[Federal Register Volume 67, Number 207 (Friday, October 25, 2002)]
[Notices]
[Pages 65542-65544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27206]


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DEPARTMENT OF ENERGY


Office of Science Financial Assistance Program Notice 03-06: 
Human Genome Program--Ethical, Legal, and Social Implications

AGENCY: 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 Science (SC), U.S. Department of Energy (DOE), hereby 
announces its interest in receiving applications in support of the 
Ethical, Legal, and Social Implications (ELSI) subprogram of the Human 
Genome Program (HGP). Applications should focus on issues of: (1) 
Genetics and the workplace, and (2) complex or multigenic traits. This 
particular research notice invites research applications that address 
ethical, legal, and social implications resulting from the use of 
information and knowledge resulting from the HGP. This notice is part 
of a transition towards a wider societal implications activity in OBER, 
linked to the Genomes to Life program and no longer focusing 
principally on human genomics.

DATES: Potential applicants are strongly encouraged to submit a brief 
preapplication. All preapplications, referencing Program Notice 03-06, 
should be received by 4:30 p.m., E.S.T., November 25, 2002. Early 
submissions are encouraged. A response discussing the potential program 
relevance and encouraging or discouraging a formal application 
generally will be communicated within 20 days of receipt.
    Formal applications submitted in response to this notice must be 
received by 4:30 p.m., E.S.T., February 13, 2003, to be accepted for 
merit review and to permit timely consideration for award in Fiscal 
Year 2003.

ADDRESSES: Preapplications, referencing Program Notice 03-06, should be 
sent to: Dr. Daniel W. Drell, Office of Biological and Environmental 
Research, SC-72/Germantown Building, U.S. Department of Energy, 1000 
Independence Avenue, SW., Washington, DC 20585-1290.
    Formal applications in response to this solicitation are to be 
electronically submitted by an authorized institutional business 
official through DOE's Industry Interactive Procurement System (IIPS) 
at: http://e-center.doe.gov/. IIPS provides for the posting of 
solicitations and receipt of applications in a paperless environment 
via the Internet. In order to submit applications through IIPS your 
business official will need to register at the IIPS website. The Office 
of Science will include attachments as part of this notice that provide 
the appropriate forms in PDF fillable format that are to be submitted 
through IIPS. Color images should be submitted in IIPS as a separate 
file in PDF format and identified as such. These images should be kept 
to a minimum due to the limitations of reproducing them. They should be 
numbered and referred to in the body of the technical scientific 
application as Color image 1, Color image 2, etc. Questions regarding 
the operation of IIPS may be e-mailed to the IIPS Help Desk at: 
center.doe.gov">HelpDesk@e-center.doe.gov or you may call the help desk at: (800) 683-
0751. Further information on the use of IIPS by the Office of Science 
is available at: http://www.sc.doe.gov/production/grants/grants.html. 
The full text of Program Notice 03-06 is available via the Internet 
using the following Web site address: http://www.sc.doe.gov/production/grants/grants.html.
    If you are unable to submit an application through IIPS please 
contact the Grants and Contracts Division, Office of Science at (301) 
903-5212 in order to gain assistance for submission through IIPS or to 
receive special approval and instructions on how to submit printed 
applications.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel W. Drell, Office of 
Biological and Environmental Research, SC-72/Germantown Building, 
Office of Science, U.S. Department of Energy, 1000 Independence Avenue, 
SW., Washington, DC 20585-1290, telephone: (301) 903-6488 or e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The DOE encourages the submission of 
applications that will address, analyze, or anticipate ELSI issues 
associated with human genome research in two broad areas:

I. Genetics and the Workplace

    Research is encouraged on the uses, impacts, implications of, and 
privacy of genetic and other disease-related information in the 
workplace. A particular emphasis of this solicitation is screening and 
monitoring programs that involve the collection and evaluation of 
worker genetic information. Examples might include surveillance 
programs (involving asymptomatic screening or testing) for exposure to 
workplace hazards (e.g., beryllium or other metals), or how testing 
results might influence policy formulation in the absence of definitive 
associations between test results and health outcomes. Research is also 
encouraged on the use of the workplace as a research venue and the 
resulting challenges for Institutional Review Boards (IRBs) that are 
responsible for the oversight of such activities. Research could 
explore historical experiences, current practices, international 
practices, the economics of, and lessons learned as they pertain to the 
collection and use of worker screening test information. Research can 
include issues arising from the creation, use,

[[Page 65543]]

maintenance, privacy, and disclosure of genetic and/or medical 
information obtained in workplace settings that can include, but are 
not limited to, workplaces at which DOE activities are taking place or 
have in the past. The final product should lead to best practices 
guidance or suggestions for policy relevant recommendations.

II. Complex or Multigenic Traits

    Research is encouraged that addresses the ethical, legal, and 
societal implications of advances in the scientific understanding of 
complex or multi-genic characteristics and conditions, (e.g., gene-
environment interactions), that result in diseases or disease 
susceptibilities. Conditions may include, but are not limited to, 
behavioral conditions, diseases of aging, vulnerability to substance 
abuse, susceptibility to workplace exposure hazards (chemicals or 
radiation), or other common conditions with a partial genetic basis. 
This research may address:
    (1) Studies that explore the novel ethical, legal, and social 
issues raised by research on, and new insights into, complex 
conditions.
    (2) The responses of institutions (e.g., courts, employers, 
financial institutions, companies or company health officers, schools, 
etc., including Federal Agencies) that must deal with ``genetic 
uncertainty,'' (e.g., uncertainty about the significance of results of 
screening for susceptibility genes, uncertainty about the role of yet-
undefined environmental influences, and uncertainty about the 
implications of different alleles at highly polymorphic genes when 
those alleles are not fully characterized).
    All applications should demonstrate knowledge of the relevant 
literature, any related completed activities, and should include 
detailed plans for the gathering and analysis of factual information 
and the associated ethical, legal, and social implications. All 
applications should include, where appropriate, detailed discussion of 
human subjects protection issues, (e.g., storage of, manipulation of, 
and access to personal genetic data). Provisions to ensure the 
inclusion of women, minorities, and potentially disabled individuals 
must be described, unless specific exclusions are scientifically 
necessary and justified in detail. All proposed research applications 
should provide a plan for rigorous assessments to evaluate progress or 
outcomes. Where a product (guidelines, recommendations, documents, 
etc.) is the result, dissemination plans including timelines must be 
discussed. All applications should include letters of agreement to 
collaborate from potential collaborators; these letters should specify 
the contributions the collaborators intend to make if the application 
is accepted and funded.
    In previous solicitations in this program, a focus on educational 
efforts for specific groups was included. Here, applications for the 
development and dissemination of educational materials will not be 
considered in order that OBER can encourage as high priorities those 
projects that address the explicitly stated goals of this solicitation.
    DOE does not encourage applications dealing with issues consequent 
to the initiation or implementation of genetic testing protocols. Also, 
DOE does not encourage survey-based research, unless a compelling case 
is made that this methodology is critical to address an issue of 
uncommon significance. Applications for the writing of scholarly 
publications or books should include justifications for the relevance 
of the publications or books, to the goals of this notice, as well as 
discussion of the estimated readership and impact. DOE ordinarily will 
not provide unlimited support for a funded program and thus strongly 
encourages the inclusion of plans for transition to self-sustaining 
status.

Additional Request for Small Grants

    The DOE also encourages small grant applications, to a maximum of 
$33,000 total costs, for innovative and exploratory activities within 
the previously described areas. Such exploratory grants could be used 
to carry out pilot or investigative research on an issue consistent 
with any of the above areas of ELSI research, support a sabbatical 
leave to organize and hold a conference, or to initiate start-up 
studies that could generate preliminary data for a subsequent grant 
application. This program could be appropriate for a research scientist 
interested in exploring a related area of ELSI research, or a scholar 
conducting ELSI research of one type to explore an ELSI research topic 
of a different type. Such applications must use the standard DOE 
application forms which can be found on the Internet at: http://www.sc.doe.gov/production/grants/grants.html, but the description of 
research activities should not be more than five pages and curriculum 
vitae should not exceed two pages. These small grants, which will be 
peer reviewed, will not extend beyond one year from the award date. It 
is expected that up to five of these awards might be made in Fiscal 
Year 2003. As with larger applications to this notice, applications are 
required to be submitted electronically through the IIPS.

Program Funding

    It is anticipated that approximately $600,000 will be available for 
multiple grant awards (including any small grants) to be made during 
Fiscal Year 2003, contingent upon the availability of appropriated 
funds. Multiple year funding of grant awards is expected, and is also 
contingent upon the availability of funds. Previous awards have ranged 
from $50,000 per year up to $500,000 per year with terms from one to 
three years; most awards average about $200,000 per year for two or 
three years (not applicable for any small grants as stated above.) 
Similar award sizes are anticipated for new grants. Generally, 
conference awards do not exceed $25,000 and indirect costs are not 
allowed as part of conference grant awards.

Collaboration

    Applicants are encouraged to collaborate with researchers in other 
institutions, such as universities, DOE National Laboratories, 
industry, non-profit organizations, other federal laboratories and 
federally funded research and development centers (FFRDCs), where 
appropriate, and to incorporate cost sharing and/or consortia wherever 
feasible. Additional information on collaboration is available in the 
Application Guide for the Office of Science Financial Assistance 
Program that is available via the Internet at: http://www.sc.doe.gov/production/grants/Colab.html.

Preapplications

    A brief preapplication should 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 for responsiveness to the scope and research needs described 
in this notice. 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.

Merit Review

    Applications will be subjected to a scientific merit review (peer 
review) and will be evaluated against the following

[[Page 65544]]

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 development and submission of applications, 
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 Science Financial Assistance 
Program. Electronic access to the Guide and required forms is made 
available via the World Wide Web at: http://www.sc.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. 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 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 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 October 21, 2002.
John Rodney Clark,
Associate Director of Science for Resource Management.
[FR Doc. 02-27206 Filed 10-24-02; 8:45 am]
BILLING CODE 6450-03-P