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) encourages applications that develop and test multilevel interventions to improve follow-up to abnormal screening tests for breast, colorectal, cervical and lung cancers. Improving follow-up to abnormal screening tests is dependent on factors at the individual, team, healthcare system or community setting levels. Appropriate applications for this FOA should propose to intervene at one or more levels, and must measure outcomes at three or more levels, while accounting for interactions that occur between levels.

Key definitions for the context of this FOA

Multilevel Intervention: An intervention at one or more levels of individuals, healthcare teams, healthcare systems and/or community settings that measures outcomes at three or more of these levels.

Levels include:

• Individuals: Patients, caregivers and family members, clinicians.
• Healthcare teams: Two or more clinicians including primary and specialty care, support staff.
• Healthcare system: Collection of primary and specialty care clinicians and support staff, medical facilities, and organizational structures. Together these people, institutions and resources provide the environment for the comprehensive delivery of healthcare services related to the cancer screening process. Cancer screening is a process which begins with the determination of screening eligibility through treatment of benign precursor or malignant disease diagnosed as a result of screening.
• Community setting: Environments in which the process of delivering healthcare reflects approaches typically followed by clinicians whose primary responsibilities are patient care (e.g., Federally Qualified Health Centers). Patient populations in these environments tend to be more representative of the local population, and may be populations with fewer resources, than those referred to academic medical centers for specialty care, or who are enrolled in clinical trials.

One of the major impediments to health care quality improvement identified by the Institute of Medicine in the 2013 report, "Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis" is the challenge of care at the transitions between types of care, for example screening and diagnosis.

Follow-up of an abnormal screening test: Regular evidence-based screening is associated with decreased mortality from breast, colorectal, and cervical cancer in the general population and from lung cancer in high-risk individuals. Through the treatment of cancer precursors, screening is associated with decreased incidence of cervical and colorectal cancers. Additionally, there is adequate evidence that screening for breast and lung cancers reduces mortality. As a result, the United States Preventive Services Task Force recommends screening for all four cancers in the appropriate populations.

Further, we recognize that screening is a process, not a discrete event, and this provides an opportunity to consider improvements in multiple points along the care process. We can achieve higher rates of mortality reduction by assuring that the complete process of additional testing and evaluation subsequent to an abnormal screening test always occurs, particularly among populations with few resources. The question is how to achieve these improvements.

No national estimates exist of the proportion of individuals without follow-up after receiving abnormal screening tests. While several reviews suggest the rates of incomplete follow-up are high, they also vary substantially among different population groups and different health systems. Failure to follow-up after an abnormal screening test is a problem that limits the effectiveness of cancer screening in general and perpetuates health disparities specifically. Research is needed to increase the completion of diagnostic evaluation after abnormal screening to achieve mortality reduction of cancer screening, and optimize the nation's investment in the delivery of screening tests.

Multilevel interventions: For the purposes of this announcement, multilevel interventions will intervene on one or more levels of individuals, healthcare teams, healthcare systems and/or community settings and will measure outcomes at three or more of these levels. The primary outcome of the intervention is to increase the proportion of individuals receiving abnormal screening test results who complete follow-up evaluations. A multilevel intervention might focus on interrelationships between individuals, healthcare teams and their healthcare system. Hypotheses and analyses should reflect consideration that an intervention on one level can affect factors at other levels, such that implementation of a clinician or healthcare system intervention may have an effect on individuals seeking care.

Identification of factors and measurement at each level: Multilevel approaches must be integrated throughout healthcare systems from top to bottom to impact those with abnormal screening tests. The challenge is to understand how to take advantage of multilevel interventions that consider contextual issues where care is provided so as to facilitate improvements in the quality of care.

Measurements are conceptually distinguished by the level at which they are collected and analyzed. For example, a physician education intervention may be conceptualized and measured in a number of ways. Conceptualized as an individual-level intervention, one might ask a series of questions about individual knowledge, opinions, or actions. Conceptualized as a healthcare system and/or community setting-level intervention, one might ask a series of questions about healthcare system knowledge, opinions, or actions. Conceptualized as a multi-level intervention, one might ask a series of questions about both the individual and healthcare system knowledge, opinions, or actions. To justify the aggregation of responses from each level and to make cross-level comparisons, it is expected that one would have to demonstrate agreement among level members and between-level variance.

This FOA supports development and testing of multilevel interventions to improve follow-up to abnormal screening tests for breast, colorectal, cervical and lung cancers. Examples of what would be considered appropriate for the goals of this FOA include but are not limited to intervening at one or more levels and measuring outcomes at three or more levels while accounting for interactions that occur between levels. Mixed method approaches, while not required may help identify expected and unexpected effects and interactions of multilevel interventions.

• Intervention outcomes should be measured at multiple levels even if the intervention is directed at one level.
• Constructs, measures and interventions should be anchored in a conceptual or theoretical framework.
• Key constructs and measures should be defined by level so that between level intervention interactions may be assessed.
• Complementary measures should be established at the distinct levels.
• Clarification of outcomes is expected for the causal relationships between factors and potential moderators and mediators.
• Randomized trials are preferred, but other designs (e.g., factorial, quasi-experiments, natural experiments, interrupted time-series designs) that assess intervention effects with comparable individuals, healthcare teams, healthcare systems and/or community settings, and across settings that do not receive the intervention will be considered.
• Comparative studies that assess the effectiveness of alternatives are expected.

Examples of appropriate individual research projects that compare intervention effects include but are not limited to the following:

• Single level intervention: Directed at an individual clinician and measures effects of the intervention at three or more multiple levels (e.g., the patient, healthcare team, and healthcare system and/or community setting levels).
• A study might intervene with individual clinicians to understand their role within healthcare teams.
• A study might assess an individual clinician’s contributions to effective teamwork within the context of clinical practice.
• A study may test an individual clinician’s role to deliver follow-up to abnormal testing correctly with a healthcare team, clinical practice or clinic healthcare system.
• Healthcare team level intervention: Directed at healthcare team management and leadership facilitation encourages communication between the referring and diagnostic clinical team.
• A study might evaluate the quality of the healthcare team functioning and the relationship between patient and healthcare team level outcomes that result in follow-up to abnormal tests.
• Healthcare team level intervention: Provides comparison of the effectiveness of patient navigator functions into the healthcare team.
• A study might consider the effects of patient navigation on or within the referring or receiving clinician team.
• A study might consider cost-effectiveness components between primary and multispecialty clinician teams.
• Healthcare system and/or community setting level intervention: Considers how to optimize system-targeted technologies.
• A study of electronic medical records to increase adherence to follow-up of an abnormal test to improve uptake of evidence into clinical decisions.
• A study of centralizing diagnostic and follow-up services (e.g., test ordering and reporting positive screening test results, pathology report, and digital imagery, decision-support systems, telemedicine, referral to diagnostic evaluation, appointment scheduling, follow-up testing, patient adherence, referral to treatment).
• A study of knowledge exchange among healthcare professionals in different healthcare settings.
• Multilevel patient, clinician, healthcare system and/or community setting intervention: Designed to promote follow-up of an abnormal cancer screening test that focuses on the context of care.
• A study of patient and clinician engagement with automated reminders that track completion after a positive diagnosis might include patient navigators to address patient barriers to follow-up.
• A study of technologies to test information flow between primary and multidisciplinary clinicians or systems of care.

Any of the above studies are encouraged to compare interventions in low versus high resource settings. Consideration of the details that make the settings and implementation different are also encouraged.

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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.

Multiple PD/PI applications could have different responsibilities with respect to one or more of the following functions: 1) analysis and metrics, 2) medical care interventions, and 3) behavioral interventions.

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, 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:

Erica S. Breslau, Ph.D., M.P.H.
National Cancer Institute (NCI).
Telephone: 240-276-6773
Email: breslaue@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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. Sites should have a history of successful transdisciplinary and multidisciplinary collaboration.

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

All instructions in the SF424 (R&R) Application Guide must be followed. Key personnel should have expertise in measurement and analysis relevant to the multilevel framework and intervention plan (e.g. individuals, healthcare teams, healthcare system and/or community settings). Key personnel are encouraged to have a successful record of multicenter and multidisciplinary scientific collaboration. Investigators with a record of transdisciplinary collaboration are encouraged.

All instructions in the SF424 (R&R) Application Guide must be followed. In addition, applicants should budget for the full costs of covering expenses of an annual meeting (to be held in the Washington, DC, 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:

Research Strategy: All proposed approaches should include:

• Intervention at one or more levels.
• Hypothesized interactions among levels.
• Measurement of baseline and outcomes at three or more levels.
• Analysis to test for hypothesized interactions.
• Documentation of four endpoints:

1) initiation of the diagnostic evaluation;
2) completion of the diagnostic evaluation;
3) report of results to the referring provider; and
4) report of results to the patient with the abnormal screening test. 

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.

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.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described 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.

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 for this FOA: Will the proposed science contribute to developing the science of multilevel interventions?

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 for this FOA: Do the investigators have a record of successful collaborative work?

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 for this FOA: Is the intervention addressing the problem of follow-up to abnormal cancer screening in new ways? Will the proposed research provide new insights into multilevel effects and interventions?

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 for this FOA: Is there theoretical conceptualization of multilevel effects? Do the intervention and analyses apply concepts from the conceptualization? Are measurements being made at baseline and outcomes accounted for at three or more levels? Are analyses being conducted to test for hypothesized interactions? How likely is the intervention to be adopted in practice?

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 for this FOA: Is the environment supportive of investigators conducting multilevel interventions on healthcare?

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.

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

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

As applicable for the 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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

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

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

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

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

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.

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 (HHS) 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)' Primary Responsibilities

Each of the PD(s)/PI(s) retains the primary responsibility, authority, and dominant role for planning, directing, and executing the activities of the award under this FOA.  The PD(s)/PI(s) assume responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the PDMC U01 award in accordance with these terms and conditions of the award.

Specific responsibilities and rights include:

• Oversee and direct the project as a whole, including the dissemination of approaches, methods, models, software, and tools broadly to the cancer research community. 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.
• Acknowledge the Multilevel Intervention in Cancer Care Delivery (MLI) consortium and indicate the appropriate MLI U01 grant number on all scientific research publications related to the U01 award.
• Work closely with the NCI Program Director or Project Scientist (see below) on the coordination and management of research program activities. These actions involve (but will not be limited to) participation in annual coordinating meetings, working groups, and teleconferences with NCI scientific and program staff and other awarded investigators, as needed.
• Work with NCI scientific staff to define measures of levels, collaborate with other MLI investigators to establish, adapt, validate, share and implement standardized core measures, and to develop and standardize analytic techniques that advance the science of multilevel interventions.
• Serve on the MLICCD Steering Committee. The MLI U01 PD/PI (contact PD/PI for applications with multiple PDs/PIs) is required to serve as a member of the MLI Steering Committee and will collectively have one vote. PD/PI will serve as chairperson of MLI Steering Committee that will rotate on a timely basis among all PD/PI members.
• Ensure that data are shared as appropriate and in accordance with the data sharing plan and NCI policies.

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

A designated NCI Program Staff member, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

Specifically, the NCI Project Scientists will:

• Be an NCI staff member who is selected because of relevant scientific content-area expertise and experience with regard to the scientific goals and objectives of a given U01 award to work with a lead PI. These staff members will have substantial scientific and programmatic involvement as facilitators through technical assistance, advice, coordination, and collaboration above and beyond the levels required normally for program stewardship of grants.
• Review of all major collaborations that the awardee might propose with research groups outside the awardee institution and advise on their appropriateness before implementation to assure consistency with the goals of this FOA;
• Coordinate and facilitate interactions and scientific integration, and collaboration among the MLI U01 awardees and across complementary NCI programs, projects, and centers that use MLI models.
• Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the awardees and between awardees and NCI staff.
• Serve as a voting member of the MLI Steering Committee.
• Assist the Steering Committee to coordinate and co-organize MLI annual meetings, working groups and teleconferences, as needed.
• Assist in avoiding unwarranted duplication of effort with other NCI efforts;
• Suggest post-award modifications to projects when certain objectives of the FOA are not met. Specifically, the NCI Project Scientist may recommend withholding of support, suspension, or termination of a U01 award for lack of adherence to required policies and/or procedures, or failure to comply with the Terms and Conditions of award.

Additionally, an NCI Program Director acting as the NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. A Program Official may also have substantial programmatic involvement (as a Project Scientist) and may be the same person as Project Scientist.

Areas of Joint Responsibility

The NCI Project Scientist and the PD/PIs of the U01 awards funded under the FOA will be jointly responsible for:

• Formation of the Steering Committee (senior representatives of each U01 project, the lead PI, the NCI Project Scientist, and other NCI staff members as appropriate) and defining the membership rules.
• Determining areas of shared research interest for the MLI consortium, development of research priorities and collaborative opportunities, in order to further the goals of the multilevel intervention, as well as other complementary NCI consortia.
• Developing common scientific and administrative policies, guidelines, procedures, best practices for optimizing multilevel interventions, data elements for harmonization, and sharing and dissemination of data and resources as appropriate.

Dispute Resolution:

Efforts will be made to air scientific differences in a constructive and open way to achieve consensus on measures, analytic approaches, and science. Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution, when they cannot be resolve satisfactorily within the structure of the cooperative agreement. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the 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
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Erica S. Breslau, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6773
Email: breslaue@mail.nih.gov

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.gov

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282 
Email: perryc@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.