[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 4632]]
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, joanne.corcoran@oer.doe.gov.
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:
joanne.corcoran@oer.doe.gov. Electronic access to ER's Financial
Assistance Guide is possible via the Internet using
[[Page 4633]]
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
