It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) 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. 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 the 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 limited competition Funding Opportunity Announcement (FOA) solicits the renewal application for the Chernobyl Tissue Bank (CTB) Coordinating Center. The CTB is a collaborative resource that is supported by the NCI and another international partner and includes active participation of countries critically affected by the Chernobyl nuclear power plant accident. The objective 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 the critical component that serves this goal and functions to lead, plan, integrate, and achieve the stated research objectives in collaboration with the participating institutions in the Chernobyl-affected countries. The Coordinating Center also maintains CTB communications, data core, and bioinformatics. Details regarding the structure and collaborative support for the CTB are found at http://www.chernobyltissuebank.com. 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.

Chernobyl Late Health Effects. Approximately 5 years after the Chernobyl accident, a significant increase in pediatric thyroid cancer cases was reported in areas of Belarus, Russia, and Ukraine. International reports and studies have concluded that more than 5000 cases of thyroid cancer, mainly in children and adolescents at the time of the accident, 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 the populations exposed to Chernobyl but their possible association with radiation exposure is still being assessed.

The Chernobyl Tissue Bank. The CTB is an international resource that is currently supported by the NCI in collaboration with the Sasakawa Memorial Health Foundation of Japan. The project involves active participation of Ukraine and Russia as two of the countries critically affected by the Chernobyl accident. The objective of the CTB is to maintain a research resource that supports studies on the biology of radiogenic thyroid cancer. The CTB was established in 1998 following evidence of increases in pediatric thyroid cancer in the Chernobyl-affected populations. The incidence of thyroid cancer in children is normally very low but its sudden increase in the areas that were exposed to Chernobyl fallout necessitated research efforts on the biology of radiogenic thyroid cancer. Addressing this research required the availability of high quality thyroid cancer specimens that were meticulously and ethically collected.

The CTB collects specimens from patients who were aged 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 December 1, 1986, who represent a closely matched cohort (by age and residency). This cohort has not been exposed to the radioiodine fallout but has developed sporadic thyroid cancer at a young age. Only specimens that are in excess to the patient’s diagnostic and therapeutic needs are collected by the CTB. The resource does not normally provide thyroid tissues to researchers, only tissue sections and extracted bioanalytes in order to preserve these rare specimens for comprehensive scientific investigations.

The CTB has been successful in acquiring thyroid cancer cases from areas that were affected by radiation from the Chernobyl accident. To date, approximately 5222 cases have been collected and reviewed by the Pathology Panel and of these, 4500 cases from Ukraine and Russia are available for research. Information on the number and type of cases in the CTB archive is available on the CTB website (www.chernobyltissuebank.com). Access to the CTB is available by application following review and concurrence by the External Review Panel and the CTB Steering Committee, respectively.

The CTB has established itself as an important model for research on the biology of thyroid cancer through scientific leadership and methodical research approaches. This system has 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 combine research data from its samples with clinical information will further advance investigations on the biology of thyroid cancer.

Current CTB Structure and Management. The CTB is coordinated and administrated by the Coordinating Center located at Imperial College, London, United Kingdom. The collection of biological specimens is led by the Institute of Endocrinology and Metabolism in Kiev, Ukraine, and the Medical Radiological Research Center in Obninsk, Russia. These institutions collect, document, and store consented specimens and the clinical-pathological data on each patient. The participating institutions also process specimens and perform extraction of bioanalytes for approved research projects.

The CTB is overseen by the Steering Committee, which is composed of senior representatives from the funding agencies and the participating institutions in Ukraine and Russia. An independent virtual Scientific Advisory Board of international experts in various scientific disciplines advises the CTB Steering Committee and the Program Director/Principal Investigator (PD/PI) on progress in relevant research areas. A Pathology Panel composed of internationally-renowned thyroid pathology experts provides consensus diagnosis on each case included in the CTB database.

Strategic Goals of the CTB to be Supported by the NCI

The CTB Coordinating Center must meet the following research objectives and specific requirements (for additional details on the requirements, please see Section IV. Application and Submission Information):

(A) Overall Role of the CTB Coordinating Center. The CTB Coordinating Center should have a key role in promoting research on the biology of Chernobyl-related thyroid cancer. The CTB Coordinating Center must fulfill this role through providing scientific, administrative, and logistical support for the collection, storage and processing of specimens at the participating institutions in the Chernobyl-affected countries as well as facilitating access to these specimens for approved research projects. The CTB Coordinating Center must be able to connect and integrate activities and resources at all the participating sites/countries and serve as the effective management hub of the CTB.

(B) CTB Leadership and Outreach. The CTB Coordinating Center must demonstrate strong leadership and expertise in coordinating a complicated multi-site tissue banking program, and provide infrastructure that supports the statutory scientific activities of the CTB and achieves its objectives. This infrastructure must allow for successful partnerships with the participating institutions, facilitation of the scientific functions of the CTB Steering Committee and its subcommittees, and collaboration with the NCI and global thyroid research community. The CTB Coordinating Center is expected to have a significant responsibility in ensuring its continued self-evaluation and improvement.

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.

Governance of the CTB

The CTB will be governed by the Steering Committee. Details regarding the composition and function of the CTB Steering Committee are provided in Section VI.2 Administrative and National Policy Requirements-Cooperative Agreement Terms and Conditions of Award.

See Section VIII. Other Information for award authorities and regulations.

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.

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

This is a limited competition FOA. Only the current CTB Coordinating Center awardee institution 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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements:

For this FOA, the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Describe the overall specific aims of the CTB Coordinating Center and its scientific focus.

Research Strategy: Describe the Research Strategy consisting of the following sub-sections A-B (as outlined below). The sub-sections must detail how the CTB Coordinating Center plans to address the strategic goals to be supported by the NCI (considering benchmarks for success).

Sub-section A. Overall Role of the CTB Coordinating Center. In this section, describe the following, including progress to date and milestones achieved during the previous funding period:

• The organization and vision of the CTB, comprising the participating institutions and content of the specimen archive;
• The capacity of the CTB Coordinating Center for providing scientific oversight and facilitating specimen collection and distribution while emphasizing coordination of efforts, efficient communications, and collaborations across multiple research institutions and countries. This includes, but is not limited to, the following functions:
• Creating and managing relevant logistical infrastructures and obtaining agreements from the participating institutions in the Chernobyl-affected countries;
• Implementing and managing sub-contractual arrangements with the participating institutions;
• Facilitating the timely distribution of specimens to investigators with approved research access applications and tracking specimen distribution consistent with the goals of the resource; and
• Establishing and operating a centralized data collection, management, analysis, and dissemination core for the CTB (data warehouse).

Sub-section B. CTB Leadership and Outreach. In this section, describe the following:

• The leadership structure of the Coordinating Center and its collaborators at the participating institutions that can support the statutory scientific activities of the CTB and achieve its objectives. This includes major strengths and the critical collective experiences of theresearch team in the proposed scientific areas (explain collective strengths without repeating information from the biosketches) and the strengths of their institutional environments (e.g., academic or other research);
• The capacity of the Coordinating Center for supporting the scientific functions of the CTB Steering Committee and its subcommittees, assembling appropriate advisory subcommittees such as the Pathology Panel and other relevant Work Group(s), and facilitating and mediating communications between the NCI Program Official and other members of the Steering Committee to permit efficient consultations and oversight of the resource;
• The capacity to organize the annual Steering Committee meeting (in collaboration with the NCI Project Scientist);
• The capacity and plans to create opportunities for dissemination of research results from the accessed specimens to the scientific community;
• Plans for scientific outreach efforts, including workshops and collaborations with the global thyroid cancer research community; and
• The approach to 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 as provided in the SF424 (R&R) Application Guide, with the following modification:

• The application, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• The plan should include sharing of genomic data (to the extent applicable).

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 furthering research on Chernobyl-related thyroid cancer by maximizing the potential and scientific value of the Chernobyl Tissue Bank as a unique international and collaborative research resource.

Reviewers will provide an overall impact 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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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 to advance research on Chernobyl-related thyroid cancer? Given the availability 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 sustaining the CTB as a unique research resource?

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 or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for this FOA: Based on the past performance, has the PD/PI demonstrated sufficiently strong leadership and skills in coordinating tissue banking research across multiple institutions and countries?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific for this FOA: Are the proposed functions and activities of the Coordinating Center to be supported by the NCI award clearly defined and adequate to sustain the strategic goals of the CTB? Given the multi-national and geographically spread nature of the CTB project, can the proposed approaches be effective in optimizing the research oversight and functions of the Coordinating Center? Are the research infrastructure, available resources, study populations, and institutional collaborations in place and adequate to support the overall objectives of the CTB?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 functions 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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period.

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 score.

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.

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.
• Appeals of initial peer review will not be accepted for the application submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

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:

• Overseeing all the functions of the CTB Coordinating Center;
• Defining research objectives and approaches;
• Supervising research planning and conduct, including data analysis, interpretation, conclusion, and publication of the resulting findings;
• Assuming 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 approaches and procedures for the collection, storage, processing, and dissemination of specimens and associated data at the collaborating institutions in the Chernobyl-affected countries;
• Securing and maintaining Institutional Review Board/Ethics Committee approval and the Office for Human Research Protections Assurance of Compliance at all the sites participating in the resource;
• Posting and releasing data and information on available specimens and other 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 its subcommittees (but not as a chair);
• Coordinating and organizing the meetings of the Steering Committee and its subcommittees as scheduled;
• 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 the CTB Steering Committee and its subcommittees meetings and their outcomes;
• Adhering to the NCI best practices for biospecimen resources;
• Cooperating in the resource evaluation process as called upon by the NCI Program Official; and
• Providing information to the NCI Program Official concerning progress by submitting annual Research Performance Progress Report.

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. 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.

The NCI Project Scientist will have the following responsibilities:

• Maintaining substantial programmatic involvement in the progression of the resource;
• Serving as the NCI representative and voting member of the CTB Steering Committee;
• Collaborating with the international partners that participate in the resource;
• Assisting in promoting and coordinating national and international scientific collaborations with the CTB;
• Monitoring the performance of the CTB and making recommendations to the CTB Steering Committee and NCI on its overall direction, priority areas, and allocation of funds;
• Reviewing the progress of the resource;
• Serving as a liaison in stimulating 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 as appropriate; and
• Coordinating an external evaluation of the CTB.

The NCI reserves the right to adjust funding, withhold, suspend, or phase out the support to the awardee if the team is unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly lower the level of performance.

Areas of Joint Responsibility include:

The CTB Steering Committee will serve as the main governing board of the CTB. The committee will consist of the following voting members:

• The NCI Project Scientist;
• One senior representative from the international funding agency that collaborate on the project;
• The Directors, or their representatives when appropriate, of the participating institutions in the Chernobyl-affected countries;
• The PD/PI of the CTB Coordinating Center 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 by the committee to coordinate its operation (the PD/PI of the CTB Coordinating Center will not serve as a chair).

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 following primary responsibilities:

• Overseeing the overall strategic direction of the CTB;
• Reviewing the CTB progress and research goals annually and as needed;
• Reviewing and approving memberships and activities of the advisory subcommittees and Work Group(s);
• Ensuring the availability 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 resource;
• Ensuring that the resource 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 a 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.

External Evaluation of the CTB

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. A particular focus area will be the improved understanding of thyroid carcinogenesis. The evaluation will entail the quality and innovation of the overall CTB approaches as well as the status of its archive, infrastructure, and timely access by the research community to CTB specimens and data. The relevant measures of success will be identified from the context presented above and from other scientific evidence.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Rihab Yassin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6230
Email: ry38k@nih.gov

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276--6291
Email: hines@mail.nih.gov

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 Part 75.