Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	The Chernobyl Tissue Bank - Coordinating Center (Limited Competition U24)
Activity Code	U24 Resource-Related Research Projects Cooperative Agreements
Announcement Type	Reissuance
Related Notices	September 30, 2016 - This RFA has been reissued as RFA-CA-16-502.
Funding Opportunity Announcement (FOA) Number	RFA-CA-12-501
Companion FOA	None
Number of Applications	Eligible applicant organization may submit only one application in response to this FOA. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393, 93.396, 93.399
FOA Purpose	This National Cancer Institute (NCI) limited competition Funding Opportunity Announcement (FOA) solicits the renewal application for the Chernobyl Tissue Bank (CTB) Coordinating Center. The CTB is a collaborative project that is supported by the NCI and other international partners and involves active participation of countries heavily affected by the Chernobyl nuclear accident. The mission of the CTB is to maintain a research resource that supports current and future studies on the biology of thyroid cancer, a major health consequence of the Chernobyl accident. The CTB Coordinating Center is a critical component that serves these goals.

Posted Date	December 13, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	February 15, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	May-June 2012
Advisory Council Review	August 2012
Earliest Start Date(s)	September 1, 2012
Expiration Date	February 16, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This National Cancer Institute (NCI) limited competition Funding Opportunity Announcement (FOA) solicits the renewal application for the Chernobyl Tissue Bank (CTB) Coordinating Center. The CTB is a collaborative project that is supported by the NCI and other international partners and involves active participation of countries heavily affected by the Chernobyl accident. The mission of the CTB is to maintain a research resource that supports current and future studies on the biology of thyroid cancer, a major health consequence of the Chernobyl accident. The ultimate goal of the CTB is to promote innovative research on thyroid cancer related to radiation exposure. This research is expected to lead to a better understanding of thyroid cancer biology and more effective screening and treatment measures. The Coordinating Center is a critical component of the CTB infrastructure serving these goals.

The CTB Coordinating Center is located at the awardee institution and the repositories housed at the participating institutions in the Chernobyl-affected countries. For the CBT organizational structure and components, go to http://www.chernobyltissuebank.com/project.html. The CTB Coordinating Center functions to lead, plan, integrate, and conduct the proposed research studies in collaboration with the participating institutions. The Coordinating Center also supports CTB communications, data management, and bioinformatics.

Chernobyl Late Health Effects. Approximately 5 years after the Chernobyl accident, a significant increase in pediatric thyroid cancer cases was reported in Ukraine, Belarus, and Russia. International reports and recent studies have concluded that close to 5000 cases of thyroid cancer, mainly in children and adolescents at the time of the accident, have resulted from I131 contamination. This increase in incidence of thyroid cancer is still being observed in patients who were internally exposed to radioiodine from the plant as children or young adults. Whereas thyroid cancer has been the main late health manifestation of radiation exposure to date, increases in the incidence of other diseases have also been reported in liquidators of the Chernobyl plant but their association with radiation exposure needs further confirmation.

The Chernobyl Tissue Bank. The CTB is an international collaborative project that is supported by the NCI, the European Commission, and the Sasakawa Memorial Health Foundation of Japan. The project involves active participation of Russia and Ukraine as two of the countries affected by the Chernobyl accident. The objective of the CTB is to maintain a research resource that supports current and future studies on the biology of thyroid cancer. The CTB was established in 1998 following emerging evidence of increases in pediatric thyroid cancer in the Chernobyl affected population and NCI support for the project commenced in 2000 through a grant to the Coordinating Center. The incidence of thyroid cancer in children is normally very low but its sudden increase in the population that was exposed to Chernobyl fallout pointed to the need for immediate research efforts on the biology of Chernobyl-related thyroid cancer. Addressing this need required the availability of high quality thyroid cancer specimens that would be meticulously and ethically collected. The project has the support of the governments of the Russia and Ukraine. Details regarding the structure and collaborative support for the CTB can be found at http://www.chernobyltissuebank.com/project.html.

The CTB collects specimens (tumor tissues, matched normal tissues, blood) from patients who were at age of 19 years or younger (born after April 26, 1967) at the time of the Chernobyl accident. The CTB also collects specimens from patients who were born after January 1, 1987, who represent a closely matched cohort that has not been exposed to the radioactive iodine fallout but has developed sporadic thyroid cancer at a young age. Only specimens that are in excess to the patient’s required diagnosis and therapeutic needs are collected by the CTB. The project does not supply thyroid tissue parts to researchers, only tissue sections and extracted bioanalytes in order to preserve valuable specimens for future research and enable an extensive assessment of the tumors and their heterogeneity.

The CTB has established itself as an important model for research on the biology of thyroid cancer through scientific leadership and integrated research approaches. These approaches have facilitated the comprehensive collection of biological specimens and their clinical annotation from the affected patients as well as research results from participating projects. The CTB’s ongoing efforts to integrate raw research data from its samples with clinical information will further advance investigations on the biology of thyroid cancer.

CTB Structure and Management. The CTB is coordinated and administrated by the Coordinating Center located at Imperial College, London, United Kingdom, under the direction of Professor Geraldine Thomas, the Program Director/Principal Investigator (PD)/PI) on the current NCI award. The collection of biological specimens is conducted by the Institute of Endocrinology and Metabolism in Kiev, Ukraine, and the Medical Radiological Research Center in Obninsk (or one of its affiliates at the Regional Radiological Dispensary in Bryansk), Russia. These institutions collect, document, store, and process specimens and the associated clinical-pathological data from each consented human research participant in the project.

The CTB project is overseen by the CTB Steering Committee, which is composed of one senior representative from each funding agency as well as the participating institutions in the Chernobyl affected countries. An independent Scientific Advisory Board of international experts in various scientific disciplines advises the Steering Committee and the PD/PI on the scientific development and progress of the project. An international renowned Pathology Panel provides a consensus diagnosis for each case included in the CTB database.

CTB Biomaterials. The CTB has been successful in acquiring specimens from thyroid cancer patients from areas that were affected by radiation from the Chernobyl accident. To date, specimens from more than 3800 case patients have been collected and reviewed by the Pathology Panel. Information on the number and types of cases in the CTB archive that is available for research can be found on the CTB website (www.chernobyltissuebank.com) and is updated following each Pathology Panel meeting.

Access to the CTB biomaterials is available by application and following review and approval by the CTB External Review Panel and the Scientific Advisory Board, respectively.

The CTB should have an important role in promoting research on the biology of Chernobyl-related thyroid cancer. The CTB Coordinating Center is expected to fulfill this role through providing scientific, administrative, and logistic support for the collection and processing of specimens at the participating institutions in the Chernobyl accident-affected countries as well as facilitating research access to these specimens for qualified investigators across the globe. The CTB Coordinating Center must be able to connect and integrate activities at all the participating sites/countries and serve as the management center while minimizing duplication of efforts and resources. The CTB Coordinating Center is expected to have substantial responsibility in ensuring its continued self-evaluation and improvement.

To realize these tasks, the CTB Coordinating Center applicant must demonstrate leadership and expertise in coordinating a multi-site tissue banking program. It is essential that the proposed Coordinating Center provides infrastructure to support the statutory scientific activities of the CTB. This infrastructure must allow for monitoring and coordinating the joint activities of all the participating sites, providing logistical support for Steering Committee and advisory subcommittees meetings and site visits, preparing and disseminating reports, and other related functions.

The CTB applicant must have appropriate expertise and experience in the areas defined above. The applicant institution must have the necessary infrastructure to meet the specific requirements defined in this FOA.

The CTB Coordinating Center applicant must address the following strategic objectives (see also Section IV. Content and Form of Application Submission):

• Facilitate CTB research through scientific, administrative, and organizational oversight with emphasis on coordination of efforts, collaborations, and efficient communications across multiple research institutions and countries;
• Manage the Chernobyl repository that encompasses information on the availability of specimens in the CTB archive. The information must include these concerning regulatory approvals of specimen collection and the informed consent process;
• Create and manage relevant logistic infrastructures for specimen collection at the participating institutions;
• Establish and operate a centralized data collection, management, analysis, and dissemination core for the CTB (this infrastructure for data collection and archiving must meet standards for common data systems and aim at achieving compatibility with the NCI's caBIG);
• Facilitate the distribution of specimens to investigators with approved research access applications;
• Track the distribution of specimens to investigators, consistent with achieving the goals of the project;
• Facilitate and mediate communications between the NCI Program Official and other members of the Steering Committee to allow for efficient consultations and oversight of the project;
• Create opportunities to disseminate research results to the scientific community and general public;
• Assist the CTB Steering Committee in assembling appropriate advisory panels such as the Scientific Advisory Board, the Pathology Panel, and other relevant Working Groups;
• Provide logistical and administrative support for all the activities of the Steering Committee and its subcommittees and Working Groups; and
• Develop capacity to enable self-evaluation to promote effective self-correcting actions - for this goal, the CTB Coordinating Center should closely collaborate with the Steering Committee (see below), and the NCI Program Official.

Other goals and activities of the CTB are expected to be funded by the other international partners in the project (see also in the Background section).

The CTB will be governed by the CTB Steering Committee. Details on the composition and function of the Steering Committee are provided in Section VI. 2. Under "Terms and Conditions of Cooperative Agreement.

As the effectiveness of the funded research is an increasing priority for the NCI, the CTB Coordinating Center is expected to participate in an external evaluation process coordinated by the NCI Program Official. The purpose of the evaluation process is to monitor and assess the performance of the CTB toward achieving its goals. This process will include evaluating the quality and innovation of the CTB research approaches as well as the status of its archive, infrastructure development, and resource and data sharing arrangements with other investigators. In terms of the overall impact of the CTB, a particular focus area will be the improved understanding of thyroid carcinogenesis. The relevant measures of program success will be identified from the conceptual framework presented above and from other empirical scientific evidence.

Funding Instrument	Cooperative Agreement
Application Types Allowed	Renewal The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NCI intends to commit up to $250,000 (total costs) in FY 2012 to fund one award.
Award Budget	The application budget is limited to $250,000 (total costs) and should reflect the actual needs of the project.
Award Project Period	Applicants may request a project period of 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

This is a limited competition FOA. Only the current awardee institution (Imperial College, London, UK) is eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Director/Principal Investigator (PD/PI) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Any individualwith the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For this FOA, multiple PDs/PIs are NOT allowed.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Eligible applicant organization may submit only one application in response to this FOA.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

A Letter of Intent is not required.

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

All page limitations described in the PHS398 Application Guide and must be followed, with the following requirements:

• Specific Aims (including Impact Statement) is limited to 1 page.

Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to: 12 pages for the Overview of the CTB Project and its Coordinating Center and 12 pages for the CTB Coordinating Center Activities.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

• Table of Contents. Modify Form Page 3 of the PHS 398 (Table of Conents) to include under Section 3 Research Strategy the following subsections:

A. Overview of the CTB Project and its Coordinating Center; and

B. CTB Coordinating Center Activities

• Research Strategy. Section 3. Research Strategy of the PHS 398 Research Plan must consist of the following sub-sections A-B (corresponding to individual application components, see details below); and
• The PHS 398 standard page limit for Research Strategy is replaced by individual limits indicated below for the new subsections A-B.

In this section, describe the following aspects:

• The CTB, including its history, participating countries, and content of the CTB archive;
• The capacity of the CTB Coordinating Center to provide scientific oversight and facilitate research through scientific and administrative leadership with emphasis on coordination of efforts, efficient communications, and collaborations across multiple research institutions and countries;
• The capacity to create and manage relevant logistical infrastructures for specimen collection at the participating institutions;
• The capacity to facilitate the distribution of specimens to investigators with approved research access applications and to track specimen distribution consistent with the goals of the project;
• The capacity to establish and operate a centralized data collection, management, analysis, and dissemination core for the CTB;
• The capacity to create opportunities for disseminating research results to the scientific community;
• The capacity to assist the CTB Steering Committee in assembling appropriate advisory panels such as the Scientific Advisory Board, the Pathology Panel, and other relevant Working Groups, provide logistical and administrative support for the activities of the Steering Committee and its subcommittees and Working Groups, and facilitate and mediate communications between the NCI Program Official and other members of the Steering Committee to allow for efficient consultations and oversight of the project; and
• Major strengths and critical experience of the applicant.

In this section, summarize Progress to Date and milestones achieved during the previous funding period including the following:

• Objectives achieved by the project in coordinating the collection, storage, and processing of specimens and associated datasets at the collaborating institutions in the Chernobyl-affected countries;
• Objectives achieved by the project in coordinating the distribution of specimens to approved research projects;
• Objectives achieved for managing data and information on available CTB resources; and
• Scientific milestones accomplished and collaborations with the larger thyroid cancer research community.

Also in this section, and under a separate subheading, describe how the Coordinating Center will address the specific requirements and "Strategic Goals of the CTB to be Supported by the NCI" as defined in Section I. Funding Opportunity Description of this FOA. Specifically, describe the following aspects:

• Plans for achieving the proposed specific aims (including benchmarks for success);
• Plans for research data management; and
• The capacity of the CTB to enable its self-evaluation to promote effective self-correcting/self-improving actions.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:

• This application should address a Data Sharing Plan, including, if applicable, a GWAS Sharing Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

This application must be received on or before the due date in Part I. Overview Information. If the application is received after that date, it may not be reviewed.

Upon receipt, the application will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NCI, NIH. An application that is incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The emphasis of this FOA is on maximizing the potential and scientific value of the Chernobyl Tissue Bank as a unique international and collaborative research resource that aims to establish and maintain a collection of thyroid cancer specimens from patients who were exposed to radioiodine from the Chernobyl accident as children or young adults. The CTB Coordinating Center (subject of this limited competition FOA) is the key element essential to accomplishing this goal. Reviewers will assess the special opportunities presented by the CTB Coordinating Center infrastructure in addressing the goal of this FOA and furthering research on Chernobyl-related thyroid cancer.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA: How well will the Coordinating Center serve the strategic goals of the CTB? Are the research infrastructure, available resources, study populations, and institutional collaborations in place and adequate to support the overall objectives of the CTB? Given the availability to the project of specific resources and study populations at the collaborating institutions, what is the likelihood that the Coordinating Center, as proposed, will make a significant contribution in establishing a unique resource that can further research on Chernobyl-related thyroid cancers?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for this FOA: Are the expertise and commitment of the PD/PI and other key personnel adequate for the required scope and objectives of the CTB Coordinating Center and in line with the overall goals of the CTB? Has the PD/PI demonstrated sufficient leadership in coordinating tissue banking research across multiple institutions and countries?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific for this FOA: Given the multi-national and geographically spread nature of the CTB project, are the proposed approaches innovative in optimizing the research oversight and functions of the Coordinating Center?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA: Are the proposed functions and activities of the CTB to be supported by the NCI award (as defined in Part2. Section I of this FOA, under "Research Objectives and Specific Requirements for the CTB Coordinating Center") well described and adequate to sustain the strategic goals of the CTB?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific for this FOA: Is the environment of the awardee institution adequate and can it support the Coordinating Center in accomplishing its goal of managing CTB research across multiple institutions and countries?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

The committee will consider the progress made in the last funding period. .

Revisions

Not Applicable..

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources..

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Groupconvened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Application will be assigned to the NCI. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardee is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared among the awardee and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD/PI will have the primary responsibility for defining objectives and approaches, and for planning, conducting, analyzing, and publishing results, interpretations, and conclusions from the project. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research in accordance with terms and conditions of the award.

Specific activities include:

• Planning, coordinating, and overseeing the performance of research approaches and procedures for the collection, storage, processing, and dissemination of biospecimens and associated datasets at the collaborating institutions in the Chernobyl-affected countries;
• Maintaining Institutional Review Board/Ethics committee approvals and the Office for Human Research Protections Assurance of Compliance at all the participating sites in the project;
• Posting and releasing data and information on available resources according to the approved plans for timely sharing of research resources and data generated through the award, as agreed upon by the CTB Steering Committee and the NCI Program Official;
• Serving on and facilitating the functions of the CTB Steering Committee and CTB advisory subcommittees including the Scientific Advisory Board, the Pathology Panel, and other appropriate Working Groups (for details, see Section VI. 2. Under "Terms and Conditions of Cooperative Agreement);
• Coordinating and organizing the meetings of the Steering Committee and the advisory subcommittees as scheduled;
• Cooperating in the program evaluation process as called upon by the NCI Program Official and the CTB Steering Committee;
• Accepting and implementing all scientific and policy decisions approved by the CTB Steering Committee to the extent consistent with applicable grant regulations;
• Providing information to the NCI Program Official concerning progress by submitting annual progress report in a standard format; and
• Providing information to the NCI Program Official concerning the CTB Steering Committee and advisory subcommittees meetings and their outcomes.

The Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A designated NCI Program Director, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. NCI Project Scientist will not attend peer review meetings of renewal and/or supplemental applications. If such participation is essential, this individual will seek NCI waiver according to the NCI procedures for management of conflict of interest.

In addition, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice. If this individual becomes substantially involved in the CTB activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NCI waiver if such participation is essential.

The primary NCI programatic responsibilities to the CTB include:

• Maintaining substantial programmatic involvement in the development of the project;
• Serving as the responsible official for the usual scientific and programmatic stewardship of the award;
• Serving as the NCI representative and voting member to the CTB Steering Committee (for details see Section VI. 2. Under "Terms and Conditions of Cooperative Agreement);
• Cooperating with the international partners that participate in the project;
• Assisting in promoting and coordinating scientific collaborations with the CTB;
• Monitoring the performance of the CTB and making recommendations to the Steering Committee and NCI on the overall direction of the project and allocation of funds;
• Reviewing the progress of the project;
• Serving as a liaison in stimulating a broader interactions between the CTB and other NCI and NIH programs to disseminate results from the CTB and leverage existing NIH/NCI resources and infrastructures;
• Evaluating the adherence of the CTB awardee to the approved resource sharing plan; and
• Coordinating an external evaluation of the CTB project.

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to the CTB awardee institution if it is unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

Areas of Joint Responsibility include the following:

The CTB Steering Committee will serve as the main governing board for the CTB project.

The committee will consist of the following voting members:

• One senior representative from each international funding agency that collaborate on the project;
• The Directors, or their representatives when appropriate, of the institutions in the Chernobyl-affected countries that participate in the project;
• The Principal Investigator of the CTB project and the project manager who together have one vote.

The CTB Steering Committee will meet one time per year in a face-to-face meeting. A chair of the CTB Steering Committee will be selected for every 12 months by the committee to coordinate its operation.

Additional non-voting members to serve in an advisory capacity may be added to the CTB Steering Committee as needed by a decision of the existing voting committee members.

The CTB Steering Committee will have primary responsibility for:

• Overseeing the overall direction of the CTB project and reviewing its progress and research goals;
• Reviewing and approving memberships and activities of the advisory subcommittees including the Scientific Advisory Board and the Pathology Panel;
• Ensuring the continued presence of appropriate scientific expertise on the advisory subcommittees to promote the exchange of knowledge and ideas within the project and to ensure its continued advancement;
• Reviewing the potential of shared infrastructure(s) at the participating institutions that will serve the needs of the project;
• Ensuring that the project takes advantage of existing resources such as those present at the NIH and NCI; and
• Serving as arbitrator of any issue or concern that could arise.

The CTB Steering Committee will maintain the Scientific Advisory Board that will advise the Steering Committee and the awardee. The Scientific Advisory Board will be comprised of scientific experts in various topics that are relevant to the project and charged with the following activities:

• Reviewing once-a-year the overall progress of the CTB and providing its recommendations to the Steering Committee and the awardee;
• Advising the CTB regarding scientific development in the field; and
• Developing and recommending to the Steering Committee criteria for the evaluation of the CTB.

The CTB awardee will be required to accept and implement policies approved by the CTB Steering Committee.

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between the award recipient and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardees right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from eligible applicant.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Rihab Yassin, Ph.D.
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard, MSC 7393
Bethesda, MD 20892-7393
Telephone: (301) 496-7028
E-mail: [email protected]

Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Blvd, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for US Postal Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
Telephone: 301-496-8634
e-mail: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.