[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