[Federal Register Volume 61, Number 26 (Wednesday, February 7, 1996)]
[Notices]
[Pages 4631-4633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2636]



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DEPARTMENT OF ENERGY

Energy Research Financial Assistance Program Notice 96-09: Human 
Genome Program; Ethical, Legal, and Social Implications

AGENCY: U.S. Department of Energy (DOE).

ACTION: Notice inviting grant applications.

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SUMMARY: The Office of health and Environmental Research (OHER) of the 
Office of Energy Research (ER), U.S. Department of Energy, hereby 
announces its interest in receiving applications in support of the 
Ethical, Legal, and Social Implications (ELSI) subprogram of the Human 
Genome Program (HGP). This program 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 encompasses research grants that address ethical, legal, and 
social issues that may arise from the use of information and knowledge 
resulting from the HGP.

DATES: Potential applicants are strongly encouraged to submit a brief 
preapplication. All preapplications 

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referencing Program Notice 96-09, should be received by DOE by 4:30 
P.M. E.S.T., March 28, 1996. A response discussing the potential 
program relevance of a formal application generally will be 
communicated to the applicant within 30 days of receipt. The deadline 
for receipt of formal applications submitted in response to this notice 
must be received by 4:30 p.m., E.D.T., July 11, 1996, to be accepted 
for merit review in September 1996 and to permit timely consideration 
for award in fiscal year 1997.

ADDRESSES: Preapplications referencing Program Notice 96-09 should be 
sent to Dr. Daniel W. Drell, U.S. Department of Energy, Office of 
Health and Environmental Research, ER-72, 19901 Germantown Road, 
Germantown, MD 20874-1290.
    After receiving notification from DOE concerning successful 
preapplications, applicants may prepare formal applications and send 
them 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 96-09. The above address for formal 
applications also must be used when submitting formal applications by 
U.S. Postal Service Express mail, and commercial mail delivery service, 
or when handcarried by the applicant.

FOR FURTHER INFORMATION CONTACT:
Dr. Daniel W. Drell, U.S. Department of Energy, Office of health and 
Environmental Research, ER-72, 19901 Germantown Road, Germantown, MD 
20874-1290, by telephone (301) 903-6488, by FAX (301) 903-8521, or 
preferably by E-mail, [email protected].

SUPPLEMENTARY INFORMATION: The DOE encourages the submission of 
applications to conduct research on privacy and confidentiality issues 
from the creation, use, maintenance, and disclosure of genetic 
information. This may include (but is not limited to) issues of 
ownership, commercialization, and control of genetic information, and 
the protection of the privacy of genetic information in various 
settings, including the workplace. Applications should demonstrate 
knowledge of the relevant literature 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 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 address the issue 
of efficient dissemination of results to the widest appropriate 
audience. All applications involving collaborations should include 
letters of support from the potential collaborators; these letters 
should specify the contributions the collaborator intends to make if 
the application is accepted and funded.
    The DOE also solicits applications for the preparation and 
dissemination of educational materials in any appropriate medium that 
will enhance understanding of scientific, as well as the ethical, 
legal, and social aspects of the HGP among public or specified groups. 
If an educational effort for a specific group is proposed, the value to 
the HGP of that group or community should be explained in detail. In 
addition, the DOE encourages applications for the support of 
conferences focusing on the ethical, legal, and social implications of 
the HGP. Issues to be examined may include (but are not limited to) 
implications of advances in the genetic characterization of complex 
traits (e.g., disease predisposition or susceptibility genes) and the 
impacts of advances in knowledge about polygenic conditions for various 
communities potentially faced with these impacts (e.g., courts, 
schools, etc.).
    Educational and conference applications should demonstrate 
awareness of the relevant literature and include detailed plans for the 
accomplishment of project goals. In applications that propose the 
production of series for broadcast, audio-visuals, or other 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 
requests inclusion of a plan for assessment of the effectiveness of the 
proposed activities. For conference applications, a detailed and 
largely complete roster of speakers is necessary. At the completion of 
the conference, a summary or report is required. Educational and 
conference applications must also demonstrate awareness of the need to 
reach the widest appropriate audience.
    Ordinarily, DOE does not encourage applications dealing with issues 
consequent to genetic testing protocols. Additionally, 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. For applications that propose the development of college-
level curricula, DOE requests both 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 HGP 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 brief preapplication, in accordance with 10 CFR 600.10(d)(2), 
should consist of two to three pages of narrative describing the 
research project objectives and methods of accomplishment. The 
reapplications will be reviewed for relevance to the notice, and 
further instructions will be provided with the response. 
Preapplications determined by staff of the Office of Health and 
Environmental Research to be insufficiently directed at the goals of 
the notice will be returned without further review to the applicant. 
Telephone and facsimile numbers are required parts of the 
preapplication, and electronic mail addresses are desirable.
    It is anticipated that approximately $1,300,000 will be available 
for grant awards in this area during FY 1997, contingent upon 
availability of appropriated funds. Multiple year funding of grant 
awards is expected, and is also contingent upon availability of funds. 
Previous awards have ranged from $50,000 per year up to $500,000 per 
year with terms from 1 to 3 years; most awards average about $200,000 
per year for 2 or 3 years. Similar award sizes are anticipated for new 
grants.
    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 Energy Research Financial 
Assistance Program. The Application Guide is available from the U.S. 
Department of Energy, Office of Health and Environmental Research, 
Health Effects and Life Sciences Research Division, ER-72, 19901 
Germantown Road, Germantown, MD 20874-1290. Telephone requests may be 
made by calling (301) 903-6488. Internet requests can be made to: 
[email protected]. Electronic access to ER's Financial 
Assistance Guide is possible via the Internet using 

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the following E-mail address: http//www.er.doe.gov
    The Office of Energy Research, as part of its grant regulations, 
requires at 10 CFR 605.11(b) that a grantee funded by ER 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'' (59 FR 34496, July 5, 1994), or such later 
revision of those guidelines as may be published in the Federal 
Register.
    The dissemination of materials and research data in a timely manner 
is essential for progress towards the goals of the DOE HGP. The OHER 
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 OHER 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 timelines projecting progress toward achieving proposed goals.
    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 January 24, 1996.
John Rodney Clark,
Associate Director for Resource Management, Office of Energy Research.
[FR Doc. 96-2636 Filed 2-6-96; 8:45 am]
BILLING CODE 6450-01-M