[Federal Register Volume 63, Number 114 (Monday, June 15, 1998)]
[Notices]
[Pages 32649-32651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15830]


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DEPARTMENT OF ENERGY

Office of Energy Research


Energy Research Financial Assistance Program Notice 98-19: 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 Energy Research (ER), 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). 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 98-19, 
should be received by 4:30 p.m., E.D.T., July 30, 1998. 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.D.T., September 17, 1998, to be accepted for 
merit review in November and to permit timely consideration for award 
in Fiscal Year 1999.

ADDRESSES: Preapplications, referencing Program Notice 98-19, should be 
sent to: Dr. Daniel W. Drell, Office of Biological and Environmental 
Research, ER-72, 19901 Germantown Road, Germantown, MD 20874-1290.
    Formal applications, referencing Program Notice 98-19, should be 
forwarded 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 98-19. 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, ER-72, Office of Energy 
Research, 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 98-19 is 
available via the Internet using the following web site address: http:/
/www.er.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. The DOE particularly encourages 
research in four broad areas:
    I. The uses, impacts, implications of, and privacy of genetic 
information in the workplace, particularly screening and monitoring 
programs that involve the collection and evaluation of genetic 
information, and the use of the workplace as a research venue. Research 
is encouraged that would explore historical experiences, current 
practices, and lessons learned as they pertain to the collection and 
use of worker genetic information. This 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. Access to, and protection of, genetic information particularly 
information stored in computerized databases, or obtained from stored 
human tissue or sample archives. Research is encouraged to explore 
confidentiality of genetic data in databanks and databases, the 
anonymization of genetic records and samples, and the intellectual 
property protection of genetic information and genome research tools, 
technologies, and resources.
    III. The preparation and dissemination of 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. An interest of this notice is the education of 
Institutional Review Boards (IRB) that review protocols involving the 
gathering of genetic information and genome investigators who work with 
human subjects or materials from which genetic information can be 
obtained. Additional groups of interest could include judges, the 
media, policy makers, and DOE employees and contractors.
    IV. The ethical, legal, and societal implications of advances in 
the scientific understanding of complex or multi-genic characteristics 
and conditions, gene-environment interactions that result in diseases 
or disease susceptibilities, and human polymorphisms. In particular, 
the DOE is interested in studies identifying the responses of 
institutions (e.g., courts, employers, companies, schools, etc.) that 
must deal with ``genetic uncertainty,'' e.g., lack of certainty of the 
results of screening for susceptibility genes, uncertain consequences 
of yet-undefined environmental influences, and highly polymorphic genes 
whose numerous 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 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 as well as a time line for their production and dissemination. 
In the absence of tangible products, rigorous assessments must be 
included to facilitate evaluation of progress. 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

[[Page 32650]]

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 outcomes 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 local 
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.

Program Funding

    It is anticipated that approximately $1,500,000 will be available 
for multiple grant awards to be made during Fiscal Year 1999, 
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. 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.
    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 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

[[Page 32651]]

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 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.
    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. 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.
    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, DC, on June 4, 1998.
John Rodney Clark,
Associate Director for Resource Management, Office of Energy Research.
[FR Doc. 98-15830 Filed 6-12-98; 8:45 am]
BILLING CODE 6450-01-P