[Federal Register Volume 60, Number 20 (Tuesday, January 31, 1995)]
[Rules and Regulations]
[Pages 5838-5845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2344]
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DEPARTMENT OF ENERGY
Office of Environment, Safety and Health
10 CFR Part 602
Epidemiology and Other Health Studies Financial Assistance
Program
AGENCY: Office of Environment, Safety and Health, Department of Energy.
ACTION: Final rule.
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SUMMARY: The Department of Energy (DOE) Office of Environment, Safety
and Health (EH) is issuing a rule to implement an Epidemiology and
Other Health Studies Financial Assistance Program. The rule will
support EH use of financial assistance awards when they are the
appropriate instruments for programmatic activities. The rule will also
facilitate a fully open and competitive process for obtaining financial
assistance awards. This action is taken to support EH's mission to
protect the health of DOE workers, as well as other individuals
associated with energy production, transmission, and use.
EFFECTIVE DATE: The final rule is effective March 2, 1995.
FOR FURTHER INFORMATION CONTACT: Dr. Heather Stockwell, Acting
Director, Office of Epidemiology and Health Surveillance (EH-42), U.S.
Department of Energy, Washington, DC 20585; facsimile: 301-903-4677;
telephone: 301-903-3721.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. Discussion of Comments on Proposed Rule
III. Final Rule
IV. Regulatory Review
V. Review under the Regulatory Flexibility Act
VI. Review under the Paperwork Reduction Act
VII. Review under the National Environmental Policy Act
VIII. Intergovernmental Review
IX. Review under Executive Order 12612
X. Review under Executive Order 12778
XI. Catalog of Federal Assistance
I. Introduction
DOE is amending chapter II of title 10 of the Code of Federal
Regulations (CFR) by adding a new part 602 for use of financial
assistance awards to support the EH program of epidemiology and other
health-related research. EH health-related financial assistance awards
previously were made under provisions of the generally applicable DOE
Financial Assistance Rules (10 CFR part 600). Part 600 provides basic
DOE procedures for the award and administration of financial
instruments, but does not contain program-specific requirements for
particular types of financial assistance awards. Part 602 builds on and
supplements part 600 by describing the special needs and requirements
of the EH Epidemiologic and Other Health Studies Financial Assistance
Program. Because the rules work together, it is necessary to refer to
both part 600 and this proposal to obtain a comprehensive picture of
program procedures. The rule, in conjunction with part 600, provides a
framework for an ongoing, comprehensive program for the receipt,
review, and evaluation of award applications, and provides specific
guidance for pre- and post-award administration. A discussion of the
major provisions of the rule, organized by rule section, follows.
II. Discussion of Comments on Proposed Rule
DOE issued a proposed rule in the Federal Register on October 18,
1993, [58 FR 53671] to amend existing regulation 10 CFR part 600 to
support EH use of financial assistance awards when they are the
appropriate instruments for programmatic activities. The proposed rule
was to also facilitate a fully open and competitive process for
obtaining financial assistance awards. Comments were requested through
November 17, 1993. DOE received written comments from two university
research administration offices.
One commentator stated that the proposed rules appear reasonable
and expressed willingness to work productively with DOE. The other
commentator expressed concern about EH having a financial assistance
rule separate from other DOE program offices. The correspondent noted
that Federal agencies are now required to eliminate unnecessary
internal management regulations and questioned the need for the
proposed EH rule. The commentator urged DOE to withdraw the proposed
rule and to administer the Epidemiology and Other Health Studies
Financial Assistance Program under the existing Office of Energy
Research Financial Assistance Rule (10 CFR part 605). Noting that the
proposed rule is similar to 10 CFR part 605, the commentator suggested
that EH issue annual program announcements under that existing rule.
DOE has decided not to withdraw the rule for three reasons. First,
DOE needs program-specific financial assistance rules to address unique
mission requirements. Section 602.5, for example, describes specific EH
program areas. Focusing upon the health of the [[Page 5839]] DOE
workforce and related issues, these program areas are distinct from
those of other DOE offices. In light of the Secretary of Energy's
emphasis on protecting worker and community health, DOE must have a
targeted financial assistance mechanism to ensure these areas are
properly supported. Further, section 602.9 commits DOE to use
independent evaluators to ensure credible and inclusive peer review.
This explicit commitment is essential, given the high degree of public
and congressional interest in occupational and environmental health
studies pertaining to DOE.
Second, DOE is currently reviewing its financial assistance rules
under Executive Order 12861. Some of the revisions may eliminate the
need for separate program rules by better accomodating the desire of
assistance programs to address their unique mission in the use of
financial assistance.
Third, the large majority of DOE financial assistance regulations
are already in place at 10 CFR part 600. This means that nearly all the
requirements for audits, patents, financial management, and many other
administrative activities remain unaffected by the EH rule. The EH rule
merely defines a narrow, but significant, range of programmatic needs.
Codification of these needs will help those seeking financial
assistance to understand EH mission requirements and to develop
effective proposals to address these requirements.
III. Final Rule
Section 602.1 defines the purpose and scope of part 602 as setting
policies and procedures for award and administration of EH health
related research, education/training, conferences, and communication
activities through financial assistance awards.
Section 602.2 establishes applicability, stating that part 602
requirements apply to awards made on or after the effective date of the
rule. It also states that part 602 supplements and does not replace 10
CFR part 600.
Section 602.3 defines terms used in the rule. As definitions in 10
CFR part 600 apply to terms in part 602, it was unnecessary to provide
definitions except for a few terms with special meaning for the EH
program of epidemiologic and other health studies.
Section 602.4 governs deviations from the rule. It allows for
single-case deviations from part 602 if authorized by the Assistant
Secretary for EH, the Head of the Contracting Activity, or their
designees. There is no provision for class deviation. If a proposed
single-case deviation from part 602 is also a deviation from 10 CFR
part 600, the provisions for deviations contained in both rules will
apply. Section 602.4 allows for program control over single-case
deviations of a purely program nature, but assures that deviations
relating to generic provisions are also authorized pursuant to the
procedures contained in the generic rules.
Section 602.5 establishes that research, education/training,
conferences, and communication activities in various EH program areas
are eligible for awards under part 602. The program areas are listed in
the section and may be expanded by Federal Register notice.
Section 602.6 sets forth eligibility for awards. The only
categorical restriction pertains to Federal agencies. DOE anticipates
that most recipients will participate through institutions because of
the substantial material and business management resources needed to
conduct projects under the program.
Section 602.7 establishes procedures relating to award
solicitation, including mechanisms to publicize award availability and
distribute application forms and other information. The section also
states that DOE reserves the right to fund, in whole or in part, any,
all, or none of the applications submitted under award solicitations.
Section 602.8 sets forth provisions and procedures required to
apply for an award, including prescribed forms and other information
requirements. Nothing in this section or in 10 CFR part 600 will
prohibit appropriate contacts between potential applicants and DOE
staff prior to submission of applications. Such contacts may include
discussions of broad advice on research areas of interest or
administrative procedures. Requests for information that might provide
an unfair competitive advantage are not permitted.
Section 602.9 describes procedures for application evaluation and
selection. While DOE employees will evaluate the applications and make
award selections, every effort will be made to use reviewers apart from
DOE employees and contractors. Use of outside reviewers will ensure
that the best experts are available to conduct technical evaluations
and will also ensure open and credible peer review of applications.
This is also in keeping with the Federal Government's tradition of
using a broad range of peer reviewers to evaluate the scientific and
technical merit of research proposals.
Section 602.9(d) sets forth the evaluation criteria. They are
necessarily broad because of the wide variety of projects and
approaches anticipated. The criteria are consistent with those used by
other DOE offices and Government agencies in similar programs. Section
602.9(d)(5) will permit DOE to establish, in a notice of availability
or separate solicitation, evaluation criteria consistent with the
purpose of part 602 other than those listed in the rule.
Section 602.9(g) states that selection of applications for award
will be based upon findings of technical evaluations, including peer
reviews. These evaluations will be conducted according to procedures
specified in the EH Merit Review System, which was published as a
Program Notice in the Federal Register on November 25, 1992.
Section 602.10 sets forth certain additional requirements that are
not specifically addressed in 10 CFR part 600. The section requires
recipients performing research involving human subjects, recombinant
DNA molecules (and/or organisms and viruses containing recombinant DNA
molecules) or warm-blooded animals to comply with certain Federal
requirements. While these concerns are not common under DOE-funded
projects, they require special attention because of their importance.
The treatment of these matters is similar to that required by other
Federal agencies.
Section 602.11 provides for a project period that is long and
flexible enough to accommodate research. Measurable results often take
years and cannot be accurately predicted. On the other hand, DOE must
assure adequate programmatic review. Accordingly, initial project
periods of up to 3 years will be the norm. Project periods may exceed 5
years only if DOE makes a renewal award or allows an extension. To
assure adequate financial accountability and review, section 602.11(b)
provides a general budget period of 12 months, which is the norm as
provided under 10 CFR 600.106. To allow for those projects that are not
suited to this limitation, DOE may allow for a budget period of 24
months.
Section 602.12 establishes that cost sharing, while always welcome,
is not a factor in evaluating or selecting applications under the
program. DOE wishes to fund the best projects, not just those of
institutions capable of cost sharing arrangements.
Section 602.13 states that DOE is liable only for the funds noted
in the Notice of Financial Assistance Award. No additional obligations
are required to support or extend a specific award.
Section 602.14 allows fee payment to small business concerns under
[[Page 5840]] appropriate circumstances to permit all qualified parties
to participate in the program. In establishing the need for and the
amount of any such fee, the intrinsic benefits of an award provided to
the recipient, such as advance payments and title to property, will be
taken into consideration.
Section 602.15 establishes that DOE will not provide indirect costs
for conferences and scientific/technical meetings. Conferences and
meetings do not require the institutional infrastructure needed to
support research projects.
Section 602.16 sets forth requirements pertaining to national
security classified information. DOE does not intend this program to
use or develop classified information. If projects develop information
that may be classified, the section provides requirements for its
handling and review. Such projects may be terminated by mutual
agreement.
Since the initial publication of this rule the designated title of
this official has been changed from Director of Classification to
Director of De-classification.
Section 602.17 describes requirements for project continuation
funding and reporting. This section outlines the varieties of reports
required for project accounting and budgeting. A table summarizing the
types of reports, time for submission, and number of copies is set
forth in Appendix A to this part.
Section 602.18 encourages participants to disseminate project
results promptly and will allow DOE to waive technical reporting
requirements if the information is published or accepted for
publication in an appropriate journal.
Section 602.19 establishes requirements for project records and
data. Because DOE is committed to the preservation and sharing of
information with potential value for research or other purposes,
projects are required to implement proper data and records management
procedures. These procedures shall include development and maintenance
of documentation for electronic data. The section also requires award
recipients to comply with designated DOE records and data management
needs, including providing information to the Comprehensive
Epidemiologic Data Resource or to another repository, as DOE directs.
IV. Regulatory Review
Today's regulatory action has been determined not to be a
``significant regulatory action'' under Executive Order 12866,
``Regulatory Planning and Review,'' (58 FR 51735, October 4, 1993).
Accordingly, today's action was not subject to review under the
Executive Order by the Office of Information and Regulatory Affairs.
V. Review Under the Regulatory Flexibility Act
This rule was reviewed under the Regulatory Flexibility Act of 1980
(Pub. L. 96-354, 95 Stat. 1164), which requires preparation of a
regulatory flexibility analysis for any regulation that will have a
significant economic impact on a substantial number of small entities;
i.e., small businesses, small organizations, and small governmental
jurisdictions. DOE concluded that this rule would only affect small
entities as they apply for and receive awards and does not create
additional economic impacts on such entities. Accordingly, DOE
certifies that this rule will not have a significant economic impact on
a substantial number of small entities and, therefore, no regulatory
flexibility analysis has been prepared.
VI. Review Under the Paperwork Reduction Act
OMB has approved information collection requirements under this
rule under control numbers 1910-0400 and 1910-1400.
VII. Review Under the National Environmental Policy Act
DOE has concluded that promulgation of this rule is categorically
excluded under the DOE National Environmental Policy Act (NEPA)
regulations (10 CFR part 1021, appendix A to subpart D) from
preparation of either an Environmental Assessment or an Environmental
Impact Statement under the NEPA of 1969 (42 U.S.C. 4321, et. seq.
[1976]) as a rulemaking establishing application and review procedures
for grants and cooperative agreements.
VIII. Intergovernmental Review
This program is generally not subject to the intergovernmental
review requirements of Executive Order 12372, as implemented by 10 CFR
part 1005. However, certain applications for financial assistance
awards may require this review. Such applications, including those from
governmental or nongovernmental entities that involve research,
development, or demonstration activities, are subject to the provisions
of the Executive Order and 10 CFR part 1005 when such activities: (1)
have a unique geographic focus and are directly relevant to the
governmental responsibilities of a State or local government within the
geographic area; (2) necessitate preparation of an Environmental Impact
Statement under NEPA; or (3) are to be initiated at a particular site
or location and require unusual measures to limit the possibility of
adverse exposure or hazard to the general public. Entities planning to
submit such applications should contact the Office of Epidemiology and
Health Surveillance (EH-42), U.S. Department of Energy, Washington, DC
20585 for further information.
IX. Review Under Executive Order 12612
Executive Order 12612 requires review of regulations or rules for
any substantial direct effects on States, on the relationship between
National Government and the States, or on the distribution of power and
responsibilities among various levels of Government. This rule amends,
by addition of a new part, existing regulations for a financial
assistance program to stimulate research and development. There will
not be any substantial direct effects on States.
X. Review Under Executive Order 12778
Section 2 of Executive Order 12778 instructs each agency to adhere
to certain requirements in promulgating new regulations and reviewing
existing regulations. These requirements, set forth in sections 2(a)
and (b)(2), include eliminating drafting errors and needless ambiguity,
drafting the regulations to minimize litigation, providing clear and
certain legal standards for affected conduct, and promoting
simplification and burden reduction. Agencies are also instructed to
make every reasonable effort to ensure that the regulation: specifies
clearly any preemptive effect, effect on existing Federal law or
regulation, and retroactive effect; describes any administrative
proceedings to be available prior to judicial review and any provisions
for the exhaustion of such administrative proceedings; and defines key
terms. DOE certifies that today's proposal meets the requirements of
sections 2(a) and (b) of Executive Order 12778.
XI. Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance number for Epidemiology
and Other Health Studies Financial Assistance Program is 81.108.
List of Subjects in 10 CFR Part 602
Energy, Grant programs--health, Health, Medical research,
Occupational safety and health, Reporting and recordkeeping
requirements, Research.
For the reasons set forth in the preamble, chapter II of title 10
CFR is [[Page 5841]] amended by adding a new part 602, as set forth
below.
Issued in Washington, DC, on January 18, 1995.
Tara O'Toole,
Assistant Secretary Environment, Safety and Health.
Chapter II of title 10 CFR is amended by adding part 602 to read as
follows:
PART 602--EPIDEMIOLOGY AND OTHER HEALTH STUDIES FINANCIAL
ASSISTANCE PROGRAM
Sec.
602.1 Purpose and scope.
602.2 Applicability.
602.3 Definitions.
602.4 Deviations.
602.5 Epidemiology and Other Health Studies Financial Assistance
Program.
602.6 Eligibility.
602.7 Solicitation.
602.8 Application requirements.
602.9 Application evaluation and selection.
602.10 Additional requirements.
602.11 Funding.
602.12 Cost sharing.
602.13 Limitation of DOE liability.
602.14 Fee.
602.15 Indirect cost limitations.
602.16 National security.
602.17 Continuation funding and reporting requirements.
602.18 Dissemination of results.
602.19 Records and data.
Appendix A to Part 602--Schedule of Renewal Applications and Reports
Authority: 42 U.S.C. 2051; 42 U.S.C. 5817; 42 U.S.C. 5901-5920;
42 U.S.C. 7254 and 7256; 31 U.S.C. 6301-6308.
Sec. 602.1 Purpose and scope.
This part sets forth the policies and procedures applicable to the
award and administration of grants and cooperative agreements by DOE
(through the Office of Environment, Safety and Health or any office to
which its functions are subsequently redelegated) for health related
research, education/training, conferences, communication, and related
activities.
Sec. 602.2 Applicability.
(a) This part applies to all grants and cooperative agreements
awarded after the effective date of this rule.
(b) Except as otherwise provided by this part, the award and
administration of grants and cooperative agreements shall be governed
by 10 CFR part 600 (DOE Financial Assistance Rules).
Sec. 602.3 Definitions.
In addition to the definitions provided in 10 CFR part 600, the
following definitions are provided for purposes of this part:
Conference and communication activities means scientific or
technical conferences, symposia, workshops, seminars, public meetings,
publications, video or slide shows, and other presentations for the
purpose of communicating or exchanging information or views pertinent
to DOE.
DOE means the United States Department of Energy.
Education/Training means support for education or related
activities for an individual or organization that will enhance
educational levels and skills, in particular, scientific or technical
areas of interest to DOE.
Epidemiology and Other Health Studies means research pertaining to
potential health effects resulting from DOE or predecessor agency
operations or from any aspect of energy production, transmission, or
use (including electromagnetic fields) in the United States and abroad.
Related systems or activities to enhance these areas, as well as other
program areas that may be described by notice published in the Federal
Register, are also included.
Principal investigator means the scientist or other individual
designated by the recipient to direct the project.
Research means basic and applied research and that part of
development not related to the development of specific systems or
products. The primary aim of research is scientific study and
experimentation directed toward advancing the state of the art or
increasing knowledge or understanding rather than focusing on a
specific system or product.
Sec. 602.4 Deviations.
(a) Single-case deviations from this part may be authorized in
writing by the Assistant Secretary for Environment, Safety and Health,
the Head of the Contracting Activity, or their designees, upon the
written request of DOE staff, an applicant for award, or a recipient. A
request from an applicant or a recipient must be submitted to or
through the cognizant contracting officer.
(b) Whenever a proposed deviation from this part would be a
deviation from 10 CFR part 600, the deviation must also be authorized
in accordance with the procedures prescribed in that part.
Sec. 602.5 Epidemiology and Other Health Studies Financial Assistance
Program.
(a) DOE may issue under this part awards for research, education/
training, conferences, communication, and related activities in the
Office of Environment, Safety and Health program areas set forth in
paragraph (b) of this section.
(b) The program areas are:
(1) Health experience of DOE and DOE contractor workers;
(2) Health experience of populations living near DOE facilities;
(3) Workers exposed to toxic substances, such as beryllium;
(4) Use of biomarkers to recognize exposure to toxic substances;
(5) Epidemiology and other health studies relating to energy
production, transmission, and use (including electromagnetic fields) in
the United States and abroad;
(6) Compilation, documentation, management, use, and analysis of
data for the DOE Comprehensive Epidemiologic Data Resource; and
(7) Other systems or activities enhancing these areas, as well as
other program areas as may be described by notice published in the
Federal Register.
Sec. 602.6 Eligibility.
Any individual or entity other than a Federal agency is eligible
for a grant or cooperative agreement. An unaffiliated individual is
also eligible for a grant or cooperative agreement.
Sec. 602.7 Solicitation.
(a) The Catalog of Federal Domestic Assistance number for 10 CFR
part 602 is 81.108 and its solicitation control number is EOHSFAP 10
CFR part 602.
(b) An application for a new or renewal award under this
solicitation may be submitted at any time to DOE at the address
specified in paragraph (c) of this section. New or renewal applications
shall receive consideration for funding generally within 6 months but,
in any event, no later than 12 months from the date of receipt by DOE.
(c) Except as otherwise provided in a notice of availability,
applicants may obtain application forms, described in 602.8(b) of this
part, and additional information from the Office of Epidemiology and
Health Surveillance (EH-42), U.S. Department of Energy, Washington, DC
20585, (301) 903-5926, and shall submit applications to the same
address.
(d) DOE will publish program notices in the Federal Register
regarding the availability of epidemiology and other health studies
financial assistance. DOE may also use other means of communication, as
appropriate, such as the publication of notices of availability in
trade and professional journals and news media.
(1) Each notice of availability shall cite this part and shall
include:
(i) The Catalog of Federal Domestic Assistance number and
solicitation control number of the program;
(ii) The amount of money available or estimated to be available for
award;
(iii) The name of the responsible DOE program official to contact
for additional [[Page 5842]] information and an address where
application forms may be obtained;
(iv) The address for submission of applications; and
(v) Any evaluation criteria in addition to those set forth in
Sec. 602.9 of this part.
(2) The notice of availability may also include any other relevant
information helpful to applicants such as:
(i) Program objectives;
(ii) A project agenda or potential area of project initiatives;
(iii) Problem areas requiring additional effort; and
(iv) Any other information that identifies areas in which grants or
cooperative agreements may be made.
(e) DOE is under no obligation to pay for any costs associated with
the preparation or submission of applications.
(f) DOE reserves the right to fund, in whole or in part, any, all,
or none of the applications submitted.
(g) To be considered for a renewal award under this part, an
incumbent recipient shall submit a continuation or renewal application,
as provided in Sec. 602.8 (c) and (h) of this part.
Sec. 602.8 Application requirements.
(a) An original and seven copies of the application for initial
support must be submitted, except that State and local governments and
Indian tribal governments shall not be required to submit more than the
original and two copies of the application.
(b) Each new or renewal application in response to this part must
include:
(1) An application face page, DOE Form 4650.2 (approved by OMB
under OMB Control No. 1910-1400). However, the face page of an
application submitted by a State or local government or an Indian
tribal government shall be the face page of Standard Form 424 (approved
by OMB under OMB Control Number 0348-0043).
(2) A detailed description of the proposed project, including its
objectives, its relationship to DOE's program, its impact on the
environment, if any, and the applicant's plan for carrying it out.
(3) Detailed information about the background and experience of the
recipients of funds or, as appropriate, the principal investigator(s)
(including references to publications), the facilities and experience
of the applicant, and the cost-sharing arrangements, if any.
(4) A detailed budget for the entire proposed period of support
with written justification sufficient to evaluate the itemized list of
costs provided on the entire project. Applicants should note the
following when preparing budgets:
(i) Numerical details on items of cost provided by State and local
government and Indian tribal government applicants shall be on Standard
Form 424A, ``Budget Information for Non-Construction Programs''
(approved under OMB Control No. 0348-0044). All other applicants shall
use budget forms ERF 4620.1 (approved by OMB under Control No. 1910-
1400).
(ii) DOE may, subsequent to receipt of an application, request
additional budgetary information from an applicant when necessary for
clarification or make informed pre-award determinations under 10 CFR
part 600.
(5) Any pre-award assurances required pursuant to 10 CFR parts 600
and 602.
(c) Applications for a renewal award must be submitted with an
original and seven copies, except that State and local governments and
Indian tribal government applicants are required to submit only an
original and two copies (Approved by OMB under OMB Control Numbers
0348-00050348-0009.)
(d) The application must be signed by an official who is authorized
to act for the applicant organization and to commit the applicant to
comply with the terms and conditions of the award, if one is issued, or
if unaffiliated, by the individual applicant. (See Sec. 602.17(a)(1)
for requirements on continuation awards.)
(e) DOE may return an application that does not include all
information and documentation required by statute, this part, 10 CFR
part 600, or the notice of availability, when the nature of the
omission precludes review of the application.
(f) During the review of a complete application, DOE may request
the submission of additional information only if the information is
essential to evaluate the application.
(g) In addition to including the information described in
paragraphs (b), (c), and (d) of this section, an application for a
renewal award must be submitted no later than 6 months before the
expiration of the project period and must be on the same forms as
required for initial applications. The renewal application must outline
and justify a program and budget for the proposed project period,
showing in detail the estimated cost of the proposed project, together
with an indication of the amount of cost sharing, if any. The
application shall also describe and explain the reasons for any change
in the scope or objectives of the proposed project and shall compare
and explain any difference between the estimates in the proposed budget
and actual costs experienced as of the date of the application.
(h) DOE is not required to return an application to the applicant.
(i) Renewal applications must include a separate section that
describes the results of work accomplished through the date of the
renewal application and how such results relate to the activities
proposed to be undertaken in the renewal period.
Sec. 602.9 Application evaluation and selection.
(a) Applications shall be evaluated for funding generally within 6
months, but in any event no later than 12 months, from the date of
receipt by DOE. After DOE has held an application for 6 months, the
applicant may, in response to DOE's request, be required to revalidate
the terms of the original application.
(b) DOE shall perform an initial evaluation of all applications to
ensure that the information required by this part is provided, that the
proposed effort is technically sound and feasible, and that the effort
is consistent with program funding priorities. For applications that
pass the initial evaluation, DOE shall review and evaluate each
application received based on the criteria set forth below and in
accordance with the Office of Environment, Safety and Health Merit
Review System developed, as required, under DOE Financial Assistance
Regulations, 10 CFR part 600.
(c) DOE shall select evaluators on the basis of their professional
qualifications and expertise. To ensure credible and inclusive peer
review of applications, every effort will be made to select evaluators
apart from DOE employees and contractors. Evaluators shall be required
to comply with all applicable DOE rules or directives concerning the
use of outside evaluators.
(d) DOE shall evaluate new and renewal applications based on the
following criteria that are listed in descending order of importance:
(1) The scientific and technical merit of the proposed research;
(2) The appropriateness of the proposed method or approach;
(3) Competency of research personnel and adequacy of proposed
resources;
(4) Reasonableness and appropriateness of the proposed budget; and
(5) Other appropriate factors consistent with the purpose of this
part established and set forth in a Notice of Availability or in a
specific solicitation.
(e) DOE shall also consider as part of the evaluation other
available advice or information, as well as program policy
[[Page 5843]] factors, such as ensuring an appropriate balance among
the program areas listed in Sec. 602.5 of this part.
(f) In addition to the evaluation criteria set forth in paragraphs
(d) and (e) of this section, DOE shall consider the recipient's
performance under the existing award during the evaluation of a renewal
application.
(g) Selection of applications for award will be based upon the
findings of the technical evaluations (including peer reviews, as
specified in the Office of Environment, Safety and Health Merit Review
System), the importance and relevance of the proposal to the Office of
Environment, Safety and Health's mission, and the availability of
funds. Cost reasonableness and realism will also be considered.
(h) After the selection of an application, DOE may, if necessary,
enter into negotiations with an applicant. Such negotiations are not a
commitment that DOE will make an award.
Sec. 602.10 Additional requirements.
(a) A recipient performing research or related activities involving
the use of human subjects must comply with DOE regulations in 10 CFR
part 745, ``Protection of Human Subjects,'' and any additional
provisions that may be included in the special terms and conditions of
an award.
(b) A recipient 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'' (51 FR
16958, May 7, 1986), or such later revision of those guidelines, as may
be published in the Federal Register. (The guidelines are available
from the Office of Recombinant DNA Activities, National Institutes of
Health, Building 31, Room BBB, Bethesda, MD 20892, or from the Office
of Epidemiology and Health Surveillance, (EH-42), U.S. Department of
Energy, Washington, DC 20585).
(c) A recipient performing research on warm-blooded animals shall
comply with the Federal Laboratory Animal Welfare Act of 1966, as
amended (7 USC 2131 et seq.), and the regulations promulgated
thereunder by the Secretary of Agriculture at 9 CFR chapter I,
subchapter A, pertaining to the care, handling, and treatment of warm-
blooded animals held or used for research, teaching, or other
activities supported by Federal awards. The recipient shall comply with
the guidelines described in the Department of Health and Human Services
Publication No. [NIH] 86-23, ``Guide for the Care and Use of Laboratory
Animals,'' or succeeding revised editions. (This guide is available
from the Office for Protection from Research Risks, Office of the
Director, National Institutes of Health, Building 31, Room 4B09,
Bethesda, MD 20892, or from the Office of Epidemiology and Health
Surveillance, (EH-42), U.S. Department of Energy, Washington, DC
20585).
Sec. 602.11 Funding.
(a) The project period during which DOE expects to provide support
for an approved project under this part shall generally not exceed 3
years and may exceed 5 years only if DOE makes a renewal award or
otherwise extends the award. The project period shall be specified on
the Notice of Financial Assistance Grant (DOE Form 4600.1).
(b) Each budget period of an award under this part shall generally
be 12 months and may be as much as 24 months, as DOE deems appropriate.
Sec. 602.12 Cost sharing.
Cost sharing is not required, nor will it be considered, as a
criterion in the evaluation and selection process unless otherwise
provided under Sec. 602.9(d)(5).
Sec. 602.13 Limitation of DOE liability.
Awards made under this part are subject to the requirement that the
maximum DOE obligation to the recipient is the amount shown in the
Notice of Financial Assistance Award as the amount of DOE funds
obligated. DOE shall not be obligated to make any additional,
supplemental, continuation, renewal, or other award for the same or any
other purpose.
Sec. 602.14 Fee.
(a) Notwithstanding 10 CFR part 600, a fee may be paid, in
appropriate circumstances, to a recipient that is a small business
concern, as qualified under the criteria and size standards of 13 CFR
part 121, in order to permit the concern to participate in the
Epidemiology and Other Health Studies Financial Assistance Program.
Whether or not it is appropriate to pay a fee shall be determined by
the contracting officer, who shall, at a minimum, apply the following
guidelines:
(1) Whether the acceptance of an award will displace other work
that the small business is currently engaged in or committed to assume
in the near future; or
(2) Whether the acceptance of an award will, in the absence of
paying a fee, cause substantial financial distress to the business. In
evaluating financial distress, the contracting officer shall balance
current displacement against reasonable future benefit to the company.
(If the award will result in the beneficial expansion of the existing
business base of the company, then no fee would generally be
appropriate.) Fees shall not be paid to other entities except as a
deviation from 10 CFR part 600, nor shall fees be paid under awards in
support of conferences.
(b) To request a fee, a small business concern shall submit with
its application a written self-certification that it is a small
business concern qualified under the criteria and size standards in 13
CFR part 121. In addition, the application must state the amount of fee
requested for the entire project period and the basis for requesting
the amount and must also state why payment of a fee by DOE would be
appropriate.
(c) If the contracting officer determines that payment of a fee is
appropriate under paragraph (a) of this section, the amount of fee
shall be that determined to be reasonable by the contracting officer.
The contracting officer shall, at a minimum, apply the following
guidelines in determining the fee amount:
(1) The fee base shall include the estimated allowable cost of
direct salaries and wages and allocable fringe benefits. This fee base
shall exclude all other direct and indirect costs.
(2) The fee amount expressed as a percentage of the appropriate fee
base, pursuant to paragraph (c)(1) of this section, shall not exceed
the percentage rate of fee that would result if a Federal agency
contracted for the same amount of salaries, wages, and allocable fringe
benefits under a cost reimbursement contract.
(3) Fee amounts, determined pursuant to paragraphs (c)(1) and
(c)(2) of this section, shall be appropriately reduced when:
(i) Advance payments are provided; and/or
(ii) Title to property acquired with DOE funds vests in the
recipient (10 CFR part 600).
(d) Notwithstanding 10 CFR part 600, any fee awarded shall be a
fixed fee and shall be payable on an annual basis in proportion to the
work completed, as determined by the contracting officer, upon
satisfactory submission and acceptance by DOE of the progress report.
If the project period is shortened due to termination, or the project
period is not fully funded, the fee shall be reduced by an appropriate
amount.
Sec. 602.15 Indirect cost limitations.
Awards issued under this part for conferences and scientific/
technical [[Page 5844]] meetings will not include payment for indirect
costs.
Sec. 602.16 National security.
Activities under the Epidemiology and Other Health Studies
Financial Assistance Program are not expected to involve classified
information (i.e., Restricted Data, Formerly Restricted Data, National
Security Information). However, if in the opinion of the recipient or
DOE such involvement becomes expected prior to the closeout of the
award, the recipient or DOE shall notify the other in writing
immediately. If the recipient believes any information developed or
acquired may be classified, the recipient shall not provide the
potentially classified information to anyone, including DOE officials
with whom the recipient normally communicates, except the Director of
Declassification, and shall protect such information as if it were
classified until notified by DOE that a determination has been made
that it does not require such handling. Correspondence that includes
the specific information in question shall be sent by registered mail
to the U.S. Department of Energy, Attn: Director of Declassification,
NN-50, Washington, DC 20585. If the information is determined to be
classified, the recipient may wish to discontinue the project, in which
case the recipient and DOE shall terminate the award by mutual
agreement. If the award is to be terminated, all material deemed by DOE
to be classified shall be forwarded to DOE in a manner specified by DOE
for proper disposition. If the recipient and DOE wish to continue the
award, even though classified information is involved, the recipient
shall be requested to obtain both personnel and facility security
clearances through the Office of Safeguards and Security for
Headquarters awards or from the cognizant field office Division of
Safeguards and Security for awards obtained through DOE field
organizations. Costs associated with handling and protecting any such
classified information shall be negotiated at the time that the
determination to proceed is made.
Sec. 602.17 Continuation funding and reporting requirements.
(a) A recipient shall periodically report to DOE on the project's
progress in meeting the project objectives of the award. The following
types of reports shall be used:
(1) Progress Reports. After issuance of an initial award,
recipients must submit a satisfactory progress report to receive a
continuation award for the remainder of the project period. The
original and two copies of the required report must be submitted to the
Office of Environment, Safety and Health program manager 90 days prior
to the anticipated continuation funding date. The report should include
results of work to date and emphasize findings and their significance
to the field, and any real or anticipated problems. The report also
should contain the following information: On the first page, provide
the project title, principal investigator/project director name, period
of time the report covers, name and address of recipient organization,
DOE award number, the amount of unexpended funds, if any, that are
anticipated to be left at the end of the current budget period. If the
amount exceeds 10 percent of the funds available for the budget period,
provide information as to why the excess funds are anticipated to be
available and how they will be used in the next budget period. The
report should state whether the aims have changed from the original
application, and if they have, provide revised aims. A completed budget
page must be submitted with the continuation progress report when a
change to anticipated future costs will exceed 25 percent of the
original recommended future budget.
(2) Notice of Energy Research and Development (R&D) Project. A
Notice of Energy R&D Project, DOE Form 1430.22, which summarizes the
purpose and scope of the project, must be submitted in accordance with
the Distribution and Schedule of Documents set forth in Appendix A to
this part, Schedule of Renewal Applications and Reports. Copies of the
form may be obtained from a DOE contracting office.
(3) Special Reports. The recipient shall report the following
events to DOE as soon after they occur as possible:
(i) Problems, delays, or adverse conditions that will materially
affect the ability to attain project objectives or prevent the meeting
of time schedules and goals. The report must describe remedial action
that the recipient has taken, or plans to take, and any action DOE
should take to alleviate the problems.
(ii) Favorable developments or events that enable meeting time
schedules and goals sooner, or a lower cost than anticipated, or
producing more beneficial results than originally projected.
(4) Final Report. A final report covering the entire project must
be submitted by the recipient within 90 days after the project period
ends or the award is terminated. Satisfactory completion of an award
will be contingent upon the receipt of this report. The final report
shall follow the same outline as progress reports. Recipients will
provide, as part of the final report, a description of records and data
compiled during the project, along with a plan for its preservation or
disposition (see Sec. 602.19 of this part). All manuscripts prepared
for publication should be appended to the final report.
(5) Financial Status Report (FSR) (OMB No. 0348-0039). The FSR is
required within 90 days after completion of each budget period. For
budget periods exceeding 12 months, an FSR is also required within 90
days after this first 12 months unless waived by the contracting
officer.
(b) DOE may extend the deadline date for any report if the
recipient submits a written request before the deadline, that
adequately justifies an extension.
(c) A table summarizing the various types of reports, time for
submission, and number of copies is set forth in appendix A to this
part. The schedule of reports shall be as prescribed in this table,
unless the award document specifies otherwise. These reports shall be
submitted by the recipient to the awarding office.
(d) DOE, or its authorized representatives, may make site visits,
at any reasonable time, to review the project. DOE may provide such
technical assistance as may be requested.
(e) Recipients may place performance reporting requirements on a
subrecipient consistent with the provisions of this section.
Sec. 602.18 Dissemination of results.
(a) Recipients are encouraged to disseminate research results
promptly. DOE reserves the right to utilize, and have others utilize to
the extent it deems appropriate, the reports resulting from research
awards.
(b) DOE may waive the technical reporting requirement of progress
reports set forth in Sec. 602.17, if the recipient submits to DOE a
copy of its own report that is published or accepted for publication in
a recognized scientific or technical journal and that satisfies the
information requirements of the program.
(c) Recipients are urged to publish results through normal
publication channels in accordance with the applicable provisions of 10
CFR part 600.
(d) The article shall include an acknowledgement that the project
was supported, in whole or in part, by a DOE award, and specify the
award number, but state that such support does not
[[Page 5845]] constitute an endorsement by DOE of the views expressed
in the article.
Sec. 602.19 Records and Data
(a) In some cases, DOE will require submission of certain project
records or data to facilitate mission-related activities. Recipients,
therefore, must take adequate steps to ensure proper management,
control, and preservation of all project records and data.
(b) Awardees must ensure that all project data is adequately
documented. Documentation shall:
(1) Reference software used to compile, manage, and analyze data;
(2) Define all technical characteristics necessary for reading or
processing the records;
(3) Define file and record content and codes;
(4) Describe update cycles or conditions and rules for adding or
deleting information; and
(5) Detail instrument calibration effects, sampling and analysis,
space and time coverage, quality control measures, data algorithms and
reduction methods, and other activities relevant to data collection and
assembly.
(c) Recipients agree to comply with designated DOE records and data
management requirements, including providing electronic data in
prescribed formats and retention of specified records and data for
eventual transfer to the Comprehensive Epidemiologic Data Resource or
to another repository, as directed by DOE. Recipients will provide, as
part of the final report, a description of records and data compiled
during the project along with a plan for its preservation or
disposition.
(d) Recipients agree to make project records and data available as
soon as possible when requested by DOE.
Appendix A to Part 602.--Schedule of Renewal Applications and Reports
------------------------------------------------------------------------
Number of
copies
Type When due for
awarding
office
------------------------------------------------------------------------
1. Summary: 200 words on scope Immediately after a grant is 3
and purpose (Notice of Energy awarded and with each
R&D Project). application for renewal.
2. Renewal period ends........ 6 months before the budget... 8
3. Progress Report period (or 90 days prior to the next 3
as part of a renewal budget period.
application).
4. Other progress reports, As deemed appropriate by DOE 3
brief topical reports, etc. or the recipient.
(Designated when significant
results develop or when work
has direct programmatic
impact).
5. Reprints, Conference....... Same as 4. above............. 3
6. Final report of the project Within 90 days after 3
completion.
7. Financial Status Report Within 90 days after 3
(FSR). completion of the project
period; for budget periods
exceeding 12 months an FSR
is also required within 90
days after the first 12-
month period.
------------------------------------------------------------------------
Note: Report types 5 and 6 require with submission two copies of DOE
Form 1332.16, University-Type Contractor and Grantee Recommendations
for Disposition of Scientific and Technical Document.
[FR Doc. 95-2344 Filed 1-30-95; 8:45 am]
BILLING CODE 6450-01-P
