[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Pages 8688-8695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4136]


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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 to support U.S.-Russian population-based studies 
on low dose-rate radiation health effects in the Russian Federation. 
This Notice is issued subsequent to the more general

[[Page 8689]]

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 applications is May 9, 2000.

ADDRESSES: U.S. Department of Energy, Office of International Health 
Programs, EH-63/270CC, 19901 Germantown Road, Germantown, Maryland 
20874-1290. Seven (7) copies of each application should be provided to 
the above address.

FOR FURTHER INFORMATION CONTACT: Requests for further information on 
this announcement may be directed to Dr. Ruth Neta, telephone: (301) 
903-1757; facsimile: (301) 903-1413; electronic mail: 
[email protected]; or Ms. Elizabeth White, telephone: (301) 903-
7582; facsimile: (301) 903-1413; electronic mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Purpose
II. Background
III. Applicants
IV. Applications
V. Phase I Application Evaluation and Selection
VI. DOE's Policy on Protection of Human Subjects Reviews
VII. DOE's Role
VIII. Notices on Lobbying Restrictions and American Made Products
IX. Intellectual Property Annex to the U.S.-Russian Agreement
X. U.S.-Russian Joint Coordinating Committee for Radiation Effects 
Research (JCCRER) General Data Access Provisions
XI. Addendum--Ongoing U.S.-Russian Joint Coordinating Committee for 
Radiation Effects Reseach (JCCRER) Studies

I. Purpose

    A. The Office of International Health Programs, in partnership with 
the Russian Federation, funds research on the health consequences 
(cancer and other diseases) of exposure to low-dose rate ionizing 
radiation. These ongoing studies are coordinated through the U.S.-
Russian Joint Coordinating Committee for Radiation Effects Research 
(JCCRER).
    B. The purpose of this Notice is to encourage the submission of 
applications for new joint U.S.-Russian feasibility studies on cohorts 
exposed to chronic low-dose rate ionizing radiation as a result of 
nuclear weapons production in the Russian Federation. Specifically, 
applications in the following fields will be considered:
    1. Epidemiology and related dosimetry/dose reconstruction; and
    2. Molecular epidemiology/biomarkers of disease due to radiation 
exposure.
    C. Where possible, applications for joint multi-disciplinary 
efforts that combine epidemiology and dosimetry are encouraged.
    D. At this time, consideration will not be given to applications:
    1. For research on populations exposed as a result of nuclear power 
incidents such as the Chernobyl accident;
    2. For research on populations exposed as a result of testing 
conducted at the Semipalatinsk Test Site;
    3. For validation of dosimetry (e.g., through Electron Paramagnetic 
Resonance, Fluorescent In-Situ Hybridization, and Thermoluminesence, 
etc.), either as a component of a retrospective physical dose 
reconstruction effort or as an independent study; or
    4. For cross-generational studies.
    E. DOE anticipates that approximately $1,000,000 may be available 
in fiscal year 2000 to support up to five new projects initiated, 
through cooperative agreements, as a result of this Notice. Information 
from these 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.
    F. Addendum XI will provide potential applicants with background 
information on JCCRER studies conducted to date. Descriptions of 
cohorts included in this section are limited to those of cohorts 
subject to ongoing JCCRER studies and are not intended to: (1) Be 
representative of all related studies in the Russian Federation; or (2) 
indicate a preference to support studies on these populations over 
others exposed as a result of nuclear weapons production in the Russian 
Federation.

II. Background

    A. The JCCRER is a bilateral Government committee representing 
Federal agencies from the United States and ministries from the Russian 
Federation. It was 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 (U.S.--Russian Agreement), 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.
    B. Radiation health effects 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, and grossly 
contaminated sites or facilities.
    C. 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, the Mayak Production 
Association (MAYAK), was established by the Soviet Union in the 
Southern Urals, about 100 km northwest 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 MAYAK occurred from 1949-1956. As a result, thousands of 
people residing along the Techa River received significant radiation 
exposures. Furthermore, because of limited and inadequate (by today's 
standards) radiation protection measures and procedures, thousands of 
MAYAK workers were overexposed to radiation.
    D. The current U.S. JCCRER members are the:
    1. U.S. Department of Energy (DOE);
    2. U.S. Nuclear Regulatory Commission (NRC);
    3. U.S. Department of Health and Human Services (HHS);
    4. U.S. Department of Defense (DoD);
    5. U.S. National Aeronautics and Space Administration (NASA); and
    6. U.S. Environmental Protection Agency (EPA).
    E. The current Russian JCCRER members are the:
    1. Ministry for Civil Defense Affairs, Emergencies and Elimination 
of Consequences of Natural Disasters (EMERCOM);
    2. Ministry of Atomic Energy (MINATOM); and
    3. Ministry of Health (MINZDRAV).

III. Applicants

    A. An applicant must be a U.S. organization(s), and applications 
must include participation by both a U.S. organization(s) and a Russian 
organization(s). U.S. applicants may include, but are not limited to, 
nonprofit and for profit organizations, universities, medical centers, 
research institutions, and other public and private organizations, 
including small, minority or women-owned businesses,

[[Page 8690]]

as well as consortiums of interested organizations. Applications, if 
accepted, will be awarded through cooperative agreements. Russian 
participants will be directly funded through implementing arrangements 
under the auspices of the U.S.-Russian Agreement.
    B. Applications submitted by, or on behalf of (1) another Federal 
agency; (2) a Federally-Funded Research and Development Center 
sponsored by a Federal agency; or (3) a DOE Management and Operating 
(M&O) contractor will not be eligible for an award under this RFA. 
However, as described below in Section IV(C), Application Format, an 
application that includes performance of a portion of the work by a DOE 
M&O contractor under a cooperative agreement may be considered for 
award.
    C. Applicants are subject to applicable requirements of 10 CFR part 
600, Financial Assistance Rules, and 10 CFR part 602, Epidemiology and 
Other Health Studies Financial Assistance Program.
    D. Intellectual property created or furnished under any cooperative 
agreements awarded pursuant to this request for applications will be 
subject to the intellectual property annex to the U.S.-Russian 
Agreement, set forth in Section IX. In addition, generated data will be 
treated in accordance with the JCCRER General Data Access Provisions 
set forth in Section X. The applicable terms and conditions of the data 
clauses of 10 CFR 600.27 also will apply if included in the cooperative 
agreements. It is not anticipated that inventions will be made in 
performance of work under the cooperative agreements and, therefore, 
the patent rights clauses of 10 CFR 600.27 will not be included in the 
cooperative agreements.

IV. Applications

A. General

    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.

B. Structure of Cooperative Agreements

    1. Cooperative agreements funded under this announcement may have 
two phases. Initial funding for each new cooperative agreement will be 
for a Phase I feasibility assessment and, if requested by DOE, 
development of a Phase II proposal. Phase I will last up to eighteen 
(18) months. Phase II, if warranted, will be funded through 
continuation awards. 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.
    2. 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. During 
Phase I, investigators will conduct the following tasks:
    a. Demonstrate the feasibility of conducting the proposed project 
and determine any significant impediments to conducting the proposed 
project, as well as proposed strategies to overcome them;
    b. Attend periodic DOE-coordinated meetings to share information on 
projects; and
    c. Upon notification by DOE following review of the feasibility 
assessment, develop a detailed technical proposal and budget for Phase 
II.
    3. Using the information developed in Task a, investigators will be 
expected to produce a feasibility assessment to be delivered one (1) 
year after the award is made. Based on the external review of the 
feasibility assessment by DOE's standing bi-national Scientific Review 
Group (an advisory panel for DOE-funded U.S.-Russian radiation health 
effects research), as well as an internal review by DOE's Office of 
International Health Programs, DOE will make a determination as to 
whether to request a long-term proposal for Phase II. Upon notification 
by DOE, the Phase II technical proposal and proposed budget should be 
prepared. The complete proposal should be submitted at least ninety 
(90) days prior to the conclusion of Phase I. The process and criteria 
used by the DOE to review these documents will be described in detail 
in the award documents for Phase I. The process is intended to provide 
a seamless transition to Phase II.
    4. 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 perform the following tasks:
    a. Conduct the research project developed in Phase I;
    b. Periodically communicate results to DOE;
    c. Publish the research results in peer reviewed scientific 
journals; and
    d. Attend periodic DOE-coordinated meetings of researchers to share 
information on projects.

C. Application Format

    1. An application shall be submitted by the U.S. organization(s). 
The application shall contain two sections, technical and cost.
    a. Technical applications must contain separate technical 
descriptions for Phase I and Phase II, which are described in Section 
IV(B), Structure of Cooperative Agreements. 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 technical 
application shall be no longer than 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. The 
following format must be followed for the technical application:
    i. Abstract--Provide a 1-page summary of the specific aims, 
background, significance, and research design and methods.
    ii. 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.
    iii. 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 IV(B), 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.
    iv. Resources--Demonstrate the competency of research personnel and 
the adequacy of resources. Applications must demonstrate that the 
applicant has the experience and capability to plan, organize, manage, 
and implement the proposed work. Applications must identify the 
technical and scientific staff who will conduct the studies and detail 
their professional experience and other

[[Page 8691]]

sources of support. Applications 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.
    b. Cost proposals shall have no page limit and shall include, for 
Phase I, 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. The cost proposal for Phase I shall include an estimate of the 
costs of the Russian participating organization(s).
    2. An application that includes performance of a portion of the 
effort by a DOE M&O contractor will be evaluated and considered for 
award pursuant to Section V, Phase I Application Evaluation and Award, 
provided that the application meets the following criteria:
    a. Prior to submission of an application to DOE, the DOE 
Contracting Officer for the M&O contractor must provide written 
authorization for the DOE M&O contractor to perform the proposed scope 
of work. Pursuant to this authorization, the DOE Contracting Officer 
must determine that performance by the M&O contractor: (1) Is 
consistent with or complementary to DOE missions and the missions of 
the facility to which the work is to be assigned; (2) will not 
adversely impact execution of the assigned programs of the facility; 
(3) will not place the facility in direct competition with the domestic 
private sector; and (4) will not create a detrimental future burden on 
DOE resources. The DOE Contracting Officer's authorization shall be 
included in the application.
    b. An application must include a description of: (1) The scope of 
work to be performed by the applicant and the scope of work to be 
performed by the M&O contractor; and (2) the managerial arrangement 
between the applicant and the M&O contractor. The scope of work to be 
performed by the M&O contractor may not be more significant than the 
scope of work to be performed by the applicant and the Russian 
participating organization(s). Prior to submitting an application for 
review as set forth in Section V, Phase I Application Evaluation and 
Selection, DOE will review the application to determine that it meets 
this criteria and reserves the right to reject any application that 
fails to do so.
    c. DOE intends to fund an approved M&O contractor scope of work 
through a DOE Field Work Proposal from the Office of International 
Health Programs to the DOE Operations Office overseeing the M&O 
contractor at issue. The M&O contractor's work scope, therefore, should 
not be accomplished through a contract with a recipient as defined in 
10 CFR Part 600.3. Applications must include a form DOE F 4620.1 and 
budget page for the applicant's portion of the project, and a Field 
Work Proposal cover page and budget pages (see DOE Order 5700.7C) for 
the M&O contractor's scope of work.
    3. If an applicant uses an M&O contractor to perform a portion of 
the work under the cooperative agreement, the applicant will be the 
responsible authority, without recourse to DOE, regarding the 
settlement and satisfaction of all contractual and administrative 
issues, including, but not limited to, disputes and claims, arising out 
of any agreement between the applicant and the M&O contractor.

V. Phase I Application Evaluation and Selection

    1. Applications will be subjected to merit review (ad hoc peer 
review) and will be evaluated against the following criteria listed in 
descending order of importance and codified at 10 CFR 602.9(d):
    a. Scientific and technical merit of the proposed research;
    b. Appropriateness of the proposed method or approach;
    c. Competency of research personnel and adequacy of proposed 
resources; and
    d. Reasonableness and appropriateness of the proposed budget.
    2. Applications will be peer reviewed by evaluators apart from DOE 
employees and contractors 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). The review will consist of an initial 
comprehensive review by an ad hoc group of experts in the field, 
followed by a second-tier independent review of the most highly ranked 
proposals by DOE's standing bi-national Scientific Review Group.
    3. Following the feasibility phase, DOE's standing bi-national 
Scientific Review Group will evaluate the promise of feasibility 
studies for long-term (Phase II) study. This group will also serve to 
evaluate, every six (6) months, progress of all DOE-funded long-term 
studies and the success of completed projects.

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

    A. 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 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.
    B. DOE will work with awardees during Phase I, as necessary, to 
ensure that research conducted with Russian participant(s) 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. Susan 
Rose at the address listed above.

VII. DOE's Role

    For DOE to use cooperative agreements for these studies, there must 
be substantial involvement between DOE and each awardee. DOE 
established the subject area for these projects, the core tasks for 
Phase I and prepared this Notice of Availability. DOE will ensure a 
two-tier external evaluation and will make final selections and awards 
for applications submitted pursuant to this Notice. DOE, with input 
from its standing bi-national Scientific Review Group, will evaluate 
the results of Phase I and, where warranted and subject to available 
funding, authorize and fund Phase II continuation awards. 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.

VIII. Notices on Lobbying Restrictions and American-Made Products

A. Lobbying Restrictions (Energy and Water Act, 2000)

    The awardee agrees that none of the funds obligated this award 
shall be expended, directly or indirectly, to influence congressional 
action on any legislation or appropriation matters pending before 
Congress, other than to communicate to Members of Congress as described 
in 18 U.S.C. 1913. This restriction is in addition to those prescribed 
elsewhere in statute and regulation.

B. Notice Regarding the Purchase of American-Made Equipment and 
Products--Sense of Congress

    It is the sense of the Congress that, to the greatest extent 
practicable, all equipment and products purchased

[[Page 8692]]

with funds made available under this award should be American-made.

IX. Intellectual Property Annex to the U.S.-Russian Agreement

Pursuant to Article VI of this Agreement:

    The Parties shall ensure adequate and effective protection of 
intellectual property created or furnished under this Agreement and 
relevant implementing arrangements. The Parties agree to notify one 
another in a timely fashion of any inventions or copyrighted works 
arising under this Agreement and to seek protection for such 
intellectual property in a timely fashion.
    Rights to such intellectual property shall be allocated as provided 
in this Annex.

I. Scope

    A. This Annex is applicable to all cooperative activities 
undertaken pursuant to this Agreement, except as otherwise specifically 
agreed to by the Parties or their designees.
    B. For purposes of this Agreement, intellectual property shall have 
the meaning found in Article 2 of the Convention establishing the World 
Intellectual Property Organization, done at Stockholm, July 14, 1967.
    C. This Annex addresses the allocation of rights, interests, and 
royalties between the Parties. Each Party shall ensure that the other 
Party can obtain the rights to intellectual property allocated in 
accordance with the Annex, by obtaining those rights from its own 
participants through contracts or other legal means, if necessary. This 
Annex does not otherwise alter or prejudice the allocation between a 
Party and its nationals, which shall be determined by the Party's laws 
and practices.
    D. Disputes concerning intellectual property arising under this 
Agreement should be resolved through discussions between the concerned 
participating institutions or, if necessary, the Parties or their 
designees. Upon mutual agreement of the Parties, a dispute shall be 
submitted to an arbitrate tribunal for binding arbitration in 
accordance with the applicable rules of international law. Unless the 
Parties or their designees agree otherwise in writing, the arbitration 
rules of the UNCITRAL shall govern.
    E. Termination or expiration of the Agreement shall not affect 
rights of obligations under this Annex.

II. Allocation of Rights

    A. Each Party shall be entitled to a non-exclusive, irrevocable, 
royalty-free license in all countries to translate, reproduce, and 
publicly distribute scientific and technical journal articles, reports, 
and books directly arising from cooperation under this Agreement. All 
publicly distributed copies of a copyrighted work prepared under this 
provision shall indicate the names of the authors of the work unless an 
author specifically declines to be named.
    B. Rights to all forms of intellectual property, other than those 
rights described in Section II(A) above, shall be allocated as follows:
    1. Researchers and scientists visiting in furtherance of their 
education shall receive intellectual property rights under the existing 
rules of the host institution. In addition, each visiting researcher or 
scientist named as an inventor shall have the right to national 
treatment regarding awards, benefits or other compensation, including 
royalties, in accordance with the existing rules of the host 
institution.
    2. (a) For intellectual property created during joint research, for 
example, when the Parties, participating institutions, or Participating 
personnel have agreed in advance of the scope of work, each Party shall 
be entitled to obtain all rights and interests in its own territory. 
Rights and interests in third countries will be determined in 
implementing arrangements. The rights to intellectual property shall be 
allocated with due regards for the economic, scientific and 
technological contributions from each Party to the creation of 
intellectual property. If research is not designated as ``joint 
research'' in the relevant implementing arrangement, rights to 
intellectual property arising from the research will be allocated in 
accordance with Paragraph II(B)(I). In addition, each person named as 
an inventor shall have the right to national treatment regarding 
awards, benefits and other compensation, including royalties, in 
accordance with the existing rules of the host institution. (b) 
Notwithstanding Paragraph II(B)2(A), if a type of intellectual property 
is available under the laws of one party but not the other Party, the 
Party whose laws provide for this type of protection shall be entitled 
to all rights and interests worldwide. Persons named as inventors of 
the property shall nonetheless be entitled to royalties as provided in 
Paragraph II(B)2(a).

III. Business-Confidential Information

    In the event that information identified in a timely fashion as 
business-confidential is furnished or created under the Agreement, each 
Party and its participants shall protect such information in accordance 
with applicable laws, regulations and administrative practice. 
Information may be identified as ``business-confidential'' if a person 
having the information may derive an economic benefit from it or may 
obtain competitive advantage over those who do not have it, the 
information is not generally known or publicly available from other 
sources, and the owner has not previously made the information 
available without imposing in a timely manner an obligation to keep it 
confidential.

X. U.S.-Russian Joint Coordinating Committee for Radiation Effects 
Research (JCCRER) General Data Access Provisions

Introduction

    The purpose of this data access agreement is to ensure that 
scientists of the Russian Federation and American scientists working on 
projects under the U.S.-Russian Agreement have equal access to all 
primary and original Russian and American data necessary to conduct the 
work described under Directions 1 and 2 of the Agreement. Such access 
will ensure the highest quality of scientific research conducted in an 
atmosphere of mutual trust and cooperation.

General Provisions

    1. For the purposes of this agreement on data access, data is 
defined as all information, in whatever format or media, that is 
identified by any of the Principal Investigators and Directors of 
participating institutes as necessary to carry out the project.
    2. Privacy statutes in Russia and the United States generally 
restrict access to data which includes personal identifiers. Individual 
data, however, is the basis of much of the research work of the JCCRER. 
Therefore, where necessary, adherence to these statutes will be ensured 
by substituting unique numerical identifiers which protect individual 
privacy while allowing analysis of individual and aggregate data.
    3. Data covered by this access agreement include original or raw 
data, compiled data created before these projects were begun, and 
second generation or summarized data and information compiled according 
to project requirements. The specific project agreement provisions will 
specify the actual data which fall under each of these categories. 
Appropriate access to all these data must be ensured; however, original 
or raw data, and compiled data created before these projects were begun 
remain the property of that organization and that country

[[Page 8693]]

where the data were obtained and are currently maintained.
    4. Secondary data created as part of JCCRER projects, which are a 
joint scientific product, will be jointly owned by the Russian and the 
American institutions participating in the project. Each project will 
determine what is a scientific product of the collaboration and, 
therefore, subject to joint ownership.
    5. Project participants have the right to appropriate access to 
original, compiled and secondary data on the territory of the 
organization which owns and maintains the data.
    6. The specific project agreement provisions will identify the kind 
and extent of unpublished primary, compiled, and secondary data that 
may be transferred out of the country of ownership to achieve specific 
project goals such as technical analyses, modeling, etc., at the home 
institution of researchers. When such data transfers occur, they must 
also be approved in writing by the Director of the institute or 
organization to which the data belong. Transferred data cannot be used 
for purposes other than those specified by the agreement, even after 
the project is completed or the researcher is no longer associated with 
the JCCRER. In cases where such data are transferred to people who are 
not participants in the project for the purposes of furthering the 
project, the same conditions and limitations on use of data apply. Such 
transfers will be carefully scrutinized.
    7. No transfers, publications, presentations, press releases or any 
other form of communication to the outside world regarding details of 
the unpublished data or the unpublished results of studies conducted 
under the authority of the JCCRER will be made without the written 
consent, and participation of the institutions maintaining the data 
sets and the scientists involved in the research. Any agreement to make 
data publicly available must be approved by the Directors of 
organization performing the research. Scientists and specialists 
participating as current members of the JCCRER Joint Committee, 
Executive Committee, and Scientific Review Groups have a right to 
review data and unpublished results of studies as appropriate to their 
responsibilities, but are similarly bound by the restrictions on 
communication as described in this paragraph.
    8. Dissemination of scientific results, in the form of 
presentations at scientific meetings and publications in referred 
journals, is regarded as an essential product of the JCCRER work. To 
ensure that such communications take place while complying with the 
requirements of the participating institutions and funding agencies, 
procedures will be developed for the expeditious review and approval of 
such communication requests from the principal investigators.
    9. Data published in the open, peer-reviewed literature shall be 
referenced and used according to generally understood and accepted 
conventions of scientific conduct; it is expected that proper reference 
and credit to the origin of the published material will be made.
    10. After the publication of reports, third parties may request 
access to unpublished study data that does not contain individual 
identifiers, in order to conduct independent analyses. Third parties 
are defined as experts in the field of radiation health effects and 
dosimetry who are not part of any JCCRER project. Procedures will be 
developed for requesting and approving third party access to primary 
data.

XI. Addendum--Ongoing U.S.-Russian Joint Coordinating Committee for 
Radiation Effects Research (JCCRER) Studies

A. Description of Ongoing JCCRER Projects

    The Russian scientific institutions currently conducting radiation 
health effects research under the auspices of the JCCRER include the:
     Branch Number 1 of the Biophysics Institute (FIB-1), 
Ozersk (Dr. Sergey Romanov, Director, [email protected]);
     Mayak Production Association, Ozersk; (Dr. Evgenii 
Vasilenko, Senior Engineer, [email protected]); and
     Urals Research Center for Radiation Medicine (URCRM), 
Chelyabinsk (Dr. Alexander Akleyev, Director, [email protected]).
1. Description of Cohorts Currently Under Study
    Two different epidemiologic research directions currently are 
supported by the JCCRER: (1) Studies of populations who live near the 
Techa River; and (2) studies of workers at the MAYAK facility.
    a. Techa River Population Cohort.
    The liquid discharges to the Techa River from MAYAK (due to 
inadequate storage of radioactive waste) occurred from 1949-56, with 95 
percent released in an eighteen (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 (30) 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.
    b. 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). As of 1994, 90 percent of this cohort had known vital 
status; 5,000 were dead; 1,000 had died of cancer; and more than 4,000 
had known plutonium body burdens. The average value of the equivalent 
dose to the lung for all workers with measured plutonium (Pu 239) body 
burden is 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 (83) 
percent of these were diagnosed as chronic radiation sickness caused by 
radiation exposures of 1 to 10 Gy. Forty-one (41) 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 pneumosclerosis (66 in individuals whose internal lung 
exposure exceeded 4.0 Gy) were diagnosed.

[[Page 8694]]

2. Tissues Available for Study from the Deceased Techa River Population 
and MAYAK Worker Cohorts
    Tissues available for study on the Southern Urals populations 
include those of the deceased Techa River population, stored at URCRM 
in Chelyabinsk, as well as those of the deceased MAYAK workers, located 
at FIB-1 in Ozersk. DOE is currently supporting an effort to establish 
a tissue repository at FIB-1, as described below.
    a. Establishment of Russian Human Radiobiology Tissue Repository at 
FIB-1 for Exposed MAYAK Workers.
    The repository consists of organs and tissues of 600 deceased MAYAK 
workers. Blood sample donations obtained with informed consent from 
living members of worker cohort, 1,200 of whom are currently residing 
in the city of Ozersk, will be added to this repository. Additionally, 
information on internal and external exposure records, on medical 
records, and on work history will be included in a computerized 
inventory currently under development for the tissues included in the 
repository.

Background Information on Formalin-fixed Tissue Materials From 180 
Donors Inventoried to Date

    (a) Internal organs:

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Intestine
                                                        Lung     Heart/    Stomach  Pancreas    Liver  --------------------  Spleen    Kidneys   Urinary
                                                                  aorta                                    Sm        Lg                          bladder
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of cases.....................................       180   172/103       132       135       180        24       117       159       176        30
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (b) Brain and other organs/tissues:

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Brain                                         Reproductive organs
                                                          -------------------------             Adre-  ----------------------------------------   Lymph
                                                                                     Thyroid    nals                Pros-                         nodes
                                                           Hemispheres  Cerebellum                       Testes     tate      Ovary    Uterus
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of cases..........................................         173         109        126       143       100        40         8        19        69
--------------------------------------------------------------------------------------------------------------------------------------------------------

Accumulated Doses of External y-exposure for the 180 Registrants

 
----------------------------------------------------------------------------------------------------------------
                                                                 Cumulative doses, Gy
                                               -------------------------------------------------------    Non-
                                                  0.05    0.051-   0.5-1.0   1.01-    2.01-     >4.0   monitored
------------------------------------------------------------0.5---------------2.0------4.0----------------------
Number of cases...............................       11        15        7       67       63       27        10
----------------------------------------------------------------------------------------------------------------

Plutonium Body Burden for the 180 Registrants

 
----------------------------------------------------------------------------------------------------------------
                                                          Body burden, kBq
                               ---------------------------------------------------------------------      No
                                 0-0.75   0.76-     1.51-    2.96-     5.91-      11.85-     >47.36  information
-------------------------------------------1.5------2.95------5.9------11.84-------47.36------------------------
Number of cases...............       34       19        24       19         8          31        18         47
----------------------------------------------------------------------------------------------------------------

    Ad hoc histology examination of tissue samples of 15 individuals 
showed preservation of structure of tissue materials stored in formalin 
for 10-20 years and their adequacy for utilization in morphology 
studies. Additionally, work with 10 paraffin blocks has shown promise 
for future DNA studies.
3. Current JCCRER Research Directions
    The JCCRER has initiated areas for study called Directions. 
Direction 1 focuses on the Techa River population and Direction 2 
focuses on the MAYAK workers. All projects are jointly conducted by 
both U.S. and Russian principal investigators and their respective 
teams of researchers, and are summarized below.
    A third JCCRER Direction, which is not related to this 
announcement, is focused on U.S.--Russian emergency preparedness/
response activities. The Russian Ministry for Emergencies is leading 
these activities for the Russian side.

[[Page 8695]]

Direction 1: Medical Aspects of Radiation Exposure Effects on 
Population

    1. 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. (U.S. support from DOE, with supplements from NASA and 
EPA--scheduled for completion in March 2000)
    2. Project 1.2: Risk Estimation of the Carcinogenic Effects in the 
Population Residing in the Region of the Mayak Production Association.
    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. 
(U.S. support from DOE on cancer incidence, the first component of 
which is scheduled for completion in March 2000, and data preservation 
projects; from National Cancer Institute (HHS) on cancer mortality 
project.)
    3. Project 1.3: Retrospective Reconstruction of Radionuclide 
Contamination of Techa River Caused by Liquid Waste Discharge from 
Radiochemical Production at the Mayak Production Association: 1949-
1956.
    Objectives: To supplement the population dose reconstruction study 
by providing additional information on the source term of radioactive 
materials released into the Techa River. (U.S. support from DOE--
completed in 1998.)

Direction 2: Medical Consequences of Occupational Exposure to Radiation

    1. 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 FIB-1/MAYAK on deceased people with occupational exposure 
to radiation. (U.S. support from DOE--scheduled for completion in March 
2000.)
    2. Project 2.2: Risk Estimation for Stochastic (Carcinogenic) 
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. (U.S. support 
from DOE.)
    3. 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 Production Association. (U.S. support from NRC.)
    4. Project 2.4: Reconstruction of Individual Doses of Exposure to 
Mayak Production Association Workers.
    Objectives: To develop an electronic database of reconstructed 
doses for external and internal exposures received by the MAYAK worker 
cohort. (U.S. support from DOE.)

Additional DOE Office of International Health Programs-Funded Direction 
2 Studies

    The Office of International Health Programs awarded five 
cooperative agreements in August 1998 for fifteen (15) month 
feasibility studies to support ongoing joint U.S.-Russian studies in 
the Southern Urals on low dose-rate radiation health effects. These new 
studies were aimed at adding a molecular epidemiology/biodosimetry 
component to the ongoing epidemiologic and dose reconstruction work of 
the JCCRER. The feasibility studies have been jointly conducted by the 
FIB-1 in Ozersk and U.S. institutions, and the following two have 
proceeded as Phase II studies.
    1. Improved Dosimetry and Risk Assessment for Plutonium-Induced 
Lung Disease Using a Microdosimetric Approach
    Objectives: To determine plutonium distribution in relation to 
pathology in preserved tissues.
    2. Establishment of a Repository Containing Tissues and Organs of 
Deceased Workers of the Mayak Production Association Who Were Exposed 
to Actinide Elements.
    Objectives: To establish a human tissue repository for cytogenetic 
and molecular biological research at FIB-1 in Ozersk.

    Issued in Washington, D.C., on February 11, 2000.
Paul J. Seligman, M.D., M.P.H.,
Deputy Assistant Secretary for Health Studies.
[FR Doc. 00-4136 Filed 2-18-00; 8:45 am]
BILLING CODE 6450-01-P