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

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

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

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative intended to accelerate cancer research. The purpose of this FOA is to promote research in colorectal cancer (CRC) screening, follow-up, and referral-to-care in regions of the United States (U.S.) where screening rates are below national standards. Specifically, this FOA targets the following area designated as a scientific priority by the Blue Ribbon Panel (BRP): Prevention and Screening: Implementation of Evidence-based Approaches.

The Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) Program will provide an evidence base for multilevel interventions that increase rates of CRC screening, follow-up, and referral-to-care, and best practices for how multilevel interventions can be scaled-up to reduce the burden of CRC on the United States (U.S.) population.

The ACCSIS Network is comprised of the following:

ACCSIS Research Projects (supported under this FOA as well as its predecessor for the first wave of awards, RFA-CA-17-038)

ACCSIS Coordinating Center (funded in FY 2018 through RFA-CA-17-039)

Applicants responding to this FOA must propose both the UG3 and UH3 phases together in a single application. The UG3 Planning-Exploratory Phase (Year 1) is for pilot testing and refining a multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care. At the end of Year 1, achievement of scientific milestones and feasibility requirements will be necessary for transition to the UH3 Implementation Phase (Years 2-5). UH3s will be awarded after administrative review of these UG3 milestones pending availability of funds. During the UH3 phase, the revised multilevel intervention will be tested using an experimental or quasi-experimental study design. Awardees from this FOA will work with the NCI, other ACCSIS 1 and ACCSIS 2 Research Project awardees, and the ACCSIS Coordinating Center.

The overall goal of the ACCSIS Program is to provide national leadership on advancing the science on how best to increase adoption, implementation, and sustainability of evidence-based CRC screening, follow-up, and referral-to-care, particularly in regions of the U.S. where screening rates are below national standards. The ACCSIS Program will provide an evidence base for multilevel interventions that increase rates of CRC screening, follow-up, and referral-to-care, and best practices for how multilevel interventions can be scaled-up nationwide to reduce the burden of CRC cancer on the U.S. population.

Key Definitions for this FOA:

• ACCSIS Program: Refers to the combined effort of the ACCSIS 1 and ACCSIS 2 Research Projects, ACCSIS Coordinating Center, and the NCI, to advance the science of implementation of multilevel interventions to increase rates of CRC screening, follow-up, and referral-to-care.
• ACCSIS Program Committee: Includes representatives from the ACCSIS Coordinating Center, each ACCSIS Research Project, and the NCI.
• ACCSIS Coordinating Center: Includes the coordinating center funded through RFA-CA-17-039.
• ACCSIS Research Projects: Includes UG3 Planning-Exploratory Phase and the UH3 Implementation Phase research projects funded through this reissued RFA (RFA-CA-19-018; ACCSIS 2) and previously through RFA-CA-17-038 (ACCSIS 1).
• UG3 Planning-Exploratory Phase: One-year Planning-Exploratory Phase during which research teams are expected to pilot test, measure, and refine the multilevel intervention in preparation for using an experimental or quasi-experimental study design in the UH3 Implementation Phase.
• UH3 Implementation Phase: Four-year Implementation Phase during which research teams are expected to use an experimental or quasi-experimental study design to test the impact of a multilevel intervention on increasing rates of CRC screening, follow-up, and referral-to-care among target populations for whom screening rates are below national standards.
• Multilevel Intervention: An intervention that: 1) includes components that target change at two or more levels of individuals, healthcare or public health providers, or healthcare/community settings, and 2) measures outcomes at two or more levels. For this FOA, change refers to behaviors associated with adoption, uptake, and sustained use of evidence-based CRC screening, guideline-concordant follow-up, and appropriate referral to care. Selection of multilevel intervention components across different levels should be guided by relevant theories, models, or frameworks; a review of the extant literature; and local assessment of barriers and facilitators; and should include a priori hypotheses of how components are expected to affect each other as well as inform the selection and measurement of proposed outcome(s).

Levels include:

• Individuals: Individuals who receive or are the target of receiving CRC screening, follow-up, and referral-to-care services as well as those who are directly involved in supporting such individuals in their receipt of CRC screening, follow-up, and referral-to-care services. Examples include but are not limited to patients, caregivers, and family members.
• Healthcare or public health providers: Healthcare or public health providers. Examples include but are not limited to physicians, nurse practitioners, community health workers, and patient navigators involved in delivering healthcare practices, programs, interventions, and other health-focused services to individuals.
• Healthcare and/or community settings: Organization(s) in which individuals receive health-focused services across the cancer care continuum. Examples include but are not limited to clinics (e.g., primary care, specialty care), hospitals, cancer centers, federally qualified health centers, integrated delivery systems, health departments, and community-based organizations. Community organizations where people could be educated about CRC screening and/or opportunities for funding screening, follow-up, and referral-to-care can also be included.
• Experimental Study Design: Study design that includes manipulation (i.e., exposure to at least one intervention), randomization, and a control group. Experimental design studies must include prospective randomization of study subjects to one or more experimental condition(s) (i.e., multilevel intervention) and include a control condition (e.g., standard-of-care, comparison condition, time-attention control). Examples of experimental study designs include randomized controlled trials, cluster randomized controlled trials, pragmatic randomized controlled trials, and stepped-wedge cluster randomized controlled trials.
• Quasi-Experimental Study Design: Study design that includes manipulation (i.e., exposure to at least one intervention), no randomization, and a control group. Studies must include prospective exposure to an experimental condition (i.e., multilevel intervention) and include a control condition (e.g., standard-of-care, comparison condition, time-attention control). Examples of quasi-experimental study designs include interrupted time series, regression discontinuity, and nonequivalent control group.
• The terms Clinical Research and Clinical Trials in this FOA follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch.)

NCI convened the Blue Ribbon Panel (BRP) in 2016 to provide recommendations for achieving the Cancer Moonshot's ambitious goal of making a decade's worth of progress in cancer research in 5 years, now called the Beau Biden Cancer MoonshotSM Initiative. The BRP was charged with assessing the state-of-the-science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and in how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation for a strategic investment in the development and testing of implementation strategies to significantly improve CRC screening, follow-up, and referral-to-care, particularly among underserved populations. The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer MoonshotSM Initiative, including support for this FOA.

Challenges Associated with CRC Screening. CRC is the second leading cause of cancer deaths in the U.S., and screening is a major factor with a documented potential for decreasing CRC mortality rates. However, the current U.S. screening rate is below 50%, and almost 30% of eligible adults have never been screened for CRC. These rates are well below the national goals set by the National Colorectal Cancer Roundtable (NCCRT; 80% by 2018) and by Healthy People 2020 (70.5%). In addition to CRC screening, rates for appropriate CRC follow-up and referral-to-care (e.g., additional tests, diagnosis, treatment, active surveillance, watchful waiting, survivorship, where indicated) are suboptimal. Among traditionally underserved and marginalized populations, such as those residing in rural areas, racial and ethnic minority populations, and low-income populations, rates for CRC screening, follow-up, and referral-to-care are particularly low relative to other target populations, although rates collectively remain well below the national target.

Current Approaches to Increase CRC Screening. Currently, there exist many evidence-based tests, practices, programs, interventions, and approaches demonstrated to reduce CRC-related mortality, including those related to CRC screening, follow-up, and referral-to-care. Recommended CRC screening tests include fecal occult blood testing (FOBT), guaiac-fecal occult blood test (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy, and colonoscopy. To promote uptake of these screening tests, more than fifteen evidence-based interventions are available (see NCI’s Research-Tested Interventions Programs [RTIPs] for details). These interventions have been developed to increase CRC screening rates for many target populations (e.g., American Indians/Alaska Natives, Asians/Pacific Islanders, Blacks/African Americans, Hispanics/Latinos, Native Hawaiians, low-income populations, and rural populations) using various delivery modes (e.g., telephone calls, mailed brochures, educational sessions, patient navigation), and across delivery settings (e.g., community-based organizations, faith-based organizations, clinical care). Researchers have also identified ways to increase the adoption and appropriate use of evidence-based interventions among patients, providers, teams, organizations, communities, and systems of care. Dozens of implementation strategies have been identified in the literature; examples include supervision, technical assistance, coaching, payment/financing, training, champions, leadership training, organizational change interventions, learning collaboratives, audit and feedback, and partnerships.

Multilevel Interventions to Increase CRC Screening. Efforts to increase rates of CRC screening, follow-up, and referral-to-care have mostly focused on developing and testing single-level interventions (i.e., those targeting change at one level, such as patients, providers, or clinics/organizations). However, single-level interventions are often insufficient to lead to sustained change in CRC screening, follow-up, and referral-to-care rates. To have a significant impact on reducing CRC-related mortality, multilevel interventions are needed to increase the adoption and appropriate use of evidence-based CRC screening, follow-up, and referral-to-care interventions. Multilevel interventions are those that address two or more levels of change, which may include patient-level barriers (e.g., access to care, cost, lack of awareness, fear of results), provider-level barriers (e.g., unfamiliarity with clinical guidelines, limited shared decision-making skills, competing demands), and/or clinic/system/organizational-level barriers (e.g., poor organizational culture and climate, lack of systematic or electronic reminder systems). Essential to this multilevel approach is the explicit description of a priori hypotheses. These hypotheses address how proposed multilevel intervention components are expected to affect each other, as well as how multilevel intervention components will affect the desired outcome(s). Hypotheses, mechanisms of change, and intended impact on outcomes should be informed by relevant frameworks, models, or theories.

Recommendations of Cancer Moonshot Blue Ribbon Panel: To address the population impact of suboptimal rates for CRC screening and follow-up care, the Cancer MoonshotSM Blue Ribbon Panel Implementation Science Working Group recommended a strategic investment in the development and testing of implementation strategies to significantly improve CRC screening and follow-up rates, particularly among traditionally underserved populations. Specifically, the working group recommended research to: 1) identify, understand, and develop multilevel interventions for increasing CRC screening and follow-up of positive test results; and 2) disseminate effective multilevel interventions to other CRC programs. The workgroup noted that this research could help to accelerate the implementation of additional population-level cancer prevention and control recommendations.

This FOA supports research to pilot test, refine, and examine the impact of a multilevel intervention on rates of CRC screening, follow-up, and referral-to-care.

Applicants responding to this ACCSIS UG3/UH3 FOA (RFA-CA-19-018) are expected to familiarize themselves with FOA (RFA-CA-17-039) for the ACCSIS Coordinating Center. As the UG3/UH3 awardees will interact closely with the ACCSIS Coordinating Center, the applicants responding to this FOA need to understand the role and responsibilities of the ACCSIS Coordinating Center.

Expected Characteristics of Proposed ACCSIS Research Projects

The following are characteristics expected to be included in the proposed ACCSIS Research Projects in the UG3 Planning-Exploratory Phase (Year 1) and the UH3 Implementation Phase (Years 2-5). The proposed research study should be explained in sufficient detail in the Research Strategy section and delineated by phase.

• The region of the U.S. should include individuals for whom CRC screening rates are below or well-below national standards and address cancer health disparities by including traditionally underserved target populations or target populations for whom rates are disproportionately lower than national standards (e.g., racial and ethnic minorities, populations residing in rural areas, low-income populations, marginalized populations);
• The region should cover a sufficient geographic area (e.g., neighborhoods, cities, counties, states) such that the multilevel intervention would have a substantive impact on rates of CRC screening, follow-up, and referral-to-care;
• Identification of this region should be guided by preliminary data on local contextual barriers and facilitators for increasing rates of CRC screening, follow-up, and referral-to-care;
• The multilevel intervention should be explicitly guided by relevant theories, frameworks, or models;
• The UG3 Planning-Exploratory Phase (Year 1) should include plans for pilot testing and refining the multilevel intervention (e.g., feasibility, acceptability, preliminary outcomes);
• The UH3 Implementation Phase (Years 2-5) should propose an experimental or quasi-experimental study design to test the impact of the multilevel intervention on rates of CRC screening, follow-up, and referral-to-care;
• The experimental or quasi-experimental study design proposed in the UH3 Implementation Phase should include testable hypotheses for how the intervention is expected to change outcomes. It should also include what data will be collected to assess potential moderators and mediators of the multilevel intervention;
• Process and outcome data should be collected at two or more levels;
• Process and outcome data should be collected at three or more time points, including baseline and at minimum a 9-month follow-up time point;
• Outcome data that include (but are not limited to) CRC screening rates among the target population and CRC follow-up rates among individuals for whom the screening test is positive;
• Applicants are encouraged to incorporate elements of pragmatic (vs. explanatory) trials into the experimental or quasi-experimental study design proposed in the UH3 Implementation Phase, including eligibility, recruitment, setting, organization, flexibility (delivery), flexibility (adherence), follow-up, primary outcome(s), and primary analysis. Consultation of the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) may be useful.
• Applicants are encouraged to collect both qualitative and quantitative process and outcome data at multiple levels.

Two-phase Projects

Initial cooperative agreement awards will be granted for a one-year UG3 Planning-Exploratory Phase to demonstrate feasibility, acceptability, and potential for the proposed multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care. The most promising projects may be approved for transition to the UH3 Implementation Phase of the award. The primary focus of the UH3 Implementation Phase is to test the impact of the multilevel intervention on increasing rates of CRC screening, follow-up, and referral-to-care using an experimental or quasi-experimental study design.

Objectives for UG3 Planning-Exploratory Phase:

During the UG3 Planning-Exploratory Phase, investigators are expected to pilot test, measure, and refine the multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care among target populations for whom CRC screening rates are below or well-below national standards and include those for whom rates are disproportionately low. Investigators are also expected to finalize preparation for using an experimental or quasi-experimental study design proposed for the UH3 Implementation Phase. Milestones should be identified to demonstrate readiness to transition to the UH3 Implementation Phase.

The UG3 Planning-Exploratory Phase will focus on two main aspects:

• Conduct a pilot assessment of the multilevel intervention for feasibility, acceptability, and potential for increasing rates of CRC screening, follow-up, and referral-to-care among the target population;
• Refine the multilevel intervention based on pilot data.

Other expectations for the UG3 Planning-Exploratory Phase include:

• Demonstration of a working relationship with partners from healthcare settings where the UH3 study will be conducted;
• Updated power analysis, sample size calculations, and recruitment strategy based on pilot data;
• Refined data collection procedures, measures, and planned analyses;
• Establishment and achievement of milestones to demonstrate readiness to transition to the UH3 Implementation Phase;
• Plans for IRB approval for the UH3 Implementation Phase.

Transition from UG3 Planning-Exploratory Phase to UH3 Implementation Phase:

After administrative review by NCI program staff, successful projects conducted during the UG3 Planning-Exploratory Phase will be prioritized and may be approved for transition to and funding for the UH3 Implementation Phase.

Criteria used to determine which UG3 projects will be continued into the UH3 phase include:

• Successful achievement of proposed UG3 Planning-Exploratory Phase milestones;
• Successful completion of pilot testing of the multilevel intervention;
• Potential of multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care;
• Potential of the plan for successful conduct of using an experimental or quasi-experimental study design to test impact of the multilevel intervention on rates of CRC screening, follow-up, and referral-to-care;
• Detailed transition request for the UH3 Implementation Phase;
• Availability of funds;
• NCI program priorities.

Note: It is anticipated that not all funded projects in the UG3 Planning-Exploratory Phase will be approved for transition to the UH3 Implementation Phase.

Objectives for UH3 Implementation Phase:

The UH3 Implementation Phase must include plans to conduct a clinical trial to test the impact of the multilevel intervention on increasing rates of CRC screening, follow-up, and referral-to-care in regions of the U.S. where CRC screening rates are below or well-below national standards. In addition, the UH3 phase must include plans to identify locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care that may currently be in use or may emerge over time, but for which evidence of their impact on CRC rates has not yet been evaluated.

These locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care may be evaluated during the UH3 Implementation Phase with support from the ACCSIS Coordinating Center pending availability of funds. Locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care are separate from components of the multilevel intervention.

Expected outcomes for UH3 Implementation Phase include:

• Completion of testing the multilevel intervention using an experimental or quasi-experimental study design;
• Completion of all data collection and analyses, including but not limited to hypothesis testing, moderation, mediation, and longitudinal analyses;
• Updated plan for distribution of multilevel intervention components (e.g., materials, manuals, training protocols);
• Identification and evaluation of locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care;
• User-friendly guidance documents on best practices for adapting and implementing the multilevel intervention;
• Plans for sustainability of the multilevel intervention.

Non-Responsive Projects

The following types of activities remain outside the scope of this FOA and are non-responsive to this FOA. Applications proposing such activities will not be reviewed.

• Approaches that do not focus on testing and refining a multilevel intervention to increase rates of CRC screening, follow-up, and referral-to-care;
• Approaches that only focus on a single level;
• Approaches that only collect data on a single level;
• Approaches that focus on target populations for whom CRC screening rates are above the national standard;
• Approaches that focus on a relatively small geographic area (e.g., single neighborhood, small town or city, single community);
• Approaches that focus exclusively on a healthcare delivery system.

ACCSIS Trans-Program Activities

The ACCSIS 2 Research Projects UG3/UH3 awardees will be required to interact closely with the ACCSIS 1 Research Projects and ACCSIS Coordinating Center; all ACCSIS Program participants will engage in ACCSIS Program activities, as outlined below.

• Scientific Interactions with ACCSIS Coordinating Center. Each ACCSIS Research Project will collaborate with the ACCSIS Coordinating Center to pilot test, refine, and finalize the proposed multilevel intervention; develop common data elements and measures to be used in all ACCSIS Research Projects; collaborate on writing scientific manuscripts; identify, monitor, and evaluate locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care; and incorporate scientific expertise and input on the development, conduct, and analysis of the experimental or quasi-experimental study design to test the impact of a multilevel intervention on rates of CRC screening, follow-up, and referral-to-care.
• ACCSIS Work Groups. Investigators funded through this FOA will join ACCSIS Work Groups already established by the ACCSIS Program Steering Committee (described below). Members of the ACCSIS Work Groups include investigators from the ACCSIS Coordinating Center, both waves of ACCSIS 2 Research Projects, and the NCI. Work Groups are intended to provide a forum for discussing and advising on topics areas that overlap all ACCSIS Research Projects, including but not limited to the following 4 areas: (1) Implementation Science, (2) Healthcare Systems/Community Partnerships, (3) Ethics/Regulatory/Data Sharing, and (4) Design/Analysis. 

ACCSIS Program Steering Committee

An ACCSIS Program Steering Committee will serve as the governing board of the ACCSIS Program and include representatives from each ACCSIS Research Project funded through RFA-CA-17-038 (first wave) and through this FOA (second wave). For details on the composition and responsibilities of the ACCSIS Program Steering Committee, see Section VI.2 under Cooperative Agreement Terms and Conditions of the 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 from 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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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
• 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 not 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) 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.

An individual serving as a PD/PI on any already awarded ACCSIS Program award (either UG3/UH3 project under RFA-CA-17-038 or U24 ACCSIS Coordinating Center under RFA-CA-17-039) is not eligible to serve as a PD/PI on an UG3/UH3 Phased Award application submitted in response to this FOA.

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.

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

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:

Sarah Kobrin, Ph.D., MPH
Telephone: 301-276-6931
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 exceptions or additional requirements:

For this FOA, the Research Strategy for both phases combined (i.e., UG3 Planning-Exploratory Phase and UH3 Implementation Phase together) is limited to 30 pages.

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

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed. Biosketches should reflect the PD(s)/PI(s) and key personnel's expertise in CRC screening, follow-up, and referral-to-care, health services or healthcare delivery research, multilevel interventions, experimental or quasi-experimental study designs, and implementation science. Research personnel are also expected to have a track-record of conducting studies with multiple stakeholder groups involved in healthcare delivery

All instructions in the SF424 (R&R) Application Guide must be followed. Any individual designated as a PD/PI must commit a minimum of 1.8 person-months effort per year to the project. The PD/PI person-months effort cannot be reduced in later years of the award. If a project includes multiple PDs/PIs, the total annual PD/PI effort must be at least 1.8 person-months and the contact PD/PI effort must be a minimum of 1.2-person months.

Budgeted effort of other personnel must be appropriate to the needs and objectives of the project.

Applications must include a travel budget for several key personnel (e.g., PD[s]/PI[s], program manager, and one or two investigators) to attend an annual 2-day meeting of the ACCSIS Program Committee for the duration of the 5-year ACCSIS Program. Meetings are expected to take place in the Bethesda, Maryland, area.

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: Provide the overall goals for the entire application and indicate separately Specific Aims to be accomplished in the UG3 Planning-Exploratory Phase and the UH3 Implementation Phase.

Research Strategy: Organize the Research Strategy into the subsections identified below.

Sub-section A. Background and Significance

• Define the region of the U.S. that will be the focus of the project. Include local data demonstrating CRC screening rates below or well-below national standards.
• Justify and explain rationale for selection of U.S. region and how it addresses cancer health disparities, including traditional underserved target populations or target populations for whom rates are disproportionately lower than national standards. Examples of regions include but are not limited to neighborhoods, towns, cities, and states where screening rates are low among racial and ethnic minorities, populations residing in rural areas, low-income populations, marginalized populations, and traditionally underserved populations.
• Justify and explain rationale for selection and size of geographic region that will be the focus of the project.

Sub-section B. Preliminary Data

• Summarize preliminary data indicating appropriate selection of proposed geographic region and multilevel intervention components based on local barriers that inhibit the use of evidence-based interventions to increase rates of CRC screening, follow-up, and referral-to-care as well as local facilitators that might support efforts to increase these rates. Preliminary data should be included for each proposed level corresponding to the selection of components for the multilevel intervention. See Key Definitions section for explanation of terms.
• Summarize history of collaboration with proposed stakeholders, including but not limited to patient advocacy groups, healthcare organizations, community-based organizations, local philanthropic organizations, health systems, clinics, health departments, and professional organizations.
• Summarize relevant literature to inform and justify selection of multilevel intervention components for increasing rates of CRC screening, follow-up, and referral-to-care.

Sub-section C. Approach (divided into the UG3 Planning-Exploratory Phase and the UH3 Implementation Phase):

UG3 Planning-Exploratory Phase--address each of the items listed below.

• Description of proposed multilevel intervention components and explanation for why they are appropriate for the proposed study context.
• Linking of conceptual model(s) to multilevel intervention including but not limited to selection of components, process and outcome measures, and proposed analyses.
• Description of proposed pilot study components, including but not limited to setting, target sample size, process and outcome data collection, and analyses.
• Plans for refining the proposed multilevel intervention based on pilot data.
• Plans for transition to the UH3 Implementation Phase.

UH3 Implementation Phase--address each of the items listed below.

• Plans for proposed experimental or quasi-experimental study design, including justification for selection of study design, process and outcome measures, and partnering organizations.
• Detail methods for the proposed study, including target sample size (accounting for reasonable estimates of attrition based on prior related studies or published literature), power analyses, justification for unit of analysis, consideration of clustering effects on sample size calculations and analytic plan, timeline for data collection at a minimum of three time points (including baseline) with a minimum follow-up period of 9-months, selection of validated measurement instruments, and process and outcome data collection and analysis.
• Recruitment and enrollment strategies based on extant literature of best practices and knowledge of local context.
• Detail plans for identifying, monitoring, and evaluating locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care that may currently be in use or emerge during the study but that have not yet been evaluated. Note that the evaluation of locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care will be separate from the main experimental or quasi-experimental multilevel intervention study.
• Plans for revisions to the multilevel intervention and proposal for working with the ACCSIS Coordinating Center to refine and distribute tailored guidance documents (e.g., materials, implementation manual, best practices, summaries, briefs, presentations) to stakeholder audiences to support broader scale-up post-study period (pending supportive outcome data).

Health Disparities. If applicable to the type of research being proposed, address how health disparity populations or data will be integrated into the proposed studies. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. In this context, efforts are encouraged to address the needs of racially/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates.

Sub-section D. Milestones and Timelines

Using separate sub-headings, provide detailed timelines and milestones that are aligned with overall objectives of each phase.:

• UG3 Planning-Exploratory Phase (including specific milestones that will serve as criteria for progressing to the UH3 Implementation Phase); and
• UH3 Implementation Phase.

Their description for each phase must include objective criteria for determining whether a milestone has been achieved.

Annual milestones should function as indicators of a project's progress, will be used to evaluate the application in peer review, and in consideration of funding for the project in non-competing award years.

All milestones should be well-defined and associated with objective evaluation criteria. For all milestones, address the following aspects:

• Provide appropriately detailed criteria that will be used to assess achievement of each milestone;
• Identify any impediments that could require a revision to the research plan, milestones, and/or timeline along with a discussion of alternative approaches.

Letters of Support: Applicants must include letters of support from collaborating entities (e.g., hospitals, clinics, health departments, community-based organizations, etc.).

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Addressing the Cancer Moonshot Public Access Pilot Program: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer MoonshotSM Initiative that requires applicants to submit a Public Access and Data Sharing Plan that (1) describes their proposed process for making resulting Publications and to the extent possible, the Underlying Primary Data immediately and broadly available to the public; (2) if applicable, provides a justification to NCI if such sharing is not possible.  NCI will give competitive preference and funding priority to applications with a data sharing plan that complies with the strategy described here. The data sharing plan will become a term and condition of award.
• The ACCSIS Program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, transparency, and reproducibility. The ACCSIS Program encourages sharing of study data from ACCSIS Research Projects in a timely manner with appropriate privacy and confidentiality protections to facilitate additional research, including but not limited to secondary data analyses, reproducibility of study findings, and additional subgroup, moderation, and/or mediational analyses not including as primary or secondary outcomes in the proposed as part of the trial in the UH3 Implementation Phase. The ACCSIS Program expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these goals.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Provide Study Record for the clinical trial required for the UH3 Implementation Phase.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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 for responsiveness by NCI, NIH. Applications that are incomplete, non-compliant, and/or not responsive will not be reviewed.

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies [GWAS]), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the 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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

For this particular announcement, note the following:

Applications will be assigned a single impact score for the UG3 Planning-Exploratory Phase and the UH3 Implementation Phase.

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 the prior research that serves as the key support for the proposed project rigorous? 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?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific for this FOA: What is the potential of the proposed multilevel intervention to significantly increase regional rates of CRC screening, follow-up, and referral-to-care?

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

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific for this FOA: Is the research team expertise appropriate and sufficiently diverse to manage pilot testing, refinement, and assessment of the impact of the multilevel intervention on regional rates of CRC screening, follow-up, and referral-to-care? For example, does the team include appropriate expertise in CRC screening, follow-up, and referral-to-care; healthcare services or healthcare delivery research; implementation science; multilevel interventions; experimental or quasi-experimental study designs; health disparities; and partnership research? What is the likelihood that all stakeholders will be able to collaboratively work together to complete the proposed multilevel intervention trial?

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?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice

Specific for this FOA: How innovative is the proposed multilevel intervention for increasing rates of CRC screening, follow-up, and referral-to-care? How appropriate is the selection of components of the multilevel intervention based on local data regarding barriers and facilitators of adoption and implementation of evidence-based CRC interventions?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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? 

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific for this FOA: How well does the application address the NCI Cancer MoonshotSM Public Access and Data Sharing Policy? How rigorous and feasible is the plan to pilot test, refine, and assess the impact of the multilevel intervention on regional rates of CRC screening, follow-up, and referral-to-care? How adequate and detailed is the plan for progression from the UG3 Planning-Exploratory Phase to the UH3 Implementation Phase? Does the application propose to conduct an experimental or quasi-experimental study design during the UH3 Implementation Phase?

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?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Milestones

How clearly are the steps and milestones defined? Are the milestones feasible and quantifiable with respect to proposed objectives? Are adequate criteria provided for the UG3 Planning-Exploratory Phase to determine successful completion of milestones? Are the milestones for the UH3 Implementation Phase appropriate?

For research that involves human subjects but does not involve one of the 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 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 individuals of all ages (including children and older adults) 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.

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

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 CSR, 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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.

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.

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:

• Defining the overall research objectives;
• Determining approaches, designing protocols, setting project milestones, and overseeing the conduct of the research in both the UG3 Planning-Exploratory Phase and the UH3 Implementation Phase;
• Overseeing the conduct of the UG3/UH3 ACCSIS 2 Research Project and ensuring its scientific rigor;
• Overseeing the conduct of the identification, monitoring, and evaluation of the locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care;
• Ensuring compliance with the applicable mandatory regulations (including protection of human subjects) as required by specific research activities;
• Adhering to the NIH policies regarding intellectual property, data release, and other policies that might be established during the ACCSIS Program;
• Submitting updates to the ACCSIS Coordinating Center and the NCI on progress and problems;
• Participating as voting member(s) of the ACCSIS Program Steering Committee;
• Implementing guidelines and procedures developed by the ACCSIS Program Steering Committee;
• Participating in teleconferences with NCI program staff, as needed;
• Attending annual ACCSIS Program Committee meetings expected to be held in the Bethesda, Maryland, area;
• Retaining custody of and have primary rights to the data, technologies, and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies;
• Registering any clinical trial studies through ClinicalTrials.gov (http:clinicaltrials.gov).

In addition to standard annual Research Performance Progress Report (RPPR) submissions, PDs/PIs may be expected to supply additional progress-related information to the NCI.

Additional responsibilities include:

• Leveraging, where feasible, technology from related NCI-sponsored informatics initiatives, for example, the NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research.
• Coordinating with and leveraging, where feasible, the technology of the NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact (cbiit.cancer.gov/cancerdatacommons).

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

One or more designated NCI Program staff members will have substantial involvement as Project Scientist(s) for the ACCSIS Program.

Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the National Cancer Institute (NCI) will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act. 

The specific roles of the substantially involved NCI staff members include the following activities:

• Participating as voting members in the ACCSIS Program Steering Committee;
• Advising on innovative approaches for sharing results from the ACCSIS Program to key stakeholder organizations (e.g., professional societies, practice-based organizations, patient advisory groups) in user-friendly formats (e.g., briefs, summaries) that extend beyond the traditional peer-reviewed publications or scientific conference presentations;
• Participating in teleconferences with the PDs/PIs and key personnel of ACCSIS 1 and 2 Research Projects to monitor progress;
• Providing scientific input on the ACCSIS 1 and 2 Research Projects, including pilot testing and refinement of the multilevel intervention; methodological and statistical considerations for the trial; participant recruitment, enrollment, and retention; and data analysis and interpretation of study findings;
• Attending annual ACCSIS Program Steering Committee meetings; expected to be held in the Bethesda, Maryland, area;
• Participating in ACCSIS Work Groups;
• Providing scientific input on identifying, monitoring, and evaluating locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care conducted by each ACCSIS 1 and 2 Research Project and supported by the ACCSIS Coordinating Center; and
• Contributing, as appropriate, to scientific manuscripts and other scientific and scholarly activities (e.g., oral presentations, poster presentations) resulting from the ACCSIS Program.

Areas of Joint Responsibility include:

ACCSIS Program Steering Committee:

This Steering Committee serves as the main governing board of the ACCSIS Program. The ACCSIS Program Steering Committee consists of the following voting members:

• The PDs/PIs from each ACCSIS Research Project award including both the first wave awardees under RFA-CA-17-038 and the second wave awardees under this FOA (one vote per ACCSIS Research Project);
• The PDs/PIs from the ACCSIS Coordinating Center (funded under RFA-CA-17-039) (one vote for the ACCSIS Coordinating Center); and
• The NCI-assigned Project Scientist(s) who collectively will have one vote.

Chair of the ACCSIS Program Steering Committee will be one of the ACCSIS PD/PIs elected by the voting members of the Steering Committee. The chair serve a term of 12-months.

The Steering Committee will meet as needed via phone conference and in person once every year, at locations selected by the Steering Committee in consultation with the NCI.

The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Scientists will serve on such sub-committees as they deem appropriate.

The main responsibilities of the ACCSIS Program Steering Committee will include the following elements:

• Addressing and coordinating aspects relevant to all ACCSIS 1 and ACCSIS 2 Research Projects and the ACCSIS Coordinating Center;
• Developing, as needed, overall policies and processes applicable to all ACCSIS awardees;
• Assisting in dissemination across the ACCSIS Program of policies and processes that enable research in partnership with healthcare systems, their patients, and practitioners.
• Attending annual meetings to review progress across the ACCSIS 1 and ACCSIS 2 Research Projects;
• Discussing approaches for supporting ACCSIS 1 and ACCSIS 2 Research Projects in identifying, monitoring, and evaluating locally-developed innovative approaches to increase rates of CRC screening, follow-up, and referral-to-care;
• Coordinating scientific writing groups for manuscripts and oral and poster presentations at professional societies and scholarly meetings;
• Establishing ACCSIS Work Groups; and
• Stimulating and coordinating communications among awardees (e.g., share ideas, discuss solutions to technical issues, resolve logistical problems).

Dispute Resolution:

Any disagreements that may arise in scientific and/or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting; one NIH designee; and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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.

In addition to standard RPPR, awardees may be requested to supply additional progress-related information in the context of Beau Biden Cancer Moonshot initiative.

A final RPPR, 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, application errors and warnings, documenting system problems that threaten on-time submission, and 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)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

For questions about the healthcare delivery system aspects of the application:

Sarah Kobrin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6931
Email: [email protected]

For questions about the implementation science aspects of the application:

Wynne E. Norton, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6875
Email: [email protected]

Robert Freund, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
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.