Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (UM1)
Activity Code	UM1 Multi-Component Research Project Cooperative Agreements
Announcement Type	Reissue of PAR-10-283
Related Notices	March 19, 2014 - This PAR has been reissued as PAR-14-160.
Funding Opportunity Announcement (FOA) Number	PAR-11-167
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393, 93.394, 93.396, 93.397
FOA Purpose	This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), invites grant applications to provide targeted infrastructure support for the core functions of Cancer Epidemiology Cohorts (CECs) and methodological research. This infrastructure can support existing or new CECs. This FOA will support core functions for CECs currently funded through other grant mechanisms by the Epidemiology and Genetics Program (EGRP) and other components of the Division of Cancer Control and Population Sciences (DCCPS) at the National Cancer Institute (NCI).

Posted Date	March 17, 2011
Letter of Intent Due Date	June 6, 2011, October 10, 2011, February 6, 2012, June 6, 2012, October 8, 2012, February 8, 2013, June 10, 2013, October 8, 2013
Application Due Date(s)	July 6, 2011, November 10, 2011, March 6, 2012, July 6, 2012, November 8, 2012, March 8, 2013, July 10, 2013, November 8, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2011; February/March 2012; June/July 2012; October/November 2012; February/March 2013; June/July 2013; October/November 2013; February/March 2014
Advisory Council Review	January 2012; May 2012; October 2012; January 2013; May 2013; October 2013; January 2014; May 2014
Earliest Start Date(s)	April 2012; July 2012; December 2012; April 2013; July 2013; December 2013; April 2014; July 2014
Expiration Date	November 9, 2013
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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH s Applying Electronically website.

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

Purpose

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), invites grant applications to provide targeted infrastructure support for the core functions of Cancer Epidemiology Cohorts (CECs) and methodological research. This infrastructure can serve either the continuation of an existing CEC or the establishment of a new CEC. This FOA will support core functions for CECs currently funded through other grant mechanisms. This FOA should be used for all requests for support to continue existing CECs or to establish new CECs.

Background

Classic CECs are organized for large observational human population studies in which groups of people with a set of characteristics or exposures are followed systematically and prospectively for the incidence of new cancers, cancer mortality, and/or cancer-related outcomes. This definition includes large cohorts of cancer patients in observational studies involving responses to therapies and short- and long-term health outcomes occurring after diagnosis. Throughout the last two decades, CEC-based studies have helped to better understand the complex etiology of cancer and have provided fundamental insights into key environmental, lifestyle, and genetic determinants of this disease. Findings from CECs are critical for risk prediction analyses and models. These findings may also serve as a basis for cancer control measures for groups and populations at risk. Evidence generated by CECs has also been useful in providing the basis for the design and testing of many preventive and therapeutic interventions. Large biorepositories established by CECs already support genomic and epigenetic studies, and are beginning to support proteomic and metabolomic studies. Further, CECs are essential to genome-wide association studies (GWAS) and replication and/or expansion of prior GWAS findings that have led and will lead to the identification of putative cancer susceptibility loci of low penetrance and high frequency, and will potentially lead to the identification of genes associated with prognosis and survival for a variety of cancers. As the genes present in these loci are identified and their functions are clarified, the prospective exposure data accumulated from CECs afford opportunities for in-depth analyses of gene-environment interactions, which will be critical for the design of public health interventions. NCI recognizes that CECs are valuable resources that benefit the entire cancer research community and, that in order to be successful as a population sciences research resource, CECs need to accrue large and varied population samples and continue to follow-up with study participants over an extended period of time.

Types of Qualifying Cancer Cohorts. Support is envisioned for two types of CECs through this FOA:

1) CECs with at least 10,000 study participants that are capable of supporting studies to examine the effects of multiple exposures and study participants characteristics on the risk of multiple types of incident cancers and cancer mortality; and

2) cohorts of cancer patients including at least 10,000 participants for research addressing determinants of cancer prognosis, progression, and cancer-related outcomes among cancer survivors such as cancer recurrence, development of new primaries, survival, and health conditions and chronic diseases related to the cancer, cancer-directed therapy, or its consequences.

This FOA should be used for all requests for support to continue existing CECs or to establish new CECs.

Cohorts established to assess the role of exposures in the workplace on risk of cancer (i.e., occupational cohorts ) may be appropriate for this FOA, but only if they were established to examine a broad range of exposures potentially experienced by the general public and/or genomic factors affecting cancer risk or outcomes after cancer diagnosis. Cohorts focusing primarily on cancer risks associated with exposures in the workplace are not appropriate for this FOA.

This FOA is intended to support cohorts established to identify factors that increase or decrease the risk of developing cancer or the incidence of health outcomes after cancer. Therefore, cancer surveillance activities and development and maintenance of registries of persons with particular characteristics that do not address identification of factors increasing or decreasing risk are not appropriate for this FOA.

Scope of the FOA. The activities to be supported by this FOA include the establishment, maintenance, or upgrade of CECs core functions such as recruitment, retention, and biospecimen collection. Methodological research to validate or evaluate new or existing approaches to core infrastructure functions is also appropriate. Specific core functions that can be supported for the existing or newly proposed cohorts include, but are not limited to:

• Ongoing or new accrual of the target population, and enrollment of special populations in the catchment area;
• Follow-up (active and passive) of enrolled participants;
• Systematic, high-throughput assessment of genetic or other biological markers when required to interpret new research findings and when these markers are not already available on all relevant cohort study subjects (e.g., tumor hormone receptor status);
• Validation, quality control, standardization, harmonization, and/or calibration of data across cohorts; biospecimen collection and management; and
• Data management and data sharing activities, and administrative and communication tasks.

Methodologic research may include, but is not limited to research investigating the following:

• Improved approaches to the systematic, high-throughput assessment of genetic or other biological markers;
• Validation of exposures and health outcomes, for example, the quality of self-reported data versus medical record information, or assessment of how well a biomarker measured through non-invasive means compares to that measured in an appropriate target tissue;
• Development and improvement of quality control (QC) and quality assurance activities related to laboratory work, data use, biospecimens, etc.;
• Methods for biospecimen collection and management;
• Virtual tissue repositories with metadata about available tissues across cohorts and connections to pathologic tissue image libraries.
• Applicants responding to this FOA are expected to focus on activities that will: enable efficient planning and operation of cohorts; maximize their potential to respond to future scientific needs; enable the CECs to address cutting-edge research questions related to cancer susceptibility in human populations; and facilitate scientific collaborations across cohorts.

Note: Research projects relying on the CECs infrastructure are NOT appropriate for this FOA. As in the past, such projects are expected to seek support through appropriate research project mechanisms (such as investigator-initiated R01 and P01 grants).

Consolidation of CEC Support. Currently, core functions of a CEC may be supported by multiple research project grants. This fragmented support is not optimal (e.g., individual research project grants may have only partially overlapping funding periods). This FOA allows for the fragmented infrastructure components of a CEC to be consolidated under a single cooperative agreement (UM1) award.

The transition to the consolidated infrastructure support may be initiated, for example, when a grant(s) that contains core infrastructure components becomes eligible for renewal. If the application is selected for funding, the overlap with other grants will be administratively adjusted.

As the awards under this FOA will use the cooperative agreement mechanism, the implementation will involve substantial involvement of NCI program staff members in various activities that are relevant to all CECs, such as data harmonization, facilitation of multi-CEC scientific opportunities, biospecimen resources optimization, and systematic assessment of molecular markers.

During the lifetime of the CEC, NCI staff will assess yearly progress toward achievement of the yearly milestones described in the application. Achievement of these milestones will be evaluated by NCI prior to releasing funding for each year of the award.

Informatics. Respondents to this FOA will be required to provide and regularly update metadata about their cohort to NCI including cohort characteristics, study protocols, basic counts of study participants with various characteristics such as biospecimen availability and study variable definitions. Investigators will be expected to evaluate and document consistency of their resources across biospecimen resources, for example, consistent with NCI’s Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/bestpractices) for collection, processing, and storage of future and past biospecimens.

NCI will compile metadata across cohorts and make the information available online to assist the research community in identifying potential cohorts to address specific research questions or evaluate the potential for cross-cohort studies.

Respondents to this FOA will be expected to explore the feasibility of cross-CEC data harmonization with NCI staff and other awardees through participation in working groups, consistent with the goals of this program.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Resubmission The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	A project duration of up to 5 years may be requested.

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.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Foreign (non-U.S.) components on applications submitted by U.S. Organizations 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 Directors/Principal Investigators (PD/PIs) 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 least four (4) weeks prior to the application due date.

Any individual(s) with 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 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 PHS398 Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct ( i.e., pertains to a different cohort).

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Daniela Seminara, Ph.D., M.P.H.
Senior Scientist and Consortia Coordinator
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
9609 Medical Center Drive, Room 4E130
Bethesda, MD 20892-9763 (for regular mail)
Rockville, MD 20850 (for express delivery)
Telephone: 240-276-6748
E-mail: [email protected]

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
9609 Medical Center Drive, Room 7W412
Bethesda, Maryland 20892-9750 (for Express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: [email protected]

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• Research Strategy section is limited to 30 pages.

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

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to include in Section 3 Research Strategy the following new sub-sections A C:

A. Program (Cohort) Overview

B. Infrastructure Design and Research Program

C. Leadership and Administrative Core

RESEARCH STRATEGY:

Research Strategy should consist of the the following sub-sections A C:

A. Cohort Overview (up to 12 pages)

1. Background and Experience. Describe the group’s history and experience in designing and implementing CECs.

2. Progress (existing cohorts only). Include a progress report describing the CEC’s accomplishments relative to both infrastructure and supported research. Include a summary of accrual, data and biospecimen collection, and follow-up over the past project period, and a report describing compliance with the data sharing plan as originally proposed.

B. Infrastructure Design and Research Program (up to 12 pages)

• Cohort Infrastructure. The application should delineate its catchment area. A description of the study population in the application’s catchment area, with a breakdown by percentage of gender and racial/ethnic subpopulations, using categories described in http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm, should be provided. The CEC’s design and projected or known composition should be described in detail. Approaches and methods proposed for recruitment, follow-up, collection and management of biospecimens, high-throughput assays, data management, quality control, and internal data sharing policies should be described.
• Core Infrastructure Activities. Describe the planned activities related to the core functions described in Section 1 of this FOA.
• Organizational Structure. The application should describe the current and/or planned organizational structure under which the CEC proposes to operate. An organizational chart showing how the group will function should also be included. The availability of facilities, including laboratories, cancer registries, etc., should be described. A statement of commitment from each participating institution or organization (Note: Include letters of institutional commitment under 14. Letters of Support [e.g., Consultants] and/or documentation of consortium arrangements should be provided. Also include Letters of Intent to Establish a Consortium under Section 14 of Research Plan "Letters of Support". Applicants, whose applications are considered for funding, will have to provide fully executed consortium agreements as a Just-in-Time requirement). In addition, each application should have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication. The description of this space may be included under the Resources section or under Organizational Structure.
• Methodologic Research. The application should describe the group’s plans for methodologic research aimed at developing, testing, and validating new methods and approaches to improve the proposed cohort infrastructure.
• Broad Research Agenda. The application should describe the scientific rationale underpinning the need for the cohort and a broad research agenda the cohort will be designed to support in the short, medium, and long range.

C. Leadership and Administrative Core (up to 6 pages)

Key/Senior Personnel. The use of the multiple PDs/PIs option is encouraged. If this option is used, a designated contact PD/PI is required. A substitute lead PD/PI candidate should be identified to assure continuity in the event of resignation of the PD/PI. The qualifications and experience of both persons should be described, specifically documenting their respective abilities to organize and manage a CEC and related activities. In addition, the application should describe the strategy used by the PD/PI to delegate leadership responsibility and how the responsibility is distributed among key/senior investigators.

The qualifications, experience, and proposed duties of all proposed essential support personnel should be described.

Note: Other sections of the PHS 398 Research Plan remain unmodified and should be completed following standard instructions.

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (seehttp://grants.nih.gov/grants/funding/phs398/phs398.html).

All foreign applicants should complete and submit budget requests using the Research & Related Budget Component instructions found in the application package for this FOA. See NOT-OD-06-096.

Applicants may include in their proposed budgets the costs pertinent to the submission of metadata to NCI. Additionally, applicants may include costs expected for harmonizing data across cohorts and/or providing access to CEC data for studies requiring pooled data (these efforts will be conducted in cooperation with NCI).

Annual Meeting. Awardees under this FOA will be required to participate in an annual Investigators Meeting with NCI staff to maintain dialogue and communication and foster data sharing. This meeting may be concurrent with the NCI Cohort Consortium’s annual meeting to foster interaction among investigators involved in the maintenance of diverse cohorts, such as NCI’s intramurally funded CECs. Costs associated with key personnel attending this meeting should be included in the application’s budget. Application for membership in the NCI Cohort Consortium is also strongly encouraged because this is the main NCI-sponsored consortium implementing cross-cohort collaborative projects (see http://epi.grants.cancer.gov/Consortia/cohort.html).

Cooperative Agreement

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

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 modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data 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) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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.

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

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review . Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

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.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program 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 program 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 program that by its nature is not innovative may be essential to advance a field.

Significance

Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program 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?

In addition, specific to this FOA:

How likely it is that the program will be successful in achieving the overall scientific agenda that is proposed? How will the proposed core functions implementation improve the capability to address the cohort scientific agenda? For the continuing CECs, are the follow-up rates and/or response rates (especially the first round of follow-up) adequate? Are the length of follow-up and age characteristics of the cohort appropriate? Are the types and number of outcome variables tracked appropriate for the intended research scope? Is the CEC population representative or unique?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the program? 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?

In addition, specific to this FOA:

Is there evidence of the success of the cohort investigators in the past to support productive scientific projects (as measured by publications and related grants)? How successful has the applicant team been in completing previously proposed CEC’s aims and activities?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? 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 program 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?

In addition, specific to this FOA:

Are the plans to optimize the continuation or establishment of activities in support of the CEC adequate? How realistic are these plans in terms of achieving a high-quality support infrastructure? Are there appropriate plans for the rigorous management and quality control of data and biospecimens collected by the CEC? Are the CEC design and methods adequate to achieve the stated objectives and to support the stated overall research agenda? Are the CEC objectives described likely to be completed during the requested period? How adequate are the administrative and communication structures in terms of efficiently supporting the CEC’s activities?

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?

As applicable for the program 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 program 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made.

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the program 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 Group(s) , 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned to the NCI and will compete for available funds with all other recommended applications submitted in response to this FOA. 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.
• Programmatic priorities (e.g., the uniqueness of the CEC).

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 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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services 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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Defining objectives and approaches;
• Defining the research plan and goals;
• Overseeing the analyses and interpretation of studies conducted under this program as well as publication of their results;
• Overseeing/performing other scientific activities of the plan;
• Monitoring the completion of the supported activities and taking corrective actions if needed;
• Participating in the activities of the Program Steering Committee;
• Accepting and implementing the policies approved by the Program Steering Committee to the extent consistent with applicable grant regulations;
• Cooperating with NCI programmatic, technical, and administrative staff; and
• Administratively managing the UM1 award.

The PD(s)/PI(s) assumes(s) responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the UM1 award in accordance with these terms and conditions of the award.

Specific rights and responsibilities of awardees will include the following:

Awardees will be expected to evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources, for collection, processing, and storage of future and past biospecimens (http://biospecimens.cancer.gov/bestpractices).

Awardees will be required to explore with NCI staff and other awardees of this FOA the feasibility of pooling data across cohorts or providing access to the data from their cohort for studies requiring pooled data.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

A designated NCI Program Director(s) acting as a Project Scientist(s) will have the following responsibilities:

• Participating in the activities of the Program Steering Committee;
• Facilitating collaborations between the awardees and other NCI-sponsored programs, investigators, or organizations that may contribute to the projects goals;
• Serving as liaison between the research awardees and NCI staff members and investigators involved in the program, facilitating interactions and scientific integration between the UM1 awardees;
• Assisting in the interaction between the UM1 research awardees and investigators at other institutions, as appropriate for the program;
• Promoting collaborative research efforts that involve interactions with other NIH-supported projects, programs, and centers and helping with the coordination of such efforts;
• Participating in program meetings;
• Reviewing all major transitional changes that the awardees might propose (e.g., a change in partnering institution) and advising on their appropriateness prior to implementation to assure consistency with the goals of this FOA;
• Providing technical assistance and advice to the awardees as appropriate;
• Assisting in avoiding unwarranted duplication of effort with other NIH efforts;
• Monitoring institutional commitments and resources to the awardees;
• Reviewing the progress of individual awardees, as well as the entire Program;
• Monitoring the adherence of the awardees to the approved data sharing plans;
• Suggesting reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met;
• Recommending withholding of support, suspension, or termination of the award for insufficient progress and/or lack of adherence to required policies and/or procedures; and
• Organizing and conducting regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the awardees.

Additional NCI staff members may be designated to have substantial involvement. The substantially involved NCI staff members will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waivers according to the NCI procedures for management of conflict of interest.

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those awardee institutions that are 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 Steering Committee will serve as the main governing board for the CEC Core Functions and Methodological Research initiative.

The Steering Committee will consist of the following voting members:

• Two representatives of each awardee (the contact/lead PD/PI and a designated back up senior investigator), who will collectively have one vote; and
• Two NCI Project Scientists who will collectively have one vote for the NCI.

The appointed voting CEC members will be required to attend all the CEC Steering Committee (SC) meetings and teleconferences or to appoint a substitute that will be fully briefed on the issues at hand. Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members. Steering Committee may also formed subcommittees as needed. The NCI Project Scientist may serve on such subcommittees as deemed appropriate.The Chair of the Steering Committee will be selected from the SC voting members.

The Steering Committee will meet one time per year in a face-to-face meeting. The Steering Committee chair will meet with NCI Project Scientists one-time per month by telephone conference.

The Steering Committee will have primary responsibility for:

• Overseeing the overall organization of the CEC Core Functions and Methodological Research initiative;
• Establishing advisory committees and subcommittees as necessary;
• Providing guidance on scientific and infrastructural issues pertinent to the funded cohorts;
• Coordinating integration of CEC Core Functions and Methodological Research awardees regarding common issues and projects;
• Providing guidance, overseeing and coordinating the activities of individual awardees towards cross-cohorts data harmonization; and
• Contributing to the development of policies and processes pertinent to the CEC infrastructures.
• Provide integration with the NCI Cohort Consortium on common issues and projects.

CEC Core Functions and Methodological Research awardees will be required to accept and implement the policies approved by the SC to the extent consistent with applicable grant regulations.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 potential applicants.

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]

Daniela Seminara, Ph.D., M.P.H.
Division of Cancer Control and Population Sciences
National Cancer Institute
Telephone: 240-276-6748
E-mail: [email protected]

Referral Officer
Division of Extramural Activities
National Cancer Institute
Telephone: 240-276-6390
E-mail: [email protected]

Lan H. Nguyen
Office of Grants Administration
National Cancer Institute, NIH
Telephone: 301-631-3006
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.