[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
FW: Office of Environment, Safety and Health; Notice of
> [Federal Register: February 22, 2000 (Volume 65, Number 35)]
> [Notices]
> [Page 8688-8695]
Sorry for the long post, but some of you may be interested in this....
> >From the Federal Register Online via GPO Access [wais.access.gpo.gov]
> [DOCID:fr22fe00-37]
>
> -----------------------------------------------------------------------
>
> 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.
>
> -----------------------------------------------------------------------
>
> 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:
> ruth.neta@eh.doe.gov; or Ms. Elizabeth White, telephone: (301) 903-
> 7582; facsimile: (301) 903-1413; electronic mail:
> elizabeth.white@eh.doe.gov.
>
> 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:
> <bullet> Branch Number 1 of the Biophysics Institute (FIB-1),
> Ozersk (Dr. Sergey Romanov, Director, romanov@fib1gnc.chel-65.chel.su);
> <bullet> Mayak Production Association, Ozersk; (Dr. Evgenii
> Vasilenko, Senior Engineer, rel@envc.chel.su); and
> <bullet> Urals Research Center for Radiation Medicine (URCRM),
> Chelyabinsk (Dr. Alexander Akleyev, Director, akleyev@urcrm.chel.su).
> 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
>
>
************************************************************************
The RADSAFE Frequently Asked Questions list, archives and subscription
information can be accessed at http://www.ehs.uiuc.edu/~rad/radsafe.html