Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	National Cancer Institute Program Project (P01) Applications
Activity Code	P01 Research Program Projects
Announcement Type	Reissue of PAR-09-025
Related Notices	August 7, 2013 - This PA has been expired and reissued as PAR-13-321.
Funding Opportunity Announcement (FOA) Number	PAR-12-005
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, 93.395, 93.396, 93.399
FOA Purpose	With this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications for investigator-initiated program project (P01) grants. Proposed program projects may address any of the broad areas of cancer research, including (but not limited to) cancer biology, cancer treatment, cancer diagnosis, cancer prevention, and cancer control. Basic, translational, clinical, and/or population-based studies in all of these research areas are appropriate. Each Program Project application must consist of at least three component projects. The component projects must share a common central theme, focus, and/or overall objective.

Posted Date	October 21, 2011
Letter of Intent Due Date	30 Days Prior to the Anticipated Application Due Date(s)
Application Due Date(s)	Standard dates apply
AIDS Application Due Date(s)	Standard dates apply
Scientific Merit Review	Standard dates apply.
Advisory Council Review	Standard dates apply.
Earliest Start Date(s)	Standard dates apply
Expiration Date	(Now Expired August 7, 2013 per issuance of PAR-13-321), Originally January 8, 2015
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

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), invites grant applications for investigator-initiated Program Projects (P01) in any area of cancer research. P01 grants support integrated, multiproject research programs involving a number of independent investigators who share knowledge and common resources while working towards a unifying overall scientific goal. Therefore, every P01 program project proposed should have a well-defined unifying research theme.

Each Program Project application must include at least three component projects. The individual projects may represent several disciplines and/or address several discrete research aspects pertinent to one or more disciplines. However, all of the projects must be relevant to the common unifying central theme, focus, and the overall objective of the entire program project. Each individual project should reflect a self-standing scientifically meritorious research effort. In addition, however, the individual projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately.

This FOA invites multidisciplinary coordinated research programs in any of the broad areas of cancer research, including but not limited to studies of cancer biology, cancer treatment, cancer diagnosis, cancer prevention, and cancer control. Basic, translational, clinical, and/or population-based studies in all of these research areas are appropriate.

Minimum Number of Research Projects (Required): Each P01 application submitted in response to this FOA must include at least three related research projects. The projects must share a common central theme, focus, and/or overall objective.

Shared Resource Core(s) (optional): In addition to individual research projects, applicants may propose one or more Shared Resource Cores if needed for the proposed research. Both administrative and research support cores are allowed. Each Shared Resource Core must provide support and enhance the productivity, cost-effectiveness, and/or research outcome of at least two of the proposed research projects. New cores may be proposed and/or existing cores may be augmented to support the proposed research.

Multiple Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)): The NCI encourages P01 program project applicants to take advantage of the multiple PD(s)/PI(s) option. The use of this option allows, for example, the designation of any (or all) of the leaders of the individual projects or cores as a PD(s)/PI(s) of the overall application. If this option is used, it is expected that one of the PD(s)/PI(s) will be identified as the lead PD(s)/PI(s) who will be responsible for coordinating the entire program project.

See the NCI P01 Guidelines at http://deainfo.nci.nih.gov/awards/P01.pdf for more details about NCI P01 applications.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission Revision 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	Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary..
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 5 years.

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

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
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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

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

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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(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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) 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.

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:

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

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 identical, single-sided copies of the original applicationand all of the CDs with Appendix materials must be sent to:

Referral Officer
Program Coordination and Referral Branch
Office of Referral, Review, and Program Coordination
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

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:

• Overall Aims:1 page
• Overall Research Strategy: 12 pages:
• Program Integration and Mangement: 6 pages
• Overall Program Environment: no page limit, but be concise
• For each proposed Research Project
  • Title Page(on plain paper, not Form Page 1 in the PHS 398 form): 1 page
  • Specific Aims: 1 page
  • Research Strategy: 12 pages
• For each proposed Shared Resource Core
  • Title Page (on plain paper, not Form Page 1 in the PHS 398 form: 1 page
  • Specific Aims: 1 page
  • Core Services Plan: 12 pages

For Resubmission or Revision applications, also include the following:

Introduction (required for a resubmission or revision application)

• For Overall P01: 1 page
• For Each Research Project: 1 page
• For Each Shared Resource Core: 1 page

For all P01 applications submitted in response to this FOA, the standard PHS 398 instructions are modified as summarized below, and as described in more detail in the Guidelines for NCI P01s (go to http://deainfo.nci.nih.gov/awards/P01.pdf for SPECIAL INSTRUCTIONS for PREPARATION of PROGRAM PROJECT APPLICATIONS). These additional instructions are required because the PHS Form 398 is designed primarily for individual freestanding research grant applications, and does not have specific instructions for multi-project applications.

• Form Page 1 - Face Page: Include the number and title of this FOA in item/line 2 of the PHS 398 application face page.
• Form Page 2 - Description, Performance Sites, and Key Personnel: Under Description, state the proposed programs broad, long-term objectives, specific aims, and the significance to the field of cancer research. Define the relevance of each proposed project and shared resource core to the overall theme and goals of the program. List all performance sites and all Key Personnel and Other Significant Contributors for the entire P01, beginning with the PD(s)/PI(s) and then listing all other Key Personnel alphabetically. Include all project and core leaders, co-leaders, co-investigators, and consultants and consortium collaborators (if applicable and if these individuals will devote measurable effort to the project).
• Form Page 3 - Table of Contents: Modify the PHS 398 Form Page 3 to enable reviewers to find each component of the application easily. A sample Table of Contents is included as Appendix A in the Guidelines for NCI P01s as an example of the format for the Table of Contents and how the application should be organized (see http://deainfo.nci.nih.gov/awards/P01.pdf).
• Form Pages 4 and 5 Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of Support: Prepare a detailed composite budget for all requested support categories for the first years using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. If applicable, provide additional budget pages pertaining to Consortium/Contractual arrangements (following the standard PHS 398 instructions).
• Biographical Sketches: Compile all biographical sketches after the Overall Budget, starting with the PD(s)/PI(s) followed by all other investigators in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resources cores.

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

Overall Aims:

Summarize the overall theme, goals, specific aims and expected impact of the proposed program on one or more broad fields of cancer research (limited to one page).

Overall Research Strategy:

Summarize the overall research strategy, including the overall significance, innovation, approaches, preliminary studies and progress (for competing renewal applications) of the program as a whole. This section is limited to 12 pages excluding references and the list of publications that resulted from work in the program during the current funding period (for renewal applications).

Additional details on the content of the Program Overview section are provided in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf)

Program Integration and Management:

Explain how the proposed projects and shared resource cores (if proposed) will be coordinated and work together to address the overall goals and aims of the program more effectively than if the projects were done independently. Explain the plans for organizational and administrative management of the overall program, and for coordination and communication within the program. Explain the methods that will be used for monitoring progress in the projects and effective use of the shared resource cores. This section is limited to six pages.

Additional details on the content of the Program Integration and Management section are provided in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf)

Overall Program Environment:

The Overall Program Environment section should briefly summarize the overall institutional environment, resources and commitments that are relevant to effective implementation of the P01. Describe how the proposed projects and shared resource cores will use the facilities and resources available at the overall program level. Describe how the program as a whole will benefit from any special equipment, laboratories, patient populations, and collaborations.

Additional details on the content of the Overall Program Environment section are provided in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf).

Multiple PI Leadership Plan (if applicable). If the multiple PD(s)/PI(s) option is used, the required section describing the Multiple PI Leadership Plan (see SPECIAL INSTRUCTIONS below) should be inserted in the application after the Overall Program Environment section. There is no page limit for this section, but applicants should be specific and concise.

Individual Research Projects: Each P01 program project application must include at least three individual (albeit connected) research projects each of which is pertinent to the central theme of the program. Each research project should be prepared according to the standard PHS 398 instructions as modified in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf). Instead of the standard PHS 398 face page for each project, create a title page that lists the project number, the name of the project, and the name of the project leader. Do not repeat biographical sketches included at the beginning of the application. Do not exceed 12 pages for Section 3, Research Strategy, of the research plan. Each Project must have a single designated Project Leader.

Shared Resource Cores: Applicants may propose one or more (as needed) appropriate shared technical or administrative shared resources, cores. These shared resources must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested). Each shared resource core should be prepared according to the standard PHS 398 instructions as modified in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf)/ Instead of the standard PHS 398 face page for each shared resource core, create a title page that lists the shared resource core number, the name of the shared resource core and the name of the shared resource core director. Do not repeat biographical sketches included at the beginning of the application. Do not exceed 12 pages for Item 3, Core Services Plan, of each core. Each shared resource core must have a single designated Core Director

Resource Sharing Plan

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

• 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, with the following modifications:

• All paper PHS 398 applications submitted must provide appendix material on CDs only. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
• Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
• Submit the CDs with all appendix materials in the package with the two copies of the application that are sent to the NCI Referral Office.

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, NIH. 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, with the following modification:

• News of IND approval by FDA may be submitted along with news of articles accepted for publication.

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. 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 as a whole 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 program change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)/Overall Program Leadership: Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program? If the program is collaborative, or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are the leadership plan, governance and organizational structure appropriate for the program? Are the qualifications of the PD(s)/PI(s) and other senior scientists appropriate to coordinate all P01 activities? Do they provide effective scientific and administrative leadership, as demonstrated by selection of individual projects for scientific excellence and thematic relatedness? Is the commitment (percent effort) of the PD(s)/PI(s) and other senior investigators adequate?

Innovation: Does the overall program 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: Is the overall design of the P01, including strategies, methodologies and analyses, well-reasoned and appropriate to accomplish the specific aims of the program? What is the overall quality and potential influence of the component projects on the field(s) involved, and are the services provided by the shared resource cores (if proposed) adequate to support the program?

If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) the 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?

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? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of sufficient institutional support for the Program Project?

Integration: Is there evidence of scientific and administrative integration of the proposed Program? Is there evidence of coordination, interrelationships, and synergy among the individual research projects and core components? Are there clear advantages or value added by conducting the proposed research as a Program Project rather than through separate research efforts? For competing renewal applications, is there evidence of productive collaborations during the current funding period?

In addition to the standard NIH-wide criteria, the following criteria will be used to evaluate specific aspects/components of the P01 application.

For each proposed project, reviewers will provide an impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved. Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. The impact/priority score for each project will take into consideration these scored review criteria and any applicable Additional Review Criteria (listed below). A project does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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

Investigator(s): Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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?

Innovation: Does the project 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 project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) Protections for Human Subjects, 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?

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?

Each Shared Resource Core must provide essential functions or services for at least two projects. The merit of each shared resource core will be assessed based on the following criteria:

• Is the proposed Shared Resource Core well matched to the needs of the overall program? Does it provide essential facilities or services for two or more scored research projects?
• What is the overall quality of the proposed core services? Are there adequate quality control processes proposed for the facilities or services provided by the Shared Resource Cores (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage of Core products and/or services?
• Are the qualifications, experience, and commitment of the Shared Resource Core Director(s) and other key personnel adequate and appropriate for providing the proposed facilities or services?
• Will the proposed shared resource core(s) provide cost effective services to the Program? Are there adequate plans to augment and/or complement an existing shared resource supported by an NCI Cancer Center Support grant (P30), if applicable?
• Is the environment for the shared resource core adequate to support the program as proposed?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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 any changes made to the program.

Renewals

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

• Has adequate progress been made in both projects and shared resource cores since the previous competitive review?
• Were the previous specific aims accomplished, and are the proposed research goals logical extensions of work during the current funding period?
• Has scientific synergy occurred, as indicated by joint publications and new collaborative aims and/or projects?
• Is there adequate justification for adding new projects and/or shared resources and/or deleting previous components?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the program. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Although applications from Foreign Organizations will not be accepted, application from Domestic institutions may have foreign components as part of the proposed projects or shared resource cores. If this is the case, reviewers will assess whether the foreign component special opportunities for furthering the research program 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 convened by the NCI in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center 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.

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

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

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

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

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

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

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

Not Applicable.

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

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

Referral Officer
Program Coordination and Referral Branch
Office of Referral, Review, and Program Coordination
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

Lan Nguyen
Grants Management Specialist
Office of Grants Administration
National Cancer Institute, NIH
8490 Progress Drive, Suite 4078
Frederick, MD 21701
Phone: (301) 631-3006 Fax: (301) 631-3030
Email: nguyenla@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 Parts 74 and 92.