It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Population-based Research to Optimize the Screening Process (PROSPR) is the National Cancer Institute (NCI) program to promote research aimed at evaluating and improving the cancer screening process. The reissued PROSPR program comprises two Funding Opportunity Announcements (FOAs) that solicit applications for:

• PROSPR U24 Coordinating Center (PCC) (this FOA); and
• PROSPR UM1 Research Centers (PRCs) (a companion FOA, RFA-CA-16-016).

The overall goal for the PROSPR Research Centers is to enhance understanding of the implementation and effects of screening as practiced in multiple healthcare environments in the United States.

The purpose of this Funding Opportunity Announcement (FOA) is to support a Coordinating Center that will provide scientific guidance and support in certain areas to three PROSPR Research Centers (one each focused on cervical, colorectal, and lung cancer, covered by RFA-CA-16-016). The Coordinating Center will serve as an intellectual hub for network research that is focused on more than one cancer type, with specific emphasis on development of two sets of common measures: health system-level characteristics that impact the cancer screening process and indicators of screening quality. It will also develop processes for proposing and conducting research that includes two or more PROSPR Research Centers (RFA-CA-16-016), and oversee data analysis and timely completion of these projects. Finally, it will develop and implement a process for PROSPR data access by qualified outside investigators.

Key Definitions for the context of this FOA:

• Healthcare system: a collection of primary and specialty care clinicians and support staff, medical facilities, and organizational structures which together provide the environment for the comprehensive delivery of healthcare services related to the cancer screening process, from determination of screening eligibility through treatment of benign precursor or malignant disease diagnosed through screening.
• Community settings: Environments in which the process of delivering healthcare reflects approaches typically followed by clinicians whose primary responsibilities are patient care rather than research or education. Patients in these environments tend to be more representative of the local population than are patients referred to academic medical centers for specialty care or who are enrolled in clinical trials.

Cancer Screening as a Complex Process. Cancer screening is not a single test, but a complex process that involves multiple steps: (1) determination of patient eligibility for screening and invitation for screening, (2) performance of the screening test and interpretation of results, (3) diagnostic follow-up of those with abnormal screening examinations, and (4) referral for treatment of benign precursor lesions and/or malignant cancers that are diagnosed. And, in fact, each of these steps can be broken down to identify sub-steps which healthcare staff and patients must complete. Successful completion of each of these steps is necessary for maximal screening benefits to be achieved. Conversely, breakdowns at any point in the process can lead to suboptimal outcomes. Furthermore, screening occurs within healthcare systems that encompass organizations, medical teams, administrators, and patients, all of which interact in complex ways to impact the utilization and quality of medical services provided. Screening process breakdowns thus depend on multilevel factors including, for example, patient non-compliance, failures on the part of medical providers or healthcare systems to provide appropriate follow-up testing and treatment, or failures of the screening or diagnostic tests themselves to detect disease.

Additionally, both the conduct of high-quality screening and the measurement of screening quality are difficult. In 2001, the Institute of Medicine proposed six domains of healthcare quality, stating that healthcare systems should aim to provide care that is: safe, effective, patient-centered, timely, efficient, and equitable. However, common conceptualizations and metrics for measurement of these quality domains across cancer types are lacking. Lack of these measures of quality impedes the iterative improvement of cancer screening across the US.

PROSPR I: Accomplishments and Research Gaps. Population-based Research Optimizing Screening through Personalized Regimens I (PROSPR I) was established in 2011 to measure the process of cancer screening for breast, colorectal, and cervical cancer in community settings. PROSPR I established an infrastructure to evaluate the screening process and to pool data across research centers to create standard metrics of population-based progress through the screening process (percent of eligible population screened, percent of individuals with abnormal results, percent of those with abnormal results who receive appropriate diagnostic testing, percent of individuals with cancer or benign precursor lesions who are appropriately treated). The PROSPR I investigators established the feasibility of documenting these process metrics, characterized heterogeneity in screening performance across systems, and documented disparities between populations treated in different healthcare systems. Despite the progress in PROSPR I, persistent questions remain about what factors drive the observed heterogeneity between healthcare systems in the screening process, how those variations affect the quality of care, health disparities in access to high-quality screening, and the long-term consequences of screening.

New Opportunities. Several developments since the funding of PROSPR I provide new opportunities for research to improve the cancer screening process. First, there have been several changes in the healthcare environment that have impacted cancer screening. A report by the National Academy of Medicine described cancer care in the US healthcare system as "in crisis", and congress passed legislation to increase access to care. Therefore, new concerns have arisen about how to measure quality, how the changing of incentive structures affects the screening process, and how variation in quality is affecting outcomes. Second, in 2011 the United States Preventive Services Task force for the first time recommended routine lung cancer screening in high-risk populations, generating questions regarding how to best implement screening. Third, increasing recognition of the interplay among characteristics of patient, provider, and healthcare delivery setting have focused attention on the need for measures of characteristics of the organizations. Finally, important questions remain regarding long-term effects of screening and factors that affect breakdowns in the screening process as they occur over multiple rounds of screening/surveillance. These questions require additional years of longitudinal data collection to allow for the accrual of larger numbers of cancer outcomes.

The reissuance of PROSPR is structured to make progress toward addressing these significant questions.

This initiative is being reissued under the modified name of Population-based Research to Optimize the Screening Process II (PROSPR II). The overall goal of PROSPR II is to increase our understanding of healthcare system, provider, and individual level factors that affect the quality of cancer screening in the United States, in order to improve the cancer screening process. An important focus of the reissuance is how these factors affect variation in populations with diverse racial/ethnic, socioeconomic, and healthcare access characteristics. To that end, a companion FOA (RFA-CA-16-016) is soliciting applications for PROSPR Research Centers (PRCs) focused on one of the following cancers: cervical, colorectal, or lung. The NCI intends to fund one PRC for each cancer type.

The Coordinating Center will provide scientific guidance and support to the 3 PRCs, and will have 3 major roles:

1. Leading the development of common conceptualizations and measures for 2 aspects of monitoring the screening process: assessing the role of systems-level factors that impact the screening process, and assessing screening quality;

2. Facilitating research that uses the above measures to compare the screening process across at least 2 of the cancer types listed above (i.e., via collaborations involving 2 or 3 PRCs, "trans-PROSPR" research), and;

3. Developing and implementing a process to support sharing of PROSPR data with qualified investigators who are not part of the PRCs, PCC, or NCI's PROSPR II scientific team.

The Coordinating Center will need to establish collaborative relationships with each of the PRCs, in order to understand the data capabilities and research program of each center. With this knowledge the Coordinating Center, in collaboration with the PRCs, will identify commonalities in the centers' approaches to evaluating system-level factors and screening quality, and facilitate the development of common conceptualizations and metrics to evaluate these factors. These metrics will then be applied across cancers in collaborative research studies that include at least 2 PRCs. Finally, the Coordinating Center will be responsible for establishing a process in which multi-cancer research studies are proposed and recommended by the PROSPR Steering Committee, and for data analysis in support of these studies.

The Coordinating Center will also develop and implement a process to share PROSPR II data with other investigators outside of the PROSPR network. The NCI is committed to having PROSPR serve as a research resource that can be accessed by the extramural community, to expand the depth and breadth of research that can be conducted. Consequently, there is an expectation that PROSPR investigators make data and scientific resources available to external investigators for research purposes. This research will generally be conducted in collaboration with PROSPR investigators, as successful research projects will depend on detailed knowledge of the strengths and limitations of the data, as well as the context in which screening-related healthcare is delivered in the participating PROSPR healthcare systems. The Coordinating Center will develop and oversee a process by which potential external collaborators can learn about the network and propose research projects to be vetted by the Steering Committee.

Tasks of the PROSPR II Coordinating Center are varied, and consequently it is expected that the study team be assembled with appropriate expertise in such areas as:

• Health services and healthcare delivery
• Implementation science
• Cancer epidemiology, including specifically expertise in screening for each of the 3 target cancer types
• Health disparities research
• Biostatistics
• Bioinformatics and health information technology

To increase the likelihood that the functions and tasks of the Coordinating Center can be performed successfully, applicants should have experience in coordinating multi-institutional, trans-disciplinary research. In addition to its scientific duties, the PCC will also be responsible for the administrative management of trans-PROSPR network activities. This includes but is not limited to facilitating the formation of working groups, scheduling and coordinating logistics of teleconferences and in-person meetings, and approval and tracking of trans-PROSPR research studies.

Program Evaluation

PROSPR II will be subject to evaluation by scientists based outside of NCI, the PRCs, and the Coordinating Center near the end of the third year of the funding period (details under Cooperative Agreement Terms and Conditions of Award).

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

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

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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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
• 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 not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit only one application in response to this FOA.

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

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

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

It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

V. Paul Doria-Rose, DVM, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6904
Fax: 240-276-7906
Email: [email protected]

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

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

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

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

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

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

Facilities and Resources: Include any information about available unique resources and/or special capabilities that may be relevant for future network collaborative research activities.

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

Please identify investigators who will lead the various tasks for the PCC, specifically administrative/management, measures development, trans-PROSPR research procedures, and data sharing procedures. Also indicate other specific individuals who may be considered Senior/Key Personnel.

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

PD/PI Effort Commitment. Any PD/PI (whether designated as contact or not) must commit a minimum of 1.2 person-months per year to the award. This commitment cannot be reduced in later years of the award. Note that this is a minimum effort level that should be increased as appropriate to meet the needs of the work.

In the budget justification, provide budget breakout for the individual tasks of the PCC (i.e., administrative functions, measures development, trans-PROSPR research, and data sharing procedures).

It is expected that the approximately 70% of direct costs requested would be allocated to measures development and trans-PROSPR research combined. Note that the effort devoted to measures development may predominate in earlier years of funding, and trans-PROSPR research may predominate later.

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

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

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

Specific Aims: Outline the general objectives of the proposed PROSPR Coordinating Center and the

overall approach to achieving these goals.

Research Strategy: The Research Strategy section should document the applicant's experience in coordinating multi-institutional, trans-disciplinary research, and should outline plans for carrying out the main functions of the Coordinating Center. The Research Strategy section must consist of subsections A-D as designated below.

Subsection A. Administrative processes for the PCC

• Explain the collective capabilities of the study team in terms of their qualifications and experiences in coordinating large, multisite research initiatives, and their qualifications in conducting cancer screening research in community settings. Emphasize how the combined, interdisciplinary experience of the team will meet the needs of the PCC activities. Do not repeat information already provided in biosketches.
• Describe the organizational and governing structure for the PCC, lines of authority, and decision making processes.

Subsection B. Measures Development

Propose a process for interacting with the PRCs and NCI to develop standardized frameworks and measures to assess (1) system-level factors that may be associated with the screening process, and (2) screening quality. Include a discussion of:

• The collective expertise and qualifications of the study team in assessing system-level factors and cancer screening quality (do not repeat information already provided in biosketches).
• Vision and rationale for key data to be collected in assessing system-level factors and screening quality.
• A proposed process and timeline for incorporating and harmonizing system-level factors and screening quality data captured by individual PRCs into a broader context that cuts across cancer types.

Subsection C. Trans-PROSPR Research

Propose a process for the development and conduct of trans-PROSPR research studies (i.e., those involving more than one cancer type and PRC) within the PROSPR II network. Include a discussion of:

• Vision for the types of research projects that could be conducted across 2 or 3 cancer types.
• Proposed approach to the development of data sharing processes.
• Proposed process and timeline for the solicitation, prioritization, selection, and conduct (including data analysis) of the research projects.

Subsection D. Data Sharing Process Development

Outline a process by which the PCC will work with the PRCs and with NCI to develop policies and procedures for qualified investigators outside of the PROSPR II network to gain access to data for research purposes.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

• 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 as described in the SF424 (R&R) Application Guide.

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow our Post Submission Application Materials policy.

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

For this particular announcement, note the following:

Merit evaluation should reflect the likelihood that the Coordinating Center can promote research across multiple PRCs with a high potential for improving the cancer screening process. The review should emphasize on the applicant's vision for assessment of the screening process (especially development of common conceptualizations and measures of system-level factors and screening quality), and the proposed processes for stimulating collaborative research.

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

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

Significance

Does the proposed Center address the needs of the research network that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?

Specific to this FOA: Is the PCC’s vision for the assessment of system-level factors and screening quality likely to lead to research that will improve the cancer screening process?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing cancer screening process research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA: Is the range of expertise of the investigator team sufficient to facilitate the conduct of high-impact research related to the cancer screening process? Is the collective expertise of the team sufficiently broad and interdisciplinary? What is the experience of the participating investigators in large-scale collaborative research in community healthcare settings?

Innovation

Does the application propose novel organizational concepts in coordinating the research network the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts proposed?

Specific to this FOA: Does the applicant propose novel approaches for the assessment of system-level factors and screening quality? Does the applicant's vision include collection of data elements that have not or have rarely been collected before but that have high potential for improving our understanding of how to improve the screening process? Does the applicant propose innovative methods for gaining insight into improving the cancer screening process?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? How appropriate are the proposed work-flow and timeline? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this FOA: Are the proposed processes and timelines for developing collaborative research between multiple PRCs and for data sharing with outside investigators likely to result in successful collaborations and impactful research? How promising are the approaches and timeline for harmonizing system-level factors and screening quality data captured by individual PRCs into a broader context that cuts across cancer types? Will the plan proposed for the analysis of data from multiple PRCs promote the successful completion of trans-PROSPR research?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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

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

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

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

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

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

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

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

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

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

As part of the scientific peer review, all applications:

• 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 score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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:

• Leading the development of common conceptualizations and measures for 2 aspects of the screening process: assessing the role of systems-level factors, and assessing quality;
• Implementing a process for the development, approval, and conduct of research that uses the above measures to evaluate the cancer screening process across multiple cancer types (i.e., via collaborations involving 2 or 3 PRCs), and participating in the development and conduct of this research as appropriate;
• Overseeing the conduct of data analysis in support of approved PROSPR research that involves multiple cancer types;
• Developing and implementing a process to support the sharing of PROSPR data with qualified investigators who are not part of the PRCs, PCC, or NCI;
• Serving as voting members on the PROSPR Steering Committee;
• Attending a "kickoff" meeting at the beginning of the funding period;
• Participating in in-person scientific meetings twice a year, and twice-monthly teleconferences;
• Abiding by the PROSPR governance document, which will be developed during the first year of funding, and by decisions of the PROSPR Steering Committee;
• Providing information to the NCI Program Director and NCI Project Scientists concerning progress by submitting annual progress reports in a standard format, and by providing additional information as needed;
• Hosting annual site visits to be conducted by NCI staff;
• Cooperating with NCI Project Scientists in the program evaluation process;
• Committing a minimum of 1.2-person-months effort per year to the award; and
• Assuring that appropriate administrative and logistical support is provided to coordinate trans-PROSPR research activities (including but not limited to facilitating the formation of working groups, scheduling and coordinating logistics of teleconferences and in-person meetings, and approval and tracking of trans-PROSPR research projects).

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 DHHS, PHS, and NIH policies.

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

One or more NCI Project Scientists will have the following responsibilities:

• Advising on the development of common conceptualizations and metrics for assessing the role of systems-level factors that impact the screening process, and assessing the quality of the screening process;
• Participating in the development and conduct of trans-PROSPR research as appropriate;
• Collaborating with the PROSPR investigators in some shared activities, including co-authoring papers if appropriate;
• Serving as voting members on the PROSPR Steering Committee
• Attending a "kickoff" meeting at the beginning of the funding period;
• Participating in in-person scientific meetings twice a year, and twice-monthly teleconferences;
• Monitoring the operations of the PRCs and the PCC, and making recommendations on overall project directions and allocations of project funds;
• Reviewing the individual progress of the PRCs and PCC, as well as the progress of multisite PROSPR collaborations;
• Assisting the PROSPR awardees as a liaison in stimulating their broader interactions with other NCI and NIH programs to disseminate results and outcomes from the PROSPR program and effectively leverage existing NIH/NCI resources and infrastructures;
• Evaluating the adherence of PROSPR awardees to the approved data sharing plans and intellectual property plans; and
• Conducting site visits for all PRCs and the PCC annually.

Additionally, an NCI Program staff member will serve as Program Official, who will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award.

Areas of Joint Responsibility include:

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

• Three representatives from each PRC (or more if necessary, such that there is one representative from each participating healthcare system), who will collectively have one vote;
• The PD(s)/PI(s) of the PCC who will collectively have one vote; and
• The NCI Project Scientists who will collectively have one vote.

The PROSPR Steering Committee will meet at least twice annually in person. A chair of the Steering Committee will be selected at the first meeting to coordinate the committee's operation, and will serve a term of 12 months.

The PROSPR Steering Committee will have the following primary responsibilities:

• Reviewing and prioritizing the trans-network research goals, and overseeing the overall progress of trans-PROSPR research activities;
• Establishing advisory committees and subcommittees, as necessary, to ensure the progress of PROSPR's collaborative research;
• Approving and prioritizing collaborative research projects that include multiple PRCs and/or investigators external to the PROSPR network;
• Participating in the development of an agenda for the biannual PROSPR scientific meetings; and
• Developing a PROSPR governance document for trans-PROSPR work, which must be drafted and approved during the first year of funding.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

V. Paul Doria-Rose, D.V.M., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6904
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email:[email protected]

Becky Brightful
National Cancer Institute (NCI)
Telephone: 301-631-3011
Email: [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 Part 75.