure to 
low doses or low dose-rates of radiation and chemicals may be better 
described by a non-linear, dose-response relationship. This evidence 
includes long term human and animal studies and research at the 
cellular and molecular level on the DNA repair capabilities of cells 
and tissues, ``bystander'' effects associated with low dose exposures, 
the effects of exposure-induced gene expression, the effects of a 
cell's micro environment on its response to low dose exposures, and 
studies of the multi-step nature of cancer development. A more 
definitive understanding of the biological responses induced by low 
dose, low dose-rate exposures is needed to clarify the role played by 
these and other cell responses and capabilities in determining risk.
    This research program will focus on understanding the mechanisms of 
molecular and cellular responses to low dose, low dose-rate exposures 
to radiation and chemicals to improve the scientific underpinning for 
estimating risks from these exposures. The program will include 
research to identify and characterize: (1) The genes and gene products 
that determine and affect these cellular responses induced at low dose 
and dose-rates; (2) the role played by these genes and gene products in 
determining individual differences in susceptibility to low dose, low 
dose-rate exposures; and (3) methods to synthesize or model molecular 
level information on genes and gene products into overall health risk. 
The program will also communicate research results to regulators and 
legislators. The goal of this research program is the development of 
scientifically defensible tools and approaches for determining risk 
that are widely used, accepted, and understood.
    Research is encouraged in a number of areas including, but not 
limited to:

[[Page 7776]]

     The effects of and reactions to reactive oxygen species at 
low doses and/or dose rates;
     The role of gene induction, DNA repair, apoptosis, and the 
immune system in mediating responses to low dose and/or low dose-rate 
exposures;
     The nature and significance of ``bystander'' effects in 
determining cell and tissue responses to low dose and/or low dose-rate 
exposures;
     The role of cell and tissue microenvironments in 
determining cell and tissue responses to low dose and/or low dose-rate 
exposures;
     Development of computational techniques, e.g., algorithms 
and advanced mathematical approaches, for use in determining risk, that 
model new information from cellular and molecular studies together with 
available data from epidemiologic and animal studies.
    A Lead Scientist will be selected from among all investigators who 
are successful in receiving research funds in this program. This 
research program will be directed by a program manager from OBER, who 
will be responsible for providing support and overall direction, 
including determining the relevance of the goals and objectives of the 
program. The Lead Scientist will provide scientific leadership to the 
community of the researchers in the research program. Applicants 
interested in being considered as a Lead Scientist for the low dose 
research program should indicate their interest in their research 
application. In addition to the information requested in the 
Application Guide, applicants should supplement their applications by 
describing their qualifications to serve as a Lead Scientist for this 
program. The supplemental information should be provided as a separate 
appendix not attached to the main application. Interested applicants 
should demonstrate their understanding of the needs for and the uses of 
the types of scientific information likely to be developed in this 
research program. They should demonstrate their understanding of 
previous epidemiologic and experimental studies involving low dose, low 
dose-rate exposures to radiation or chemicals. Finally, interested 
applicants should demonstrate their knowledgeability of research 
opportunities and capabilities at National Laboratories, universities, 
and industry in the area of molecular and cellular responses to low 
dose, low dose-rate exposures.

Program Funding

    It is anticipated that up to $1.5 million will be available for 
grant awards during FY 1998, contingent upon the availability of funds. 
An additional $0.5 million may be available during FY 1999, contingent 
upon the availability of funds. Multiple year funding of grant awards 
is expected, and is also contingent upon the availability of funds. It 
is expected that most awards will be from one to three years and will 
range from $200,000 to $400,000 per year (total costs).

Collaboration

    Applicants are encouraged to collaborate with researchers in other 
institutions, such as universities, industry, non-profit organizations, 
federal laboratories and FFRDCs, including the DOE National 
Laboratories, where appropriate, and to incorporate cost sharing and/or 
consortia wherever feasible.
    Collaborative research applications may be submitted in several 
ways:
    (1) When multiple private sector or academic organizations intend 
to propose collaborative or joint research projects, the lead 
organization may submit a single application which includes another 
organization as a lower-tier participant (subaward) who will be 
responsible for a smaller portion of the overall project. If approved 
for funding, DOE may provide the total project funds to the lead 
organization who will provide funding to the other participant via a 
subcontract arrangement. The application should clearly describe the 
role to be played by each organization, specify the managerial 
arrangements and explain the advantages of the multi-organizational 
effort.
    (2) Alternatively, multiple private sector or academic 
organizations who intend to propose collaborative or joint research 
projects may each prepare a portion of the application, then combine 
each portion into a single, integrated scientific application. A 
separate Face Page and Budget Pages must be included for each 
organization participating in the collaborative project. The joint 
application must be submitted to DOE as one package. If approved for 
funding, DOE will award a separate grant to each collaborating 
organization.
    (3) Private sector or academic organizations who wish to form a 
collaborative project with a DOE FFRDC may not include the DOE FFRDC in 
their application as a lower-tier participant (subaward). Rather, each 
collaborator may prepare a portion of the proposal, then combine each 
portion into a single, integrated scientific proposal. The private 
sector or academic organization must include a Face Page and Budget 
Pages for its portion of the project. The FFRDC must include separate 
Budget Pages for its portion of the project. The joint proposal must be 
submitted to DOE as one package. If approved for funding, DOE will 
award a grant to the private sector or academic organization. The FFRDC 
will be funded, through existing DOE contracts, from funds specifically 
designated for new FFRDC projects. DOE FFRDCs will not compete for 
funding already designated for private sector or academic 
organizations. Other Federal laboratories who wish to form 
collaborative projects may also follow guidelines outlined in this 
section.

Preapplications

    A brief preapplication may be submitted. The preapplication should 
identify on the cover sheet the institution, Principal Investigator 
name, address, telephone, fax and E-mail address, title of the project, 
and the field of scientific research. The preapplication should consist 
of a two to three page narrative describing the research project 
objectives and methods of accomplishment. These will be reviewed 
relative to the scope and research needs of the DOE Cellular Biology 
Research Program.
    Preapplications are strongly encouraged but not required prior to 
submission of a full application. Please note that notification of a 
successful preapplication is not an indication that an award will be 
made in response to the formal application.
    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
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 
an 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.
    Information about the development and submission of applications,

[[Page 7777]]

eligibility, limitations, evaluation, selection process, and other 
policies and procedures may be found in 10 CFR Part 605, and in the 
Application Guide for the Office of Energy Research Financial 
Assistance Program. Electronic access to the Guide and required forms 
is made available via the World Wide Web at: http://www.er.doe.gov/
production/grants/grants.html. The Project Description must be 25 pages 
or less, exclusive of attachments. The application must contain an 
abstract or project summary, letters of intent from collaborators, and 
short curriculum vitaes consistent with NIH guidelines.
    Energy Research, as part of its grant regulations, requires at 10 
CFR 605.11(b) that a recipient receiving a grant to perform 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/nih97-1.html, (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, D.C. February 6, 1998.
John Rodney Clark,
Associate Director for Resource Management, Office of Energy Research.
[FR Doc. 98-3842 Filed 2-13-98; 8:45 am]
BILLING CODE 6450-01-P