[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Notices]
[Pages 33059-33063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15960]


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DEPARTMENT OF ENERGY


Office of Environment, Safety and Health; Notice of Availability 
of Funds and Request for Applications for Radiation Health Effects 
Studies in the Russian Federation

AGENCY: Office of Environment, Safety and Health, DOE.

ACTION: Notice of availability of funds and request for applications.

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SUMMARY: The Office of International Health Programs, Office of Health 
Studies, U.S. Department of Energy (DOE), announces that it is 
accepting applications for cooperative agreements to support 
population-based studies on low dose-rate radiation health effects in 
the Russian Federation. This Notice is issued subsequent to the more 
general Continuation of Solicitation for Epidemiology and Other Health 
Studies Financial Assistance Program published in the Federal Register 
(61 FR 53903) on October 16, 1996.

DATES: The deadline for receipt of formal applications is September 16, 
1997.

ADDRESSES: U.S. Department of Energy, Office of International Health 
Programs, EH-63/270CC, 19901 Germantown Road, Germantown, Maryland 
20874-1290

FOR FURTHER INFORMATION CONTACT: Requests for further information and 
application forms may be directed to Dr. Ruth Neta, Office of 
International Health Programs (EH-63), U.S. Department of Energy, 
telephone: (301) 903-1757; facsimile: (301) 903-1413. Applications may 
be submitted to Dr. Neta at the above address.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Purpose
II. Background
III. Project Description
IV. Applications
V. DOE's Policy on Protection of Human Subjects Reviews
VI. Applicants
VII. DOE's Role

I. Purpose

    The Office of International Health Programs funds, in partnership 
with the Russian Federation, epidemiologic studies of cohorts of 
workers and populations to evaluate the health consequences (cancer and 
other diseases) of exposure to low-dose rate ionizing radiation. These 
ongoing studies are coordinated through the Joint Coordinating 
Committee for Radiation Effects Research (JCCRER). Section II 
(``Background'') below

[[Page 33060]]

provides a description of the JCCRER and Section III (``Project 
Description'') sets forth a description of the populations currently 
being studied in the Russian Federation under research funded by DOE 
and other U.S. agencies.
    Relatively few U.S. scientists and institutions have collaborative 
relationships with scientists and institutions in the Russian 
Federation for radiation health effects studies. These relationships 
have taken years to establish and are generally limited to traditional 
epidemiologic studies of health effects. One purpose of this Notice is 
to encourage U.S. scientists and institutions, who are on the cutting 
edge of molecular biology and other newly developing approaches and 
technologies, but who may not have an established record in radiation 
health effects research or collaborative relationships with Russian 
scientists, to apply these newly developed approaches and technologies 
to health effects studies in the Russian Federation.
    The following are examples of areas where newly developed 
technology and new research approaches may be applied to ongoing 
radiation health effects studies:
     Molecular epidemiology;
     Biomarkers and biodosimetry;
     Biological tissue (including blood) sample banks; and
     Epidemiology.
    For example, molecular epidemiology studies could look for 
potential molecular changes associated with low dose-rate, radiation-
induced carcinogenesis and other radiation-induced diseases (if they 
exist) in the MAYAK cohorts described below in Section III.A.2. 
(``MAYAK Workers Cohort''). Such new research holds promise for 
identifying the molecular mechanisms and processes of radiogenic cancer 
and other diseases. In addition, DOE is interested in identifying 
biological markers of low dose-rate radiation exposures (biomarkers and 
biodosimetry) and in projects that will provide a framework for 
preserving biological samples and necessary records for future studies.
    The other purpose of this Notice is to encourage research that 
builds upon epidemiologic work conducted by the JCCRER that is already 
underway (e.g., MAYAK cohorts), or that applies to epidemiologic 
studies in the Russian Federation not currently coordinated by the 
JCCRER (i.e., studies in the Russian Federation in which DOE is not 
involved) but where epidemiologic and dosimetry data are available. 
Here, cost and other economies can be realized because the 
epidemiologic databases are already available. Augmenting ongoing 
studies coordinated by the JCCRER or other epidemiologic studies in the 
Russian Federation therefore will be a program policy factor considered 
in the selection process. (See Section IV.B. ``Evaluation and 
Selection'' below.)
    Information from these augmented studies is expected to be of major 
importance to DOE's mission to protect U.S. workers and populations 
from risks of exposures that may be associated with the Department's 
current and future activities. Studies funded under this Notice will be 
conducted jointly with scientists from the Russian Federation.

II. Background

    The JCCRER is a bilateral government committee representing 
agencies from the United States and the Russian Federation established 
to implement the Agreement on Cooperation in Research on Radiation 
Effects for the Purpose of Minimizing the Consequences of Radioactive 
Contamination on Health and the Environment signed on January 1, 1994, 
by U.S. Secretary of State Warren Christopher and Russian Foreign 
Minister Andrey Kozyrev to support and facilitate joint cooperative 
research.
    Radiation research conducted jointly with the Russian Federation 
provides a unique opportunity to learn more about possible risks to 
groups of people from lengthy exposure to radiation. This could include 
people receiving exposure from uranium mining, operations of nuclear 
facilities, transport and disposal of radioactive materials, the 
testing and dismantling of nuclear weapons, radiation accidents, and 
grossly contaminated sites or facilities.
    Currently, the JCCRER and DOE are focusing on population and worker 
studies in the Southern Urals region of the Russian Federation. In 
1948, a nuclear weapons production complex, ``MAYAK,'' was established 
by the Soviet Union in Southern Urals, about 100 km northeast of the 
city of Chelyabinsk. Large amounts of radioactive materials were 
released into the environment between 1948 and 1957. Liquid discharges 
into the Techa River from the MAYAK operational facility occurred from 
1949-1956. As a result, thousands of square kilometers have been 
contaminated and hundreds of thousands of people have received 
significant radiation exposures. Furthermore, because of limited and 
inadequate (by today's standards) radiation protection measures and 
procedures, thousands of MAYAK workers and the population along the 
Techa River were seriously overexposed to radiation.
    The studies of Southern Ural's populations may provide an 
opportunity to answer the question of whether chronic low-level 
exposures pose a risk different from that previously assumed. Most of 
DOE's knowledge of health effects and risks associated with radiation 
exposures is based on studies of atomic bomb survivors in Japan and 
patients treated with radiation therapy. These individuals, however, 
were exposed to very short bursts of external radiation, unlike the 
pattern of exposure normally encountered or expected in the nuclear 
industry and with other uses of radiation. The Southern Urals' 
populations experienced chronic exposures over a much longer period. 
The exposures were also from both external radiation and internally 
deposited radioactive compounds. Definitive studies on the Southern 
Urals populations, coupled with comparisons with U.S. nuclear worker 
data, may prove to be a key factor in future development of radiation 
protection standards and regulations in the United States and 
worldwide. Thus, the preservation, restoration and analysis of 
radiation exposure, medical and environmental data in the Southern 
Urals are extremely important to the United States and to the world.
    The current U.S. JCCRER members are the:
     U.S. Department of Energy (DOE);
     U.S. Nuclear Regulatory Commission (NRC);
     U.S. Department of Health and Human Services (HHS);
     U.S. Centers for Disease Control and Prevention (CDC);
     U.S. Department of Defense (DoD);
     U.S. National Aeronautics and Space Administration (NASA); 
and
     U.S. Environmental Protection Agency (EPA).
    The current Russian JCCRER members are the:
     Ministry for Civil Defense Affairs, Emergencies and 
Elimination of Consequences of Natural Disasters (EMERCOM);
     Ministry of Atomic Energy (MINATOM); and
     Ministry of Health (MINZDRAV).
    The Russian institutions currently participating in JCCRER-
coordinated studies are the:
     Nuclear Safety Institute (IBRAE) of Russian Academy of 
Sciences, Moscow;
     Branch #1 of Moscow Biophysics Institute (FIB-1), Ozersk;
     ``MAYAK'' Scientific and Production Association, Ozersk;
     Urals Research Center for Radiation Medicine (URCRM), 
Chelyabinsk;

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     Institute of Marine Transport Hygiene, St. Petersburg; and
     Institute of Metal Physics, Ekaterinburg.

III. Project Description

A. Description of Cohorts

    Two different epidemiologic research directions currently are 
supported by the JCCRER: studies of populations who live near the Techa 
River and studies of workers at the MAYAK facility.
1. Techa River Population Cohort
    The liquid discharges to the Techa River from the MAYAK operational 
facility (due to inadequate storage of radioactive waste) occurred from 
1949-56, with 95 percent released in an 18-month period (March 1950 to 
November 1951), for a total release of about 3 million Ci.
    The cohort registry consists of individuals born in 1949 or 
earlier, who lived for at least one (1) month during 1950 to 1952 in 
the villages along the Techa River. The cohort includes 28,000 
individuals, about 20 percent of which have been estimated to have had 
average effective doses of exposure of more than 0.5 sievert (Sv). 
Thirty percent of the cohort members were 0 to 14 years old at the time 
of exposure.
    The external exposure was due from contaminated sediments in the 
river; the internal exposure (measured by whole body counts and 
conducted for half of the members of the cohort) was mainly due to 
intake of river water and milk and included Sr 89, 90, and Cs 137.
    Published reports indicate a statistically significant increase in 
leukemia in the exposed versus control populations. Other cancers, 
including stomach, esophagus, and lung were also studied, but the 
results have not been conclusive.
2. MAYAK Workers Cohort
    The computerized registry of 19,000 MAYAK workers contains: 
occupational histories, vital status, current place of residence or 
date and causes of death, annual and cumulative data doses, plutonium 
body burdens, and internal doses to the main organs (lungs, liver and 
bone marrow). In this cohort, 14,000 have known vital status; 4,000 are 
dead; 1,000 died of cancer; and more than 4,000 have known plutonium 
body burdens. The average value of the equivalent dose to the lung for 
all workers with measured plutonium (Pu 239) body burden of 7.06 Sv, 
with external gamma doses of 0.88 gray (Gy) for all workers included in 
the registry. Radiation doses decreased significantly with time, for 
example:

------------------------------------------------------------------------
              Years hired                       Average  exposure       
------------------------------------------------------------------------
1948-53................................  1.57 Gy.                       
1954-58................................  0.57 Gy.                       
1959-63................................  0.27 Gy.                       
1964-72................................  0.15 Gy.                       
------------------------------------------------------------------------

    More than 1,800 occupational diseases were diagnosed by 1959, 92 
percent of which were noted between 1949 and 1953. Eighty-three percent 
of these were diagnosed as ``chronic radiation sickness'' caused by 
radiation exposures of 1 to 10 Gy. Forty-one cases were diagnosed as 
``acute radiation syndrome,'' four of which were fatal. Burns and other 
local radiation injury were reported for 188 workers. In addition, 110 
cases of pnemosclerosis (66 in individuals whose internal lung exposure 
exceeded 4.0 Gy) were diagnosed.

B. JCCRER Directions

    The JCCRER has initiated projects to study the Techa and MAYAK 
cohorts called Directions. Direction 1 studies the Techa population and 
Direction 2 studies the MAYAK workers. These projects are jointly 
conducted by both U.S. and Russian principal investigators and their 
respective teams of researchers, and are summarized below.
Direction 1: ``Medical Aspects of Radiation Exposure Effects on 
Population''
Project 1.1, ``Dose Reconstruction for the Population Subjected to 
Radiation in the Urals''
    Objectives: To reconstruct, validate and analyze data on individual 
radiation doses received by the population so that these can be used in 
studies assessing the risks of developing cancer in exposed 
populations.
Project 1.2, ``Risk Estimation of the Carcinogenic Effects in the 
Population Residing in the Region of the Industrial Association 
``MAYAK''
    Objectives: To conduct studies to determine the risk of cancer in 
population groups exposed to radioactive contaminants in the region, to 
characterize the quality and validity of the data for conducting such 
studies, and to preserve the existing data using modern technologies.
Direction 2: ``Medical Consequences of Occupational Exposure to 
Radiation''
Project 2.1, ``Metabolism and Dosimetry of Plutonium Industrial 
Compounds''
    Objectives: To conduct a joint analysis of the data collected by 
the U.S. Transuranium and Uranium Registry (USTUR) and the dosimetry 
registry at MAYAK on deceased people with occupational exposure to 
radiation. The results would be useful for validating and improving 
radiation protection standards.
Project 2.2, ``Risk Estimation for Cancerous Effects of Occupational 
Exposure''
    Objectives: To determine risk estimates for cancer as a result of 
prolonged occupational exposure to radiation, from both external 
sources and internally-deposited radioactive compounds.
Project 2.3, ``Non-Cancerous Effects of Occupational Exposure to 
Radiation''
    Objectives: To validate and analyze the data on acute and chronic 
effects of radiation, other than cancer, observed in a large number of 
workers at the MAYAK facility.
    Applicants are encouraged to augment any of the projects in 
Directions 1 and 2.

C. Structure of Cooperative Agreements

    Cooperative agreements funded under this announcement will 
generally have two phases. Initial funding for each new cooperative 
agreement will be for a phase I feasibility assessment. Up to 15 
cooperative agreements may be awarded, totalling approximately $1.5 
million. Phase I may last up to one (1) year. Phase II, if warranted, 
will be funded through continuation awards under the same cooperative 
agreement. Phase II could continue up to four (4) years, renewable 
annually. Continuation awards for phase II, if made, will be based on 
the results from phase I, the availability of funds, and negotiation of 
the costs for phase II. Only those who participate in phase I will be 
eligible to participate in phase II.
Phase I
    During phase I, awardees will conduct a feasibility assessment. The 
feasibility assessment will include a review of site-specific 
information and an analysis of this and other information to 
demonstrate the feasibility of conducting the proposed research. DOE 
will play an active role in facilitating awardees' access to Russian 
scientists as described in Section VII (``DOE's Role'') below. During 
phase I, investigators will conduct the following tasks:

    1. Establish cooperative relationships with Russian scientists 
and institutions;
    2. Identify existing information relevant to exposure and health 
outcomes among target populations;
    3. Determine the most significant impediments to conducting the 
proposed project and propose strategies to overcome them;

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    4. Demonstrate the feasibility of conducting the proposed 
project;
    5. Develop a detailed technical proposal and budget for phase 
II; and
    6. Attend annual DOE-coordinated meetings to share information 
on projects.

    Using the information developed in tasks 1-4, investigators will be 
expected to produce a feasibility assessment, as well as a technical 
proposal and proposed budget for phase II. The feasibility assessment, 
technical proposal, and proposed phase II budget should be delivered to 
DOE at least sixty (60) days prior to the conclusion of phase I. The 
process and the criteria used by the DOE to review these documents will 
be described in detail in the award documents for phase I. This process 
is intended to provide a seamless transition to phase II.
Phase II
    DOE will determine the need for phase II activities as described 
above and, if appropriate, will support these efforts through 
continuation awards. Where phase II plans are approved by DOE, the 
investigators will conduct the following tasks:

    1. Conduct the research project developed in phase I;
    2. Periodically communicate results to the DOE;
    3. Publish the research results in peer reviewed scientific 
journals; and
    4. Attend annual DOE-coordinated meetings of researchers to 
share information on projects.

IV. Applications

    This Notice of Availability is issued pursuant to DOE regulations 
contained in 10 CFR part 602: ``Epidemiology and Other Health Studies 
Financial Assistance Program,'' as published in the Federal Register on 
January 31, 1995 (60 FR 5841). 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. 10 CFR part 602 contains the 
specific requirements for applications, evaluation, and selection 
criteria. Only those applications following these specific criteria and 
forms will be considered. Application forms and information on the 
Russian institutions currently participating in JCCRER-coordinated 
studies, set forth in Section II (``Background''), may be obtained at 
the address cited above.

A. Proposal Format

    The formal proposal shall contain two sections, technical and cost. 
Technical proposals shall be no more than twenty-five (25) pages in 
length; resumes of proposed key personnel should be submitted as an 
appendix to the technical proposal and will not be counted against the 
page limit. Cost proposals shall have no page limit. It is imperative 
that the proposals be organized into phase I and phase II. Because the 
scope of phase II is dependent on the results of phase I, the technical 
description for phase II may be less specific than that for phase I, 
but must clearly demonstrate a capability to conduct phase II. The 
following format must be followed:
    a. Abstract--This should be a 1 page summary of the specific aims, 
background, significance, and research design and methods.
    b. Specific Aims--State the long-term objectives and describe what 
the specific research in this plan is intended to accomplish and the 
hypothesis to be tested.
    c. Project Description--Describe the research design and the 
procedures to be used to accomplish the specific aims of the project. 
At a minimum, the tasks listed under Section III.C. above (``Structure 
of Cooperative Agreements'') must be described (in detail for phase I 
tasks and more generally for phase II tasks). The project description 
must include clear statements of what is known, what is uncertain, and 
what new knowledge would be added by the proposed study.
    d. Personnnel--Proposals must demonstrate the competency of 
research personnel and the adequacy of resources. Proposals must 
demonstrate that the applicant has the experience and capability to 
plan, organize, manage, and implement the proposed work. Proposals must 
identify the technical and scientific staff that will actually conduct 
the studies and detail their professional experience. Proposals must 
demonstrate that the offeror has a demonstrated skill in planning and 
scheduling projects of comparable magnitude to the project it is 
proposing under this Notice.
    e. Cost--The cost proposal for phase I must include a summary 
breakdown of all costs and provide a detailed breakdown of costs on a 
task-by-task basis. Costs for phase II tasks may be more general 
estimates since the initial award will be for phase I only. Any 
expectation concerning cost sharing with non-DOE entities must be 
clearly stated. The cost proposal for phase I shall include an estimate 
of the costs of Russian scientists and institutions.

B. Evaluation and Selection

    Formal applications will be subjected to formal merit review (peer 
review) and will be evaluated against the following criteria listed in 
descending order of importance and codified at 10 CFR 602.9(d):

    1. Scientific and technical merit of the proposed research;
    2. Appropriateness of the proposed method or approach;
    3. Competency of research personnel and adequacy of proposed 
resources; and
    4. Reasonableness and appropriateness of the proposed budget.

    Formal applications will be peer reviewed by evaluators apart from 
DOE employees and contractors as described in the Office of 
Environment, Safety and Health's Merit Review System (57 FR 55524, 
November 25, 1992) and at 10 CFR 602.9(c). Submission of an application 
constitutes agreement that this is acceptable to the investigator(s) 
and the submitting institution. In accordance with 10 CFR 602.9(e), and 
as described in above in Section II (``Background''), a program policy 
factor for DOE that will be considered in selection is the economies 
introduced when a project builds upon existing epidemiologic studies. 
Specifically, DOE will not consider funding new radiation health 
effects studies ``starting from scratch'' where most of the 
epidemiologic and dosimetry data need to be developed de novo.

V. DOE's Policy on Protection of Human Subjects Reviews

    The Federal Policy for the Protection of Human Subjects, in 10 CFR 
part 745 (the ``Common Rule''), has special provisions for 
international research which apply to any awards made under this Notice 
of Availability. DOE approval of research conducted outside of the 
United States is subject to the ``Common Rule,'' or equivalent laws and 
regulations of the country in which research is conducted, whichever 
represents the greater level of protection for the research subject. 
DOE will work with awardees during phase I, as necessary, to ensure 
that research conducted by Russian scientists collaborating with phase 
I awardees comports with the required level of protection of human 
subjects and adequately addresses the issue of informed consent. 
Information on protecting human research subjects (within DOE) can be 
obtained from Dr. Ruth Neta at the address listed above.

VI. Applicants

    Applicants for the cooperative agreements may include domestic 
nonprofit and for profit organizations, universities, medical centers, 
research institutions, other public and private organizations, 
including small, minority or women-owned businesses. Consortiums of 
interested organizations

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are encouraged to apply. Awardees for each study will need to work 
cooperatively with Russian scientists, and governmental and non-
governmental institutions and organizations.

VII. DOE's Role

    For DOE to use cooperative agreements for these studies, there must 
be substantial involvement between DOE and any awardee. DOE established 
the subject area for these projects, the core tasks for phase I and 
prepared this Notice of Availability. DOE will conduct the evaluation, 
selection, and award process for applications submitted pursuant to 
this Notice. If necessary, DOE will facilitate contact between phase I 
awardees with scientists and institutions in the Russian Federation 
listed in Section II (``Background''). DOE will evaluate the results of 
phase I and, where warranted and subject to available funding, 
authorize and fund phase II continuation awards. In addition, DOE will 
establish requirements for data collection and handling. DOE also will 
consult with project investigators and coordinate annual meetings. 
Finally, DOE will monitor and evaluate the results of the projects to 
determine how these studies will contribute to DOE's ongoing efforts to 
improve health and safety programs for its workers.

    Issued in Washington, D.C., on June 10, 1997.
Paul J. Seligman,
Deputy Assistant Secretary for Health Studies.
[FR Doc. 97-15960 Filed 6-17-97; 8:45 am]
BILLING CODE 6450-01-P