[Federal Register Volume 65, Number 241 (Thursday, December 14, 2000)]
[Notices]
[Pages 78148-78150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31890]


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DEPARTMENT OF ENERGY


Office of Science Financial Assistance Program Notice 01-13; 
Human Genome Program--Ethical, Legal, and Social Implications

AGENCY: 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 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, (2) storage of genetic information and 
tissue samples, (3) education, or (4) complex or multigenic traits. The 
HGP is a coordinated, multidisciplinary, directed research effort aimed 
at obtaining a detailed understanding of the human genome at the 
molecular level. This particular research notice invites research 
grants that address ethical, legal, and social implications from the 
use of information and knowledge resulting from the HGP.

DATES: Potential applicants are strongly encouraged to submit a brief 
preapplication. All preapplications, referencing Program Notice 01-13, 
should be received by 4:30 p.m., EST, January 19, 2001. 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., EST, March 29, 2001, to be accepted for merit 
review and to permit timely consideration for award in Fiscal Year 
2001.

ADDRESSES: Preapplications, referencing Program Notice 01-13, should be 
sent to: Dr. Daniel W. Drell, Office of Biological and Environmental 
Research, SC-72, 19901 Germantown Road, Germantown, MD 20874-1290.
    Formal applications, referencing Program Notice 01-13, 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 01-13. This address also must be used when 
submitting applications by U.S. Postal Service Express Mail, or any 
commercial mail delivery service, or when hand carried by the 
applicant. An original and seven copies of the application must be 
submitted.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel W. Drell, Office of 
Biological and Environmental Research, SC-72, Office of Science, U.S. 
Department of Energy, 19901 Germantown Road, Germantown, MD 20874-1290, 
telephone: (301) 903-6488 or E-mail: [email protected]. The 
full text of Program Notice 01-13 is available via the World Wide Web 
using the following web site address: http://www.sc.doe.gov/production/grants/grants.html.

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

I. Genetics and the Workplace

    Research is encouraged on the uses, impacts, implications of, and 
privacy of genetic information in the workplace. A particular emphasis 
of this solicitation is screening and monitoring programs that involve 
the collection and evaluation of genetic information. Research is also 
encouraged on the use of the workplace as a research venue. 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 genetic information. Research can include 
issues arising from the creation, use, maintenance, privacy and 
disclosure of genetic information obtained in workplace settings that 
can include, but is not limited to, workplaces at which DOE activities 
are taking place or have in the past.

II. Storage of Information and Samples

    Research is encouraged on access to, and protection of genetic 
information stored in databases (especially computerized databases), or 
obtained from stored human tissue or sample archives. Research can 
explore threats to, issues surrounding, and protection of the 
confidentiality of genetic data in databanks and databases, ways to 
anonymize existing or new genetic records and samples, to assess the 
economics of genetic data collection, and to explore the intellectual 
property protection of genetic information and genome research tools, 
technologies, and resources. Research can also explore the privacy and 
ownership issues associated with genetic data in records collected as 
part of occupational medical surveillance, as well as in academic 
genetics research.

[[Page 78149]]

III. Education

    Research is encouraged to create and disseminate relevant 
educational materials in any appropriate medium that will enhance 
understanding of the ethical, legal, and social aspects of the HGP 
among the public or specified groups. A particular interest of this 
solicitation is the creation of innovative and novel materials to 
Institutional Review Boards (IRB) and Ethics Boards that review 
protocols involving the gathering of genetic information or from genome 
investigators who work with human subjects or materials from which 
human genetic information can be obtained. Educational efforts should 
not target specific groups that have already been the subject of past 
ELSI awards (for further information about past awards under previous 
ELSI solicitations, see http://www.ornl.gov/hgmis/research/elsi.html.)

IV. 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. Such conditions 
may include, but are not limited to, behavioral conditions, diseases of 
aging, vulnerability to substance abuse, susceptibility to workplace 
exposure hazards, or other common conditions with a partial genetic 
basis. This can include:
    (1) Gene--environment interactions that result in diseases or 
disease susceptibilities, and human polymorphisms.
    (2) Studies that explore the novel issues raised by research on 
complex conditions.
    (3) The responses of institutions (e.g., courts, employers, 
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 to disseminate results to the widest appropriate audience as 
well as a time line for their production and dissemination. In the 
absence of tangible products, rigorous assessments must be included to 
evaluate progress or outcomes. 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.
    If an educational effort for a specific group is proposed, the 
value to the Human Genome Program of that group or community should be 
explained in detail. In addition, the DOE encourages applications for 
the support of novel and innovative conferences focusing on the 
concerns addressed in this notice, e.g., privacy and access to research 
materials, workplace uses of genetic information, education of targeted 
groups such as IRBs and investigators, and susceptibility/sensitivity 
genes, and polymorphisms. Educational and conference applications 
should demonstrate awareness of the relevant literature, include 
detailed plans for the accomplishment of project goals, and clearly 
describe the outcome or ``deliverables'' from the activity. For 
conference applications, a detailed and largely complete roster of 
speakers is necessary. Educational and conference applications must 
also demonstrate awareness of the need to reach the widest appropriate 
audience, and not be focused exclusively on a local community or group. 
For all conferences supported under this notice, a summary report is 
required following the conference. In applications that propose the 
production of educational materials, the DOE requests that samples of 
previous similar work by the producers and writers be submitted along 
with the application. In applications for the support of educational 
activities, the DOE requires inclusion of a plan for assessment of the 
effectiveness of the proposed activities.
    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. DOE generally discourages applications for 
geographically limited efforts (e.g., college or school curricula that 
will not be disseminated) and requests detailed justification of the 
need for external support, beyond normal departmental and college 
resources, evidence of commitment from the parent department or 
college, and a dissemination plan. Applications for the writing of 
scholarly publications or books should include justifications for the 
relevance of the publications or book to the goals of the Human Genome 
Project, 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.
    The dissemination of materials and research data in a timely manner 
is essential for progress toward the goals of the DOE Human Genome 
Program. The OBER requires the timely sharing of resources and data. 
Applicants should, in their applications, discuss their plans for 
disseminating research results and materials that may include, where 
appropriate, publication in the open literature, wide-scale mailings, 
etc. Once OBER and the applicant have agreed upon a distribution plan, 
it will become part of the award conditions. Funds to defray the costs 
of disseminating results and materials are allowable; however, such 
requests must be sufficiently detailed and adequately justified. 
Applicants should also provide time lines projecting progress toward 
achieving proposed goals.

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

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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 nine of 
these awards might be made in FY 2001. As with larger applications to 
this notice, applications should be sent to the address given above.

Program Funding

    It is anticipated that approximately $800,000 will be available for 
multiple grant awards (including any small grants) to be made during 
Fiscal Year 2001, 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, industry, non-profit 
organizations, federal laboratories and federally funded research and 
development centers (FFRDCs), including the DOE National Laboratories, 
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 relative to the scope and research needs of the DOE's Human 
Genome 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.

Merit Review

    Applications will be subjected to a 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.

Submission Information

    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 December 4, 2000.
John Rodney Clark,
Associate Director of Science for Resource Management.
[FR Doc. 00-31890 Filed 12-13-00; 8:45 am]
BILLING CODE 6450-01-U