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 UM1 Research Centers (PRCs) (this FOA); and
• PROSPR U24 Coordinating Center (PCC) (a companion FOA, RFA-CA-16-017.)

The overall goal for PROSPR Research Centers is to enhance understanding of the implementation and effects of screening as practiced in multiple, heterogeneous healthcare environments in the United States. The research programs proposed must cover long-term observations of diverse cohorts of patients who are eligible for screening. In addition to observational research to evaluate factors that affect the quality of the screening process, these programs must also develop and pilot-test interventions aimed at improving the screening process.

It is expected that this FOA will support one PROSPR Research Center for each of the three targeted cancer types: cervical, colorectal, and lung cancer. Each proposed Research Center must be entirely focused on screening for one of these three eligible cancer types.

In addition, proposed PROSPR Research Centers must be able to study the cancer screening process in at least three different healthcare systems. Therefore, appropriate collaborative arrangements with providers of screening/diagnostic services in each system are required.

Research Centers will be expected to closely interact with the PROSPR Coordinating Center, whose primary focus will be the development of common conceptualizations and measures of health system-level factors that impact the screening processes, as well as common conceptualizations and measures of screening process quality. The Coordinating Center will also play a main role in developing research activities that utilize these measures for the study of the screening process across more than one cancer type (i.e., collaborations between more than one PRC). These collaborative studies will be identified after funding, through interactions between the PRCs, the PCC, and the NCI.

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 as a result of 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. Patient populations 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, we are 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.

General Requirements

Each proposed PRC must focus on one cancer type. Applications focusing on cancer types other than cervical, colorectal, and lung will be considered non-responsive and will not be reviewed. Each PRC will document the entire screening process in community practice, and conduct research relevant to improving that process. The proposed research programs must be based on access to comprehensive cancer screening data for defined populations in the U.S. Funding priority will be given to those applications that are assessed by peer review to have particularly high potential for improving the screening process. Based on the nature of PROSPR research, applicants should enlist participation and have strong support from the clinical and the organizational leaders of the included healthcare systems. This is necessary to assure access to electronic medical records and other data required for the acquisition of high-quality screening process data. Further descriptions of key features of the PRCs are provided under the subheadings below.

Health Systems. In order to meet the goal of studying the cancer screening process in diverse populations, each PRC must include at least three distinct healthcare systems as data-contributing sites. Each system should be able to capture data for a minimum of 50,000 patients eligible for screening. Combinations of systems should be selected to maximize heterogeneity, such that multiple environments in which care is provided in the US (e.g., managed care, safety-net settings, primary care networks) are represented. Due to the data requirements for PROSPR II, each participating health system must have the ability to capture comprehensive individual-level information about each step of the cancer screening process (population eligible for screening including those who do not elect to be screened, performance of and results of screening tests, diagnostic follow-up exams performed and results, diagnosis and treatment of benign precursor lesions and cancer). Eligible systems are those which can comprehensively capture data for all steps in the screening process (for at least an identifiable subset of the overall patient population receiving care within the system). Finally, it is expected that PROSPR II research staff have close working ties with the health system providers and operations staff, in order to maximize both the ability to document health-system level characteristics and the potential for translational research.

Data to Be Collected. It is essential that each healthcare system within the PRC be able to collect high-quality data documenting each step of the screening process from assessment of eligibility for screening through diagnostic follow-up and treatment; this is required so that PROSPR can continue to calculate the screening process metrics developed during PROSPR I. In addition, data must be collected on factors that could impact the screening process at every level (i.e., patient, provider, healthcare system), and measures of quality which may include the domains defined by the Institute of Medicine and quality measures associated with the screening examinations themselves (e.g., adenoma detection rates, quality of bowel preparation). These requirements extend beyond data that were collected in PROSPR I. In addition to prospective data, the ability to include retrospective data that dates back to the year 2010 is strongly encouraged for the colorectal and cervical PRCs. It is recognized that retrospective data may be less available for the lung PRC, due to the recent introduction of lung cancer screening into clinical practice; however, inclusion of retrospective data dating back to the time of introduction of lung screening into the participating health systems is desired. Since some screening tests (e.g., colonoscopy) have longer screening intervals, the inclusion of retrospective data will allow researchers to address a broader range of research questions, including those dependent on patients returning for subsequent screening or surveillance. It also is recognized that the proportion of the population eligible for lung cancer screening may need to be estimated if detailed smoking history data are not available, although it is highly desirable that individual-level data on years smoked, amount smoked, and date quit be available for those not screened.

For prospectively collected data, the development of novel data systems that capture screening process data in a standard way for all included health systems is strongly encouraged. This standardization will maximize the comparability of data across the different PRC health systems. For example, the use of a standard form to capture indication for exam (i.e., whether done for screening, surveillance, or due to symptoms) or risk factor information, or the incorporation of standard forms or the use of report templates that will allow for the extraction of standard blocks of easily extractable text (from pathology or radiology reports, for example), is highly desired. This preference for data standardization underscores the need for a close relationship between researchers and clinical/operations leaders, as new data collection techniques would need to be designed to have as little impact on clinical workflows as possible and to serve the needs of both research and clinical care. If development of new data collection systems is not possible, then other post hoc techniques to define key variables (e.g., natural language processing) are permissible, if validated via a rigorous process.

Data related to screening results and pathologic diagnoses must be sufficiently granular to connect the results/diagnosis to expected clinical follow-up according to guidelines. For example, the use of standard results reporting systems (e.g., Lung-RADS), and capture of sufficient detail about colorectal polyp number, size, and histology or Pap/HPV result and cervical biopsy diagnosis to assign individuals to an expected follow-up category, is required. Capture of additional details, such as number and characteristics of lung nodules identified, is encouraged.

Data will also need to be collected to measure health system level factors that may affect the screening process (e.g., incentive structures and potential changes in those structures during the course of the research, clinical leadership characteristics and changes). These data may be both retrospective and/or prospective, extracted from existing data and/or newly collected, and may be qualitative or quantitative. PRC awardees will be expected to collaborate on these aspects with the PCC, which will lead the network activities in conceptualizing and measuring these factors as consistently as possible across all PRCs.

Beyond data required for the documentation of the entire screening process, additional data collection should focus on the needs of specific projects to be conducted as part of the Research Program (see below). It is expected that data needs will evolve over the course of the funding period, and that additional data development will occur at each PRC for use in trans-PROSPR research studies, and for new high-priority studies focused on a single cancer type that are identified based on new PROSPR II and non-PROSPR research findings published during the PROSPR II funding period.

Diverse Populations. At present, the benefits and harms of screening are not equally distributed across the US. As such, a key feature of PROSPR II is to evaluate health disparities, and develop solutions to facilitate more equitable access to high-quality cancer screening. To promote research focused on ameliorating health disparities, each PRC must include populations that belong to diverse racial or ethnic minority groups; are of lower socioeconomic status; identify as gay, lesbian, bisexual or transgender; and/or have difficulty accessing care because of factors such as rural location or residence in other areas designated by the Health Resources and Services Administration as medically underserved.

Data Sharing. 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 PCC will have responsibility for developing and overseeing a process by which potential external collaborators can learn about the network and propose research projects to be vetted by the Steering Committee. It is expected that all PRCs will participate in the development of this process, and collaborate with external researchers as appropriate in projects approved by the PROSPR Steering Committee.

Research Center Organization

Each PROSPR II PRC should be composed of the following functional and structural units:

• Administrative Core
• Data Acquisition Unit
• PRC Research Program
• Trans-PROSPR Research Core

Administrative Core. This core will be responsible for the day-to-day management of all PRC activities, and should provide infrastructure that will allow the PRC leadership to oversee all other units and ensure that they are operating in a well-coordinated fashion. Because PROSPR II requires that complex data be collected from at least 3 different healthcare systems and be incorporated into multiple research projects, efficient lines of communication are needed between this core and the 3 participating health systems.

Data Acquisition Unit. This unit will be responsible for the collection and management of the multilevel screening process data and intervention pilot data.

PRC Research Program. This program will conduct research focused on the single cancer type that is the focus of the PRC. Initial research, which will be observational in nature, will evaluate modifiable factors, on multiple levels, associated with the successful completion of and quality of the screening process. A key focus of this observational work should be the identification of potential targets on which to intervene; results of the observational work will lead to the design of at least one intervention that can be pilot-tested at each of the component healthcare systems of the PRC.

Scope of the PRC Research Program

Areas of focus of the research program are likely to be different for different cancer types, and should be based on the most critical needs due to current gaps in evidence. Research projects should aim to identify factors that may be modified to improve the screening process, as the ultimate goal is to improve outcomes by identifying points in the process at which to intervene. During approximately the last 2 years of the funding period, it is expected that at least one intervention, developed based on observational research in the earlier years of the award, will be pilot-tested in all health systems of the PRC. The intervention(s) will attempt to improve screening rates and/or promote appropriate diagnostic follow-up and treatment, and should be selected on the basis of the observational research findings. Interventions that would be portable to other healthcare organizations are preferred, in order to maximize the reach and impact of the PROSPR II research program.

A minimum of 3 observational research studies must be proposed by each applicant. These may be interconnected, or not, as deemed appropriate to address the issues facing the screening process for the given cancer. Of key importance is that the research program uncover and characterize shortcomings in the cancer screening process, in order to fill existing research gaps and lead to ways to improve the cancer screening process. Research studies should be focused on multiple levels (e.g., patient, provider, health system, policy/insurance), and a sufficient breadth of research should be proposed to maximize the likelihood that at least 1 promising target area for the development of an intervention will be identified.

Types of observational research studies that may be proposed by a PRC include:

• Comparative effectiveness: compare the benefits and harms of alternative screening regimens (e.g., utilization of different screening modalities, at varying intervals, or tailoring screening strategies to individuals' underlying risk of developing the cancer of interest; performance of alternative follow-up regimens among those with abnormalities diagnosed at screening).
• Characterizing screening process failures: study determinants of breakdowns at any step of the process including: (1) failure to recruit eligible patients into the screening process; (2) failure to perform appropriate diagnostic follow-up of those with abnormal screening results; or (3) failures of screening or diagnostic tests to detect disease, due to inherent performance characteristics, subjective interpretation by and differential skills of those performing the tests and/or reading the test results, or the environment in which the test is conducted. Study of factors associated with over-screening or over-surveillance (e.g., in ineligibles or overly frequently), or factors associated with false-positive rates for screening or diagnostic tests, are also encouraged.
• Characterization of the health care environment: how do characteristics of the component healthcare systems of the PRC (e.g., organized screening programs, reminder systems, communication between provider teams, incentive structures) positively or negatively impact the cancer screening process?
• Differential experience of racial/ethnic minority or socioeconomically or otherwise disadvantaged populations: how does the screening process differ in medically underserved populations, and what is needed to improve screening-related care in these populations?
• Simulation modeling to determine which potential intervention points within the screening process have the most potential to improve patient outcomes.

Trans-PROSPR Research Core. Finally, this unit will serve as the interface with the other PRCs and the PCC, in order to develop two sets of common measures: system-level factors that may impact the screening process and common measures of screening quality. It will also participate in research studies that use these measures to evaluate the screening process across multiple cancer types.

Scope of Trans-PROSPR Research

The majority of PROSPR II research is intended to be conducted within PRC (i.e., to be focused on one type of cancer). However, in PROSPR I there was also a large benefit to promoting dialogue and research collaborations across cancer types. To that end, we also require that PRCs participate in a small number of trans-PROSPR research studies, which are defined as collaborations between at least 2 PRCs. This research will be prioritized and directed in partnership with the PROSPR II Coordinating Center (RFA-CA-16-017) and NCI. To inform the development of trans-PROSPR projects, the Coordinating Center will take the lead in developing common conceptualizations and measures of health system-level factors and screening quality factors that may influence the screening process differentially according to cancer type.

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 Terms and Conditions).

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

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 more than one application, provided that each application is scientifically distinct i.e., focused on different cancer types. Furthermore, healthcare systems may not serve as data-contributing sites in more than one application focused on the same cancer type.

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 additional specific requirements.

The Research Strategy must consist of the following sub-sections with the indicated page limits:

Sub-section A. Overview of the Proposed PROSPR Research Center--12 pages

Sub-section B. Administrative Core--6 pages

Sub-section C. Data Acquisition Unit--12 pages

Sub-section D. PRC Research Program--12 pages

Sub-section E. Trans-PROSPR Research Core -- 6 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. Additional guidance applies.

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

Other Attachments: Applicants must upload the following information (in tabular form, if possible).

• Healthcare system characteristics, including environment in which care is provided (e.g., managed care, safety-net settings, primary care networks), information about facilities, and number and characteristics of providers
• Patient characteristics in each participating healthcare system, including number of patients eligible for screening, demographics with special attention to representation of racial/ethnic minority groups and other underserved populations, proportion screened and results of screening examinations, incidence rates of benign precursor and invasive disease for the cancer type of interest, and other relevant information as appropriate; and
• Data sources and data collection strategies.

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

Please identify investigators who will lead individual cores/units/research studies, and 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 Center structural/functional units (i.e., Administrative Core, Data Acquisition Unit, and PRC Research Program, and Trans-PROSPR Research Core).

It is expected that approximately 70% of the direct costs requested will be allocated to the Research Program and Data Acquisition Unit, combined.

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 Research Center and the overall approach to achieving these goals.

Research Strategy: The Research Strategy section must consist of subsections A-E as designated below.

Sub-section A. Overview of the Proposed PROSPR Research Center

Present the overall vision for the proposed PROSPR Research Center, including the following aspects:

• Overview of key issues related to the evaluation of the screening process for the cancer of interest;
• A broad background of the participating health systems included in the PRC, with particular emphasis on describing heterogeneity in the systems included (e.g., healthcare environment, inclusion of racial/ethnic minority and medically underserved populations*);
• Without repeating information in biosketches, explain how the expertise of the study team will be integrated for the goals of the Center (with particular attention to the conduct of multilevel, multidisciplinary cancer screening research); and
• Description of the involvement of clinical and operations leaders of the participating healthcare systems.

*Note: Supplementary information pertaining to this sub-section has to be provided (see "Other Attachments", above).

Sub-section B. Administrative Core

Outline how the Administrative Core will manage the operations of the PRC, including:

• Describe the organizational and governing structure for the PRC, lines of authority, and decision making processes.
• Outline plans for coordinating interactions among the functional units of the PRC

Sub-section C. Data Acquisition Unit

Provide a comprehensive description of data sources and strategies for collecting and linking multilevel screening process data from multiple sources within your defined population (can also be summarized in "Other Attachments", above). Address the following elements:

• The health systems' abilities to actively participate in and support the collection of comprehensive, multilevel cancer screening process data by your PROSPR research center. Describe how the health systems' clinical and operations leaders and research center staff will interact to ensure efficient, timely, and complete capture of the relevant clinical data for research purposes.
• Document your center's capacity to retrospectively and prospectively collect and submit the following data elements (all elements are required unless otherwise noted). If different strategies will be used for collection of prospective versus retrospective data, please describe approaches for both.
• Patient level: age; race; ethnicity; types and extent of health insurance coverage and out-of pocket expenditures (e.g., deductibles, copays, self-pay) for cancer screening, follow-up, and diagnostic testing services; comorbidity burden; socioeconomic status (optional); educational attainment (optional); HPV vaccination status (required for cervical PRC); hysterectomy status (required for cervical PRC); smoking status including pack-years and time since quitting for former smokers (required for lung PRC, smoking status desired for all PRCs); timing and type(s) of testing for cancer; indication for test(s) (i.e. for screening, diagnostic, or surveillance purposes); measures of quality of screening tests (e.g., quality of bowel preparation); follow-up test(s) performed following a positive screening examination and their results; treatment(s) performed; measures of screening or diagnostic follow-up harms (e.g., gastrointestinal bleeding, pneumothorax, death post-procedure); diagnosis of benign precursor lesions (e.g., CIN, colorectal adenomas, with sufficient details to document expected clinical follow-up based on guidelines); cancer diagnosis, characteristics (TNM, grade, histology), and mortality (as determined via linkage to an AACR Gold Quality State or SEER Cancer Registry);
• Provider level: medical specialty of the referring and performing provider; provider type of the referring and performing provider (e.g. physician, nurse practitioner, physician assistant); years in practice;
• Practice/Facility level: practice type (e.g. primary care network, federally qualified health center (FQHC), HMO, etc.); practice size (i.e., number of FTE clinicians; types of clinicians in the practice); facility location; facility type (e.g. OB/gynecologist office, primary care clinic); number and types of providers performing cancer screening; type and features of EMR system used to support screening activities; screening guidelines in place for the cancer type of interest;
• Health system level: size and level of integration of healthcare system, presence and type of organizational factors to support the screening process (e.g., use of HEDIS measures); performance measurement and reporting to clinicians; use of incentives; presence of processes to support informed decision making; clinical leadership structure; clinical team structure.
• Describe your plans to process and store data.

Sub-section D. PRC Research Program

Divide the description of the PRC Research Program into two main blocks:

• Observational research (to be the main focus for the initial years of the award); and
• Intervention(s) to improve cancer screening process (to be conducted at the later stages).

More details are expected to be provided for the observational research, as these studies should be more precisely defined and more specific in terms of what will be accomplished during the funding period. Correspondingly, fewer details are acceptable regarding interventions, as more precise characteristics of the intervention(s) to be explored should emerge later and be informed by the results of the observational studies.

Observational research

Observational research is expected to identify, at multiple levels, factors that impact the completion and quality of the screening process. Please outline analyses that you plan to conduct, including preliminary data, hypotheses, research methods and statistical power. Analyses should be selected that represent the most relevant research questions that address evidence gaps for the cancer type of interest; research that is focused on ameliorating health disparities is of particular interest. Some studies may require additional data collection beyond the core data elements described in Sub-section C, above (e.g., physician surveys, analysis of clinical workflows, qualitative research involving samples of patients or providers). This additional data collection is encouraged as needed to address the most relevant scientific questions. A minimum of 3 studies (and more if needed or desired) must be proposed, which examine patient, provider and system factors that impact the screening process. These studies should be chosen to maximize the likelihood that at least one strong candidate for the development of an intervention will be identified.

Intervention(s) that aim to improve the cancer screening process

Intervention(s) that aim to improve the cancer screening process will be designed and pilot-tested during approximately the final two years of the award. Because the intervention(s) will be based on findings from the observational studies, specific interventions should not be proposed as part of this application. Rather, this section should include:

• Collective experience of the study team in conducting intervention research (do not repeat information already provided in biosketches).
• Scientific vision regarding key points in the screening process that represent potentially high-impact targets for intervention. (Note that this vision should also inform the selection of observational research projects described above.)
• A description of the proposed process to prioritize potential intervention(s) for development and pilot-testing.
• Commitment of the health systems to participation in the pilot-testing of the intervention(s) developed.

Note: The page limit stated earlier applies to the entire Sub-section D, regardless of the number of studies proposed (i.e., page limit is NOT on per-study basis).

Sub-section E. Trans-PROSPR Research Core

Finally, each PRC will work with the other PRCs and with the Coordinating Center to develop common conceptual frameworks and measures of healthcare system factors impacting the screening process as well as common frameworks and measures of screening quality. It is intended that this work will result in collaborative projects that are focused on more than one cancer type. The Coordinating Center will take the lead on this work, with input and collaboration from the PRCs and the NCI. This section should include:

• Summary of capabilities of the Center and the team (e.g., access to uncommon data types, unique tools and/or skills) that may be particularly useful for collaboration with other PROSPR investigators.
• Vision of how your PRC's core data elements and projects may be logically extended to the other 2 cancer types.

Letters of Support: Letters of support from clinical and operations leaders from each healthcare system should also be provided. The letters from healthcare systems should document their commitment to provide specific types and scope of data and, as applicable, the commitment to participate in the pilot-testing of the intervention(s) to be developed. These letters should also document willingness of clinical and operational leaders to make reasonable clinical workflow changes that will be needed to conduct pilot tests of interventions to improve the cancer screening process.

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:

Reviewers will emphasize whether applications clearly demonstrate the ability to collect high-quality screening process data and to conduct research with a high potential for improving the cancer screening process. Reviewers will also pay special attention to the breadth of research proposed in terms of adequately covering heterogeneous healthcare environments and diverse patient populations.

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

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

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

Specific to this FOA: Does the proposed Research Center have a high potential to improve the cancer screening process, and to decrease health disparities? Are the multilevel factors hypothesized to be associated with the completion and quality of the cancer screening process likely to explain variability in the process, and do they represent promising targets for intervention? Will results of the PRC's research program likely generalize to other healthcare organizations beyond the participating health systems?

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

Specific to this FOA: Is the range of expertise of the investigator team sufficient to facilitate the collection of high-quality data and the conduct of high-impact research related to the cancer screening process? Are representatives of key disciplines appropriately represented in the team? What is the experience of the participating investigators in large-scale collaborative research in community healthcare settings?

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

Specific to this FOA: Are novel approaches used that take advantage of electronic medical records systems and other data sources in the healthcare systems, in order to promote the efficient collection of high-quality, standardized screening process data? Are novel measures proposed to assess system-level factors and screening quality, for use in the evaluation of the cancer screening process?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA: Will the PRC be able to comprehensively document the cancer screening process for all participating health care systems, by capturing both prospective and retrospective data? What is the likelihood that the approach used for data collection/capture will yield high-quality, standardized, multilevel screening process data across all participating health systems?

Administrative Core: How efficient will be this unit in supporting administrative and coordinating functions of PRC?

Data Acquisition Unit: How strong is the ability to retrospectively and prospectively collect various types of data that are required and needed for the proposed research?

PRC Research Program: How meaningful and useful are the observational research studies proposed in the context of screening for the targeted cancer type? What is the likelihood that these observational studies will form a strong basis for the final design of at least one meaningful intervention? Are the directions anticipated for intervention research well thought out, connected to the observational research, and realistic?

Trans-PROSPR Research Core: How strong are the capabilities of the proposed Center and the team in terms of collaboration with other PROSPR investigators and extending research approaches to the other 2 cancer types?

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

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

Specific to this FOA: Does the proposed PRC include relevant racial/ethnic minority and/or other medically underserved populations, such that the PRC's research program can be used to address and improve health disparities pertinent to the cancer type of interest? Do the participating healthcare systems represent a variety of environments in which care is delivered in the US (e.g., managed care, safety-net settings, primary care networks), while still allowing for comprehensive capture of data from all stages of the cancer screening process? Is there a clear relationship between the PRC investigators and the participating healthcare systems that will facilitate the collaboration? Have the participating healthcare systems documented their commitment to participating in the PRC's research program to evaluate and improve the cancer screening process? Do the PRC investigators and collaborating healthcare systems have an established record of collaboration with one another?

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 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 appropriate national Advisory Council or 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. These priorities will include:
• The need to cover screening for all three eligible cancer types (i.e., the intention to support one Research Center for each cancer type);
• The diversity of the patient populations and healthcare environments included in the proposed research center, and the likelihood that the PRC's research program will ameliorate health disparities;
• The ability of the proposed research center to evaluate the screening process at multiple levels; and
• The capacity of the PRC investigators to collaborate effectively and productively.

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:

• Determining and coordinating research conducted as part of the PRC's research program;
• Collecting multilevel screening process data for all participating healthcare systems;
• Participating in the development and conduct of collaborative research with other PRCs, the PCC, the NCI, and investigators external to the PROSPR network including providing data for these analyses to the PCC on an as-needed basis;
• Sharing data with PROSPR and non-PROSPR investigators as part of research approved by the PROSPR Steering Committee
• Participating in 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;
• 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;

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 agency program official or IC program director 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.