NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the Multi-Project (M) 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

The P20 mechanism is used to support planning for new programs, expansion or modification of existing resources, and feasibility studies to explore various approaches to the development of interdisciplinary programs that offer potential solutions to problems of special significance to the mission of the NIH. This P20 may lead to center sustainability and/or the ability to be funded through other specialized or comprehensive grants. This Funding Opportunity Announcement (FOA) invites applications to build P20 Centers in the biobehavioral research focused on complex multiple chronic conditions in human adult populations. It is NINR's goal to have P20 Exploratory Centers that are successful in their efforts to: (1) plan and develop sustainable research capacity for nursing science by establishing centralized resources and a research infrastructure; (2) develop the Center’s thematic science area through complementary, synergistic research activities; and, (3) enable research that will develop into new programs of science and independent investigator research applications. This Funding Opportunity Announcement invites applications to establish NINR P20 Exploratory Centers.

The purpose of this program is to support NINR P20 Exploratory Centers to enhance interdisciplinary, biobehavioral research focused on complex multiple chronic conditions in human adult populations.

For this Funding Opportunity Announcement, NINR P20 Exploratory Centers will:

• Develop interdisciplinary, biobehavioral research capacity for scientists conducting human subjects research into complex multiple chronic conditions in adult populations by establishing centralized research resources and a stable research infrastructure.
• Build the Center’s thematic science area through complementary, synergistic research activities.
• Conduct pilot research that will develop into new research teams of the future and independent investigator research applications.
• Support the NINR Common Data Element (CDE) initiative.

It is expected that new biological, psycho-social, and behavioral knowledge will be discovered and the infrastructure will be developed regarding complex multiple chronic conditions in human adult populations within the NINR scientific themes described in the 2016 NINR Mission and Strategic Plan. (https://www.ninr.nih.gov/sites/www.ninr.nih.gov/files/NINR_StratPlan2016_reduced.pdf).

In the United States, more than one in four adults, and two out of three older adults, have multiple chronic conditions (MCC). Multiple chronic conditions are described as two or more conditions lasting a year or longer that limit activities of daily living and/or require ongoing medical attention. Common co-occurring chronic conditions include cancer, arthritis and HIV infections. However, MCC can also include conditions such as, but not limited to: asthma, autoimmune disorders, chronic respiratory conditions, dementia, depressive symptoms, diabetes, heart disease, hypertension, chronic renal or hepatic disease, chronic neurological disorders, obesity, or anxiety.

The risks for adverse health outcomes (e.g., poor functional status, unnecessary hospitalizations, or adverse drug events) increase with the number of multiple chronic conditions present. While more than 25% of adults have at least two co-occurring chronic conditions, the percentage increases to 68 80% in those 65 years and older. Older adults may exhibit three or more chronic conditions, adding to the severity of poor health outcomes, low self-reported health status, high care requirements and increased medication needs.

Multiple chronic conditions are complex, with a range of co-occurring physical, cognitive or emotional symptoms that may contribute to frailty or disability that can directly limit the ability to self-manage. For many, the impact of multiple symptoms can become compounded, resulting in negative effects on quality of life. Further, symptoms associated with MCC can be interdependent, such that the symptoms of one condition can be aggravated by the symptoms, treatments, or medications of another. Due to the potential for these synergistic effects, understanding the complexity of MCC on symptom expression, health outcomes and care burden precludes a focus on a single condition in isolation. Instead, broader attention should be paid to the interactions between and the impact of multiple conditions on health behaviors, lifestyle choices, social supports, prevention and self- management. Knowledge of the integration of biological mechanisms associated with cross-condition symptoms and the identification of potential clusters of interrelated symptoms are also important particularly when the symptoms of a primary diagnosis overshadow symptoms of another condition. For example, heart failure patients have a high probability of a non-cardiac comorbidity that complicates the primary diagnosis of heart disease and management. For these individuals, the presentation of multiple and complex symptoms such as pain, sleep-disturbance, fatigue, or anxiety, among others, may be present. Consequently, coordinated intervention strategies to increase the potential for positive health outcomes are needed. Individuals with Type II diabetes have been reported to have a second chronic condition (e.g., hypertension or obesity) that impacts broader health challenges and requires cohesive strategies for care management. Other MCC appear to cluster in what has been described as biologically and clinically meaningful ways. For example, metabolic syndrome is present when an individual has at least 3 of 5 conditions: obesity, hypertriglyceridemia, low-serum high-density lipoprotein, hypertension, and glucose intolerance. The health consequences of multiple conditions in this syndrome are significant. The complexity of MCC requires effective strategies to identify symptom expression, develop and test new self-management interventions of behaviors across co-occurring symptoms, or new approaches to mitigate further complications. New research is also required to address how a combination of chronic illnesses may influence the overall burden of disease, and how the complexity of these experiences is identified in patients and families living with the challenges of MCC.

As an individual’s risk for adverse health outcomes (e.g., increased symptom burden, impaired functional status, poorer health status, and decreased quality of life) rises with the number of complex multiple chronic conditions, reliance on assistance from caregivers is inevitable. Because individuals with multiple complex chronic conditions (especially those with advanced, serious illness) may be limited in their ability to perform self-management and/or self-care, innovative interventions that incorporate the role of the caregiver are needed. Improved communication of goals, values and preferences in health care decision-making between individuals, families, and their health care providers is necessary to improve understanding of preferences for treatment and care. Intervention strategies are needed to address caregiver needs, skills and competence in caring for individuals with multiple complex chronic conditions.

Research is also needed to address the disproportionate number of minority populations affected by multiple chronic conditions. In the United States, African Americans have higher rates of diabetes, hypertension, and heart disease than other groups; Hispanics and Latinos have almost twice the incidence of diabetes and higher rates of end-stage renal disease caused by diabetes than whites. Despite these data, few studies have addressed MCC self-management strategies that reflect culturally competent care of individuals and families in diverse populations.

The combined effects of increasing life expectancy and the aging of the population undoubtedly will further increase the associated public health burden of complex multiple chronic conditions. Many co- occurring chronic conditions have secondary outcomes that may not relate to the underlying causes or pathogenesis of the primary disease (e.g., falls, cognitive impairment, anemia, malnutrition, polypharmacy, or sleep disorders) yet, these outcomes are clinically relevant to self-management preventative strategies to decrease future risks. Research is needed to address individual and family- centered outcomes that not only identify interrelated symptoms, but also identify interventions that overcome barriers to self-management. New interventions are needed that identify biobehavioral factors that affect self- and caregiver-management or supportive care, and the variables that reduce the burden of illness through self-management and caregiver support. Strategies for self- management of symptoms and promotion of personal health among individuals with multiple complex chronic conditions, including routine health monitoring and condition-specific treatment regimens, are important to mitigate the consequences of existing conditions and support preventative self-care management to reduce risk factors leading to additional chronic conditions. In addition, the incorporation of new technologies into self-care may optimize function or add to detection or prevention. It is important that such strategies maximize symptom management and decision-making in the context of different chronic conditions.

Applications should propose innovative ideas that align with a focus on complex multiple chronic conditions in human adult populations. Ideas should be consistent with NINR's Strategic Plan and thematic areas of science (e.g., Symptom Science, Wellness, Self-Management, End-of-Life and Palliative Care). Applicants are to select a topical area based on a conceptually sound integration of previous or currently funded projects and the objectives of this FOA. In addition, the proposed pilot projects in the application must include a minimum of the three NINR Common Data Elements (CDE) (i.e., the demographic CDE and two of the three assessments of symptoms) specified in this FOA. Although not inclusive of all topics that would be considered responsive to this FOA, applicants are encouraged to review the NINR's Strategic Plan document (https://www.ninr.nih.gov/sites/www.ninr.nih.gov/files/NINR_StratPlan2016_reduced.pdf) and Innovative Questions site (https://www.ninr.nih.gov/newsandinformation/iq) which include examples of areas of scientific opportunity at NINR that might be applied to human adult populations with multiple complex chronic conditions.

This call for P20 Exploratory Center applications focuses on complex multiple chronic conditions in human adult populations.

Applicants must collect NINR-specified demographic Common Data Elements (ethnicity, race, educational level, date of birth, gender) and select a minimum of two (2) of the following three (3) NINR Common Data Elements in all Center-related research:

• Pain
• Fatigue
• Affective Well-Being

Pilot project investigators are also encouraged to collect other data in addition to the demographic and two of the three CDEs listed above, as specifically described at: https:// www.ninr.nih.gov/researchandfunding/available-cdes#.VyudhmMYWFI. All additional CDEs must be relevant to human adult populations and utilize the CDE assessment measures described.

Examples of areas of science that would be considered appropriate in response to this FOA include, but are not limited to:

• Designing culturally appropriate symptom self-management, decision-making strategies, and/or interventions that promote healthy lifestyle choices such as diet, exercise, or primary health care practices in adults with complex multiple chronic conditions.
• Describing the biobehavioral factors that affect self- and caregiver-management in multiple complex chronic conditions.
• Developing, refining and testing theoretical frameworks to promote effective treatment and self- management in multiple complex chronic conditions.
• Designing evidence-based interventions and/or programs that promote optimal management of symptoms of complex multiple chronic conditions (e.g., use of a technology intervention program to improve caregiver-reporting of symptoms in individuals with complex multiple conditions).
• Examining the effect of symptom expression on behaviors in complex multiple chronic conditions (e.g., advance care planning or health-care decision-making).
• Developing, testing and evaluating interventions to facilitate self-management priority setting for both individuals with complex multiple chronic conditions and their caregivers.
• Improving the communication of an individual goals, values and preferences regarding advance care planning or health care decisions to families and health care providers. Increasing caregiver understanding of these individual preferences and enhancing skills in advocating for the individual with multiple complex chronic conditions.
• Identifying strategies for self-management of symptoms and promotion of personal health among individuals with multiple complex chronic conditions, including routine health monitoring and condition-specific treatment regimens.
• Improving knowledge of biological mechanisms associated with symptoms and clusters of interrelated symptoms in complex multiple chronic conditions.
• Describing the impact of different comorbidities on the symptom experience and/or on disease trajectories.
• Developing, testing and evaluating tools and interventions to help individuals with complex multiple chronic conditions and their caregivers with medication management including adherence to complex medication regimens, recognition of adverse effects, and decision-making regarding "as needed" medications.

One of the primary objectives of the P20 Centers is the development of sustainable research infrastructures and centralized resources in support of research programs. In addition to collaborations between scientists within an institution, P20 Centers are encouraged to foster interactions and collaborations between investigators at multiple institutions and/or across NINR P20 Centers, to promote a multifaceted approach toward a common goal. An NINR P20 Exploratory Center must be an identifiable unit within a College/School of Nursing (CON/SON). Applications must demonstrate a strong base of successful external research funding (NIH, Federal and/or non-Federal) that is related to topical areas associated with multiple complex chronic conditions.

Centers should identify one or more central themes or focus areas that link Center investigators and their research programs with the objectives of this FOA. Center PD/PIs and Core Faculty must demonstrate a consistent record of NIH funding (R-series, P-series) award to show the capacity for advising new and early stage investigators and post-doctoral fellows.

The organization and structure of the P20 Exploratory Centers must reflect the goals of the Center, encourage collaboration, develop and implement Center-wide research initiatives, promote the use of shared resources and Pilot Program funds, and contribute to the NINR Common Data Element (CDE) initiative. The structure will be determined by the applicant and must contain the following components:

• Administrative Core
• Pilot Administrative Core
• Pilot Projects
• Enrichment Program

Additional Optional Cores may be included. The Optional Cores may change as needed based on new scientific opportunities and partnerships.

NINR P20 Exploratory Center applications must include an Administrative Core that will be responsible for allocation and oversight of Center resources. The Administrative Core is expected to ensure the coordination and integration of Center components and activities. The Administrative Core must have a process to: a) Evaluate the productivity, effectiveness, and appropriateness of Center activities; b) Determine criteria and for Center affiliations (e.g., Center Faculty, Members, Affiliates, etc.); and, c) Foster collaborations and scientific opportunities. All P20 Centers are required to maintain a separate web page within the respective College/School of Nursing (CON/SON) or institutional website with the Administrative Core taking primary responsibility for its creation and maintenance.

The P20 Center Director(s), who is the Program Director/Principal Investigator on the P20 application and the Director of the Administrative Core, must be a nurse scientist and hold a research doctorate degree. The Director must have a demonstrated record of effective administrative and scientific leadership, and proficiency in managing a large, multi-component project. The applicant must also be a faculty member or senior investigator of equivalent rank at the applicant College/School of Nursing. The Director will be responsible for the organization and operation of the Center and for communication with the NINR on programmatic matters. NINR P20 Center PD/PIs are required to attend and to budget accordingly for the annual Center Director's meetings to be held at a location to be determined by the NINR (See Section IV. for details). One or more Associate Directors should be named who will be involved in all aspects of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place that would be used to recommend a permanent successor to the Director, if needed.

The Pilot Administrative Core is responsible for the overall management of all Center pilot projects. A particularly important role of the Pilot Administrative Core is to facilitate pilot investigator career development and transitioning of pilot project data into competitive NIH grant applications and funding. The Core: 1) solicits, selects, and supports pilot studies that advance the Center’s research in complex, multiple chronic conditions; 2) coordinates pilot investigator oversight; 3) guides translation of pilot project results through fostering interdisciplinary communication and collaboration between supported pilot project investigators and other NINR Centers; 4) organizes common measurement and analysis strategies and collaborates with other NINR Centers in research activities, including data harmonization of pilot project data using the NINR Common Data Elements (CDEs); and, 5) monitors and tracks the progress of pilot project success and evaluates the career development of pilot investigators and subsequent NIH grant funding. The pilot project program, administered through the Pilot Administrative Core, provides modest support for pilot studies. This program is directed at new and early stage investigators, and post-doctoral fellows (https://grants.nih.gov/grants/new_investigators/#definition). Efforts to increase the number of pilot project awards and availability of funds for the program using program income or alternative funding sources are particularly encouraged.

Each Center must complete at least five (5) pilot studies during the period of the P20 award. At least two (2) pilot projects must be detailed in the application and these projects must be started in the first year of the award. Details about pilot projects can be found in Section IV. A proposed pilot must: 1) be a human subjects study, 2) lead to NIH applications for an R-series (R15, R21, R01) award, 3) be related to complex multiple chronic conditions in human adult populations and, 4) document the integration of collected NINR CDEs. The specific aims of the proposed pilot cannot include overlap with currently funded projects.

Continued and coordinated professional development and scientific enrichment are critical to keeping the Center members, pilot investigators, and staff aware of new scientific advances, use of new technologies, methodologies and other science-related skills. The P20 Center Enrichment Program, as part of the Administrative Core oversight, is responsible for planning and organizing the various seminars, guest speakers, visiting scientists, consultants, and workshops including notification of these meetings to all Center and pilot project investigators. Staff schedule the agenda of meetings between Center members and the visiting lecturers and coordinate travel plans and expense accounts of the speakers. The Program will expand the research environment and network of investigators focused on MCC research by bringing the scientific progress of pilot and other Center supported studies to the attention of other investigators with the potential to contribute to Center research initiatives. All Enrichment Program activities must be designed to: advance nursing science in complex multiple chronic conditions in human adult populations; support scientific exchange among investigators with research interests in these topic areas, and facilitate interactions between Center scientists and investigators from other fields with relevant expertise. In all cases, the Enrichment Program will further the overall aims and objectives of the Center and its Cores.

Optional Cores may be proposed that provide shared, specialized technical resources and/or expertise that enhance the efficiency, productivity, and interdisciplinary nature of research performed by Center-affiliated investigators. The goal of the Optional Cores is to make technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in complex multiple chronic conditions and other related research areas. Moreover, Optional Cores are intended to facilitate biologic, clinical, and translational research to accomplish the stated goals of the individual Center and of the overall NINR Centers program. Each Optional Core should provide services to multiple, funded research projects.

Justification for proposing an Optional Core: The establishment and continued support of Optional Cores within a Center are justified based on use by independently-funded Center investigators. The minimum requirement for establishing a Core is significant usage by two or more investigators. While investigators holding awards from the Center Pilot Program are appropriate users of the Optional Core facilities, their use does not contribute to justification for establishment or continued support of a Core. Additionally, the minimum of two independently-funded users does not in itself provide sufficient justification for proposing an Optional Core.

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:

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
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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) (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.

The applicant must be a nurse scientist and hold a research doctorate degree. The applicant must also be a faculty member or senior investigator of equivalent rank at the applicant College/School of Nursing. Because a NINR P20 Exploratory Center has a large and complex administrative structure, the PD/PI must have strong leadership abilities and demonstrated proficiency in managing large, multi-component programs. The Center PD/PI should be an experienced and respected scientist with a proven track record (e.g., NIH R01, P01 or U-series awards or other significant peer-reviewed funding) for obtaining NIH funding. The PD/PI must be able to coordinate, integrate, and provide guidance in the establishment of new programs in nursing research. If there are multi-PDs/PIs the contact PD/PI must be a nurse scientist and hold a research doctorate degree.

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).

Applicant organizations with current P20 or P30 Center awards from NINR are only eligible to apply to this FOA if, at the time of application, their total period of Center support is less than 10 years and they have a research focus on multiple complex chronic conditions in human adult populations.

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Weiqun Li, M.D.
Chief, Scientific Review Branch'
Telephone: 301-594-5966
Fax: 301-480-8260
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Administrative Core)	12
Pilot Admin Core (use for Pilot Administrative Core)	12
Project (use for Pilot Projects)	6
Enrichment Program	6
Core	6

Additional page limits 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 a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required; maximum of 1
• Pilot Administrative Core: required; maximum of 1
• Pilot Projects: minimum 2, maximum 2
• Enrichment Program: required; maximum of 1
• Core: Optional; maximum of 1

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Project Summary/Abstract: Describe the scientific theme(s) of the P20 Exploratory Center and the need for a Center. Include the number of Center personnel (e.g., Center Faculty, Members, Affiliates, etc.) and the overall direct costs available in the research base at the College/School of Nursing (e.g., the funded research projects in the College/School of Nursing at the time of the application). Provide a brief overview of the research base at the College/School of Nursing as it relates to the themes of the proposed Center and the FOA, as well as an overview of the Center structure including the Pilot and Enrichment Programs and any Optional Cores.

Project Narrative: In 1-3 sentences describe the relevance of the research to be supported and facilitated by Center activities (Admin Core support, Pilot Admin Core, Pilot Projects and Enrichment Programs) on public health.

Facilities and Other Resources: Describe the existing environment and facilities available to the Center and the process including fee structure to access facilities. The Institutional Commitment at the applicant institution will be a major consideration in ensuring the goals of the Center. The parent institution should recognize the Center as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center.

The parent institution should provide assurance of its commitment to continuing support of the Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place. In addition, it is expected that the Institution will support the goal of providing priority access to Institution’s and Center’s facilities and services to Center personnel at minimal or reduced cost.

Equipment: A general listing of major, shared pieces of equipment to be used by Center members should be provided. Note: Specific Optional Core facilities, equipment, and special resources should be listed in each proposed Optional Core component.

Other Attachments: Grant Support: Please title this attachment "Active Grant Support" and list all Federal and non- federal grant support for the Center investigators. Complete and organize alphabetically by the last name of the Center investigator who is listed as the Program Director/Principal Investigator (PD/PI) on the grant. Include Supporting Organization/Grant Numbers, Complete Grant Title, Project Period, Annual Direct Costs). Applicants are strongly encouraged to provide this in a table format. The attachment should include, in order: Related Current Grant Support, Other Grant Support and Pending Grant Support. The 'Related Current Grant Support" table should include a brief explanation of how each project relates to multiple chronic conditions in human adult populations. 'Other Grant Support' should include infrastructure/services grants (other Centers), and other grants that support multiple chronic condition research in human adult populations, but would not be direct users of Center services.

Description of Potential Pilot Project Investigators: Please title this attachment "Description of Potential Pilot Project Investigators" and organize alphabetically by the investigator's last name. Provide a narrative description of not more than one page per investigator; try to limit each to less than one page. These narratives should include any active federal, foundation or institutional grant number(s), title(s), and a few descriptive sentences of the investigator’s research projects. A brief description of the investigator's current career level (post-doctoral, Early Stage Investigator, New Investigator, etc.). Brief descriptions of completed and ongoing research projects, including grant proposals and peer-reviewed publications submitted based on the projects must be included. The relationship of these projects to research concerning complex multiple chronic conditions in human adult populations should be described, if it is not clear from the project title and description.

Center Collaborations: Please title this attachment Center Collaborations and organize alphabetically by name. List all individuals affiliated with the Center. Provide primary Department Affiliation, key words for research interests, names of other Center members who are collaborators (through publications, grants or research projects), the number of collaborative publications (only those relevant to the Center), and how their work relates to the theme of the Center and the objectives of this FOA. Applicants are strongly encouraged to use a table format.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. The experience of the PD/PI in managing large, multi-component programs should be highlighted along with their history as an administrator and in conducting research..

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Describe the overall specific aims of the Center.

Research Strategy:

Applicants responding to this FOA must thoroughly and comprehensively address the purpose of the NINR P20 Exploratory Center and the objectives listed in Section I. The research strategy should:

• Describe the need for the P20 Center, the scientific rationale underpinning the theme and how the Center will address the topic of complex multiple chronic conditions in human adult populations.
• Describe the unique contribution or the significant gap in the area of complex, multiple, chronic conditions in human adult populations.
• Describe the strategy by which the goals of the Center will be met.
• Describe the structure of the Center, including:
• An internal Executive Committee, consisting of the heads of all proposed Center Cores and Programs, and appropriate business official(s), should be established to assist the Center PD/PI in the allocation of Center resources, the identification and selection of key personnel, and the planning and execution of Center activities. Other members may be added to the Executive Committee at the Director’s discretion.
• An External Advisory Committee (EAC) of scientists and administrators, should be established and should meet in the first year of the award, prior to the first Research Performance Progress Report (RPPR). The EAC should be composed of at least two (2) scientists from outside the applicant organization, with expertise and experiences relevant to the scientific program of the Center. This committee should be used in evaluating the overall research programs of the Center, the development and utilization of research resources, the effectiveness of communications within the Center, and any activities in which problems arise for which expertise is required or desirable. The EAC should meet in person at least once annually. The minutes of the meeting of the EAC, as well as a response from the Center PD/PI concerning EAC meeting recommendations must be submitted to the NINR Program Officer within 30 calendar days of the EAC meeting.
• Describe the coordination among the Administrative Core, the Pilot Administrative Core, the Pilot Projects, the Enrichment Program, and any optional Core?
• Provide a justification for each component in terms of the overall goals of the Center.
• State how Center resources will provide a unique contribution to the research infrastructure at the applicant College/School of Nursing.
• Will the plans, as proposed, bring investigators into the Center from within and outside the institution?
• Does the Center take advantage of the capability of its research base to maximize scientific productivity, particularly through interdisciplinary coordination and collaboration?

Protection of Human Subjects: Describe fully the general principles and policies that will apply to protection of human subjects for the Center. List all components of the application that involve human subjects. Describe general procedures for developing data and safety monitoring plans for NIH defined clinical trials, and notification of NINR staff consistent with NIH and NINR policies for human subjects and clinical trials. Procedures for human subjects protection that are specific to individual cores should be described in those respective sections of the application. Procedures for human subjects' protection that are specific to a pilot project should be described in the appropriate Pilot project component. IRB approval is required for the overall Center data safety and monitoring plan (DSMP) as well as for the DSMP of each individual clinical trial pilot.

Letters of Support: Overall letters of support should be obtained from individuals and institutions providing resources to the Center. Letters from the Institution, Dean of the College/School of Nursing and the External Advisory Committee members must be included. The letter of support from the Institution should include the commitment to continuing support of the Center in the event of a change in Directorship.

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. Plans for submitting all CDE data in the NINR/NIH Data Repository (https://cdrns.nih.gov/) and making these data available for sharing, if requested, are expected to be described.

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.

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Center Director (PD/PI) must also be the Administrative Core Director.
• The complex nature of administrative requirements of Centers will necessitate the assistance of a person with business management expertise. It is important that such an official is identified and is directly involved with the fiscal aspects of the application and grant. An appropriate amount of this individual's time and effort should be committed for this purpose. The institutional business official should be a member of the Internal Center Executive Committee. While budget formulation and planning will undoubtedly begin with the Director in collaboration with the scientific staff, the business official should be involved in the process, provide consultation in matters of fiscal administration, and evaluate such issues as equipment on hand versus that requested for the Core facilities. Additionally, this institutional official can assist the Center PD/PI in determining the compliance with NIH research guidelines.

Budget forms appropriate for the specific component will be included in the application package.

• The Administrative Core Director must contribute no less than 1.8 person months out of 12 months (15% time and effort) to the Core’s activities.
• The Administrative Core budget must include travel expenses for the Center PD/PI(s), other Center Directors (as necessary) and the current Pilot Investigators (as necessary) to attend each annual NINR Center Directors' Meeting.
• The Administrative Core budget must include travel expenses for the External Advisory Committee (EAC) members to attend the annual EAC meeting.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Clearly state how the Administrative Core will contribute to the goals of the Center and outline interactions of the Administrative Core with each of the other Cores. Provide an overview of how the Administrative Core will set the overall direction of the Center and ensure optimal utilization of Center resources.

Research Strategy:

The Administrative Core plays a key role in the coordination and functioning of the Center. Therefore, it should manage the overall activities of the Center, including developing, promoting, and managing use of Center resources.

The Administrative Core must contain the following:

• A general description of activities and institutional support of the Center.
• A presentation of the administrative structure. Include the role of the Administrative Core in 1) establishing and maintaining all collaborations, and 2) working with the institution and local regulatory bodies to ensure that the research complies with appropriate regulations and guidelines governing studies involving human subjects research.
• A description of how the Administrative Core will ensure the synthesis of findings and activities from research projects and cores towards solving the central problem proposed by the Center.
• A process must be in place, and should be described in the application, that would be used to recommend a successor to the Director, if needed.

The Administrative Core must describe how they will meet their responsibilities to:

• Review utilization of funds, including funds for pilot projects, the Enrichment Program and other Center activities, and assure the appropriate expenditure of funds.
• Optimize the utilization of the shared resources of the Center, such as all Core resources.
• Develop and execute a Center evaluation plan that includes ongoing evaluation of all Center activities.
• Develop and execute a sustainability plan that includes ongoing evaluation of the progress toward: 1) Outcomes for sustaining science and infrastructure including leveraging additional research grants and products; 2) Outcomes for sustaining infrastructure including leveraging resources for short-term continuation such as a business model approach, development of an effective budget model, cost sharing, partnerships with other Centers and, 3) Outcomes for sustaining science including publications, presentations, policy briefs, measurement methods and scientific methods.

The organization of the Administrative Core must encompass a supportive structure sufficient to accomplish the following:

• Coordinate and integrate the Center components and activities.
• Review the utilization and quality of Core resources.
• Review utilization of funds, including funds for pilot projects and other Core(s) activities, and assure the appropriate expenditure of these funds.
• Establish a Center web page, with the Administrative Core taking primary responsibility for its development and maintenance.
• Plan for the sustainability of the Center after the period of support is completed, including development of collaboration(s) and preparation for seeking NIH R-series (R15, R21, R01) support and other federal or private research funding.
• Oversight of the internal Executive Committee.
• Oversight of the External Advisory Committee (EAC). The EAC should meet in person at least once annually. Each EAC meeting will have an appointed Chair.

The minutes of the meeting of the EAC, as well as a response from the Center PD/PI concerning EAC meeting recommendations, must be submitted to the NINR Program Officer within 30 calendar days of the EAC meeting.

The Center PD/PI and other Center leaders, as the Director deems appropriate, are responsible for the Evaluation Plan.

Annual planned evaluation of goal attainment, reporting, and subsequent action, if needed, should be described. Because of this guidance and the need of Centers to ensure their own success, a plan for ongoing evaluation of progress toward meeting the aims and goals of all pilot projects, and the overall Center is required. This plan should include the specific criteria and methods that will be used for the evaluation.

The Evaluation Plan should include:

• The specific criteria and methods that will be used for the evaluation.
• A plan for collecting data to evaluate progress. Specify the types of evaluation information that will be submitted in the Center's annual progress report. At minimum, the plan should include the following information for evaluation that will be submitted with the Center's annual progress report to the NINR: federal and non-federal grant applications and peer-reviewed publications from pilot PIs, presentations of pilot results, products, and new partnerships with other Centers.
• Measurable goals for each project year relating to progress of each Core, pilot projects, Programs, collaborative research activities, dissemination and impact of knowledge gained from pilot projects, and efforts to facilitate sustainability.
• A plan for evaluating success, which must include: maintaining a detailed record of the pilot projects, grant submissions and funding resulting from Center activities, peer-reviewed publications, and oral and poster presentations derived from Center activity and funding, and collaboration by Center investigators with other schools and institutions.
• An accounting of resources and resource utilization, as well as efforts taken to maximize the research utilization of these resources.
• A section addressing sustainability of the Center and its research, including plans for attracting new investigators and resources into Center research activities.
• An annually updated plan that addresses and incorporates the suggestions of the External Advisory Committee, as appropriate, for the success and sustainability of the Center.
• An annual evaluation of Center success, based on the NINR Logic Model of Sustainability as outlined in the published NINR Centers of Excellence: A logic model for sustainability, leveraging resources and collaboration to accelerate cross-disciplinary science. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4253141/. See Section PHS 398 Research Plan (Administrative Core) for examples of appropriate measures of sustainability for P20 Exploratory Centers.

The final administrative structure of the Center will be left largely to the discretion of the applicant institution. However, experience has demonstrated that the effective development of the Center programs requires close interaction between the Center PD/PI, Core Leaders, appropriate institutional administrative personnel, and the members of the community in which the Center is located. Therefore, the Center should establish an administrative structure that will permit the development of such interactions.

Letters of Support: Letters of support should be obtained from those providing resources to the administrative core.

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. Plans for submitting all CDE data in the NINR/NIH Data Repository (https://cdrns.nih.gov/) and making these data available for sharing, if requested, are expected to be described.

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 preparing your application in ASSIST, use Component Type Pilot Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Pilot Administrative Core Director' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Pilot Administrative Core Director must be a nurse scientist, hold a doctorate from a research training program and be a faculty member or senior investigator of equivalent rank at the applicant College/School of Nursing.
• The experience of the PID/PI in overseeing the selection and management of delayed onset awards should be described.
• The experience of the PD/PI in advising nurse scientists should be described.
• Pilot project Investigators will be listed in the appropriate pilot project Component.
• The Center Director (PD/PI) and any of the Core Directors may not serve as a pilot project Investigator.

Budget forms appropriate for the specific component will be included in the application package.

Pilot project funds cannot be used to supplement research that has already been funded, regardless of the source.

Efforts to increase the number of Pilot awards and availability of funds for the program using program income or alternative funding sources are particularly encouraged.

Personnel: This category should include salary support for key personnel, including the Pilot Administrative Core Director, and other professional and administrative personnel. The Pilot Administrative Core Director must devote a minimum of 0.6 person months out of 12 months to the Program to ensure adequate oversight. The salary amount charged to the NINR Center of Excellence grant for the Pilot Administrative Core Director, must be commensurate with the time spent on Pilot Administrative Core activities and is subject to institutional and NIH salary policies.

Consultants: Include costs associated with consultants (e.g., consultant fees/honoraria, per diem, or teleconferences) when their services are required by the Pilot Administrative Core, such as external reviewers for Pilot applications.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims:

Describe the aims of the Pilot Administrative Core. The Pilot Administrative Core must include a description of support for 1) supervised investigator research pilot projects, 2) administration of the pilot project program, 3) pilot project oversight and, 4) assistance to the Administrative Core regarding evaluation of the pilot projects program. The Pilot Administrative Core facilitates the selection, planning and oversight of all pilot projects funded under the Center grant mechanism. The Core organizes common measurement and analysis strategies and collaborates with other NINR Centers in research activities, including data harmonization of pilot project data using the NINR Common Data Elements (CDEs). The Core provides biostatistics and methodology support to pilot projects. The Pilot Administrative Core will ensure the appropriate advising and oversight of pilot project PIs with the goal of guiding them toward independent research careers. The application should describe the Center's process for the selection, award, and oversight of all pilot projects as well as the advising and oversight of pilot PIs.

Research Strategy: Each Center may determine their administrative framework for management of the pilot projects program, but certain minimal requirements must be met. Please describe how the major responsibilities of the Pilot Administrative Core will:

• Prepare and ensure appropriate distribution of announcements of the availability of pilot project funding to appropriate potential applicants.
• Arrange and preside over the scientific merit review of pilot proposals. This may be carried out by the internal Center Executive Committee, the External Advisory Committee, by an ad hoc Review Committee, in person or by mail, or with a combination of methods. At least two scientists with expertise relevant to the scientific area of inquiry including at least one reviewer from outside the parent institution must be used for each proposal. All reviewers should assign impact scores in accordance with the NIH system. Copies of all the proposals with written documentation of their reviews, impact scores, and final action must be retained by the Center.
• Assure that advising and oversight plans are followed for all pilot studies and evaluate the effectiveness of the advising and oversight plan in preparing the pilot investigator for an independent research career.
• Maintain oversight and review of progress for ongoing pilot studies.
• Keep appropriate records for all pilot projects with Human Subjects.
• Provide support to the pilot project investigators to facilitate the completion of annual progress reports on pilot project activity.
• Guide the translation of pilot project results developed within this Core into interventions that will foster interdisciplinary communication and collaboration between supported investigators and participants in other Center Cores.
• Facilitate pilot project investigator presentations of pilot research at local and national forums, connecting nationally with others whose interests intersect with pilot investigators, and encouraging discussion of potential applications of the pilot studies.
• Make recommendations to the Center Executive Committee for final pilot project funding decisions and retain a record of funding actions.
• Make recommendations regarding termination or other actions of pilot projects to the Center Executive Committee.
• Maintain records of the outcome of Center pilot project success (e.g., pilot PI applications for federal and non-federal funding, peer-reviewed pilot project-related publications, pilot PI presentations, pilot investigator promotions, etc.).
• Serve as a resource for the Center regarding training opportunities for the Center CON/SON and research community and provide this information to NINR in the annual reports and to reviewers at the time of the renewal application.

All applicants should:

• Describe how the above requirements will be met.
• Describe the plan for administration of the NINR Common Data Elements information required for each pilot.

Two pilot projects should be selected to begin in the first year. These should be the best applications received by the Center and should be reviewed in the manner proposed for all future Pilot applications.

Since pilot projects can be awarded for varying periods of time, these studies may end at various times. In addition, the studies may also be terminated by the Center administration before their approved time limit for various reasons: e.g., (1) the investigator has received outside funding for the project; (2) the project was found not to be feasible; or, (3) the investigator has left the Center institution. When this occurs, the Center PD/PI must contact the NINR Program Officer. Prior approval must be requested from NINR to make new awards for pilot studies with the remaining funds.

Common Data Elements: NINR encourages the use of Common Data Elements (CDE) in basic, clinical, and applied research, patient registries, and other human subjects research to facilitate broader and more effective use of data, and to advance research across studies. CDE are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDE can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. For the purposes of this FOA for P20 Centers, the NINR Common Data Element initiative "demographic" CDE (ethnicity, race, educational level, date of birth, gender) must be used in all Center pilot studies, along with a minimum of two (2) of the following Common Data Elements:

TOPIC	CDE
Pain	PROMIS-Pain
Fatigue	PROMIS-Fatigue
Affective-Well Being	Psychological Well-Being Scale SF-36

This list does not preclude the collection of additional NINR Common Data Elements that would be necessary for the outcomes of the proposed studies or other measures.

The applicant should describe the plan for administration of the Common Data Elements information required for the pilots.

Letters of Support: Letters of support should be obtained from consultants and pilot project reviewers who will be providing services to the Pilot Administrative Core.

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. Plans for submitting all CDE data in the NINR/NIH Data Repository (https://cdrns.nih.gov/) and making these data available for sharing, if requested, are expected to be described.

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 preparing your application in ASSIST, use Component Type Project.

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

Provide relevant information on at least the first two proposed projects, in separate Pilot Project components.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Pilot award eligibility and related guidelines:

• Investigators eligible for pilot funding must be nurse scientists and have an appointment with the College/School of Nursing and include:
• New and early stage investigators without current or past individual NIH research support as a PD/PI (e.g., individual NIH K-awards or R-series awards). Investigators who have been funded on NIH R34, R41, R42, R43 or R44 awards are eligible as pilot investigators. Current or past support from other sources should have been less than the expected budget for an R01 award.
• Post-doctoral fellows in the College/School of Nursing with a designated advisor and appropriate advising and oversight plan.

Up to $50,000 in direct costs per project, per year for up to two years can be budgeted for each approved pilot project. The amount for the pilot projects should be budgeted as an annual lump sum for all years of the award to accommodate the additional pilot projects, which will be implemented in future years as delayed onset awards.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe the specific aims for a specific pilot project. Pilot projects should be appropriate to the overall specific aims of the Center.

Research Strategy: A proposed pilot study should be a discrete, well-defined project that can realistically be completed in two years or less and that requires limited levels of funding. The pilot proposal should clearly delineate the question being asked, detail the procedures and approaches to be followed, and discuss how the data will be analyzed. It must be on a topic related to the objectives of the Center and of this FOA. Projects should be focused, with sample sizes that are statistically justified and with reasonable accrual success within the time constraints of a pilot study and within the level of funding support. Pilot projects may not include:

• Secondary analysis of existing data
• Development of research methodology
• Development of new research technology

Principal Investigators who have current or past funded NINR P20/P30 pilot projects are not eligible...

Applications must propose a minimum of two (2) pilot projects to be started during the first year of award. New projects should be developed each year with a minimum of two (2) ongoing projects per year and a minimum of five (5) pilot projects over the course of the award. It is anticipated that up to $50,000 in direct costs per year for up to two years will be provided for the approved pilot projects (total of up to $100,000 in direct costs over 2 years). Pilot awards are not intended to serve as 'bridge' funding for established nurse scientists who may be experiencing a gap in research funding. Details about appropriate pilot projects are listed below under PHS 398 Research Plan (Pilot Project), Research Strategy.

Each pilot project must follow these guidelines:

• The theoretical or conceptual basis for the pilot study must be clearly explicated.
• An interdisciplinary approach is required to promote the collaboration of nurse scientists with scientists of other disciplines as appropriate.
• For investigators without current or past NIH research support as a PD/PI, a mentorship plan should be described. The advising and oversight plan plan should be more extensive for post-doctoral investigators and should include instruction and oversight in the conduct of research, as well as the science. The advising and oversight plan should extend to include advising the pilot investigator through the submission of a subsequent NIH RPG funding application. The advising and oversight plan should include a communication plan.
• The application must indicate how the proposed pilot study is relevant to research on complex multiple chronic conditions in human adult populations and to the specific aims of the Center.
• Each pilot study proposal should state clearly the justification for eligibility of the investigator under the criteria stated in Research & Related Senior/Key Person Profile (Pilot Project) above.
• A timeline for each pilot project should be included.
• Describe which of the NINR CDEs will be used. The pilot should include the use of NINR demographic CDEs and at least two of the three CDEs outlined in the FOA (PROMIS-Pain, PROMIS-Fatigue, Psychological Well-Being Scale, SF-36.

Pilot projects selected after the Center Grant is awarded require prior approval by NINR prior to initiation (see the NIH Grants Policy Statement 8.1.3 Requests for Prior Approval and https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-129.html for instructions on submitting a request).

Letters of Support: Letters of support should be obtained for each specific pilot project. A letter of support from the Pilot Investigator's supervisor is strongly recommended.

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. Plans for submitting all CDE data in the NINR/NIH Data Repository (https://cdrns.nih.gov/) and making these data available for sharing, if requested, are expected to be described.

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.

PHS Inclusion Enrollment Report (Pilot Projects)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. Each pilot project should have a Planned Enrollment Report to be associated with the individual project that will be conducting the study.

When preparing your application in ASSIST, use Component Type Enrichment Program.

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

The purpose of the Enrichment Program is to support interdisciplinary and collaborative educational and experiential activities that complement and/or enhance the development and research skills of post-doctoral students and New and Early Stage Investigators. The Enrichment Program will support activities with a primary focus on providing research experiences to promote the development of future leaders in nursing science.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Personnel: This category should include salary support for key personnel, including the Enrichment Program Director and any other professional and administrative personnel. Salary support charged to the Center grant must be commensurate with the time spent on Enrichment Program activities and is subject to institutional and NIH salary policies.

Other Expenses: Include funds to support Enrichment Program activities such as workshops, research fora, symposia, Center retreats and seminar series. Funds for Enrichment Program-associated activities such as the printing and distribution/mailing of brochures, programs, and meeting materials, as well as posters and other advertisement materials, may be requested.

Consultants: Include costs associated with consultants (e.g., consultant fees/honoraria, per diem, and teleconferences) when their services are required by the Enrichment Program.

Travel: Travel funds to support visiting scientists under the auspices of the Enrichment Program may be requested.

Specific Aims: Describe the aims of the Enrichment Program.

The Enrichment Program will be responsible for continued and coordinated professional development and scientific enrichment to ensure Center members, pilot investigators, and staff aware of new scientific advances, use of new technologies, methodologies and other science-related skills. The P20 Center Enrichment Program, as part of the Administrative Core oversight, is responsible for planning and organizing the various seminars, guest speakers, visiting scientists, consultants, and workshops including notification of these meetings to all Center and pilot project investigators. Staff schedule the agenda of meetings between Center members and the visiting lecturers and coordinate travel plans and expense accounts of the speakers. The Program will expand the research environment and network of investigators focused on MCC research by bringing the scientific progress of pilot and other Center supported studies to the attention of other investigators with the potential to contribute to Center research initiatives. All Enrichment Program activities must be designed to: 1) advance nursing science in complex multiple chronic conditions in human adult populations; 2) support scientific exchange among investigators with research interests in these topic areas; and 3) facilitate interactions between Center scientists and investigators from other fields with relevant expertise. In all cases, the Enrichment Program will further the overall aims and objectives of the Center and its Cores.

Research Strategy: The NINR P20 Exploratory Centers Enrichment Program will be designed to: advance research in multiple complex chronic conditions, promote scientific exchange among investigators with research interests in this topic area, and enhance interactions between nurse scientists and scientists from other fields with relevant expertise.

The Enrichment Program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. Applicants should describe any educational opportunities afforded by the P20 Exploratory Center for Center participants, and document ways the Center may facilitate, enhance or foster the institutional educational environment (e.g., F31, F32, T32), and the contribution of other organizations such as private foundations and commercial companies.

Letters of Support: Letters of support should be obtained from any organizations and/or individuals provide support or resources to the Enrichment Program

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. Plans for submitting all CDE data in the NINR/NIH Data Repository (https://cdrns.nih.gov/) and making these data available for sharing, if requested, must be described.

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.

Core

When preparing your application in ASSIST, use Component Type Core. This component is optional.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachments: Optional Core Use by Center Members and Other Investigators: Please title this attachment "Optional Core Use" and organize alphabetically by Center investigator (last name). List all Center investigators who will use Optional Core Resources and list their affiliation and what resources will be used. Applicants are strongly encouraged to use a table format.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe the aims of the Optional Core.

Research Strategy: Describe the structure and services of the Optional Core. Include justification of the need for the Core. Describe how the services of the Core contribute to the aims of the Center and to the topic of the FOA.

Letters of Support: Letters of support should be obtained from those providing resources to the Optional Core and from investigators who are/will be using the Core services.

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. Plans for submitting all CDE data in the NINR/NIH Data Repository (https://cdrns.nih.gov/) and making these data available for sharing, if requested, are expected to be described.

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.

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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 be asked to evaluate the following individual sections; all of these components will be considered in assigning the overall impact score:

• Overall, including the focus, quality of research, qualifications of personnel, collaborations among members, relevance to the Center's stated research focus.
• Administrative Core, including committee structure, Center membership criteria, and lines of communication.
• Pilot Administrative Core, including the organization of the overall process of solicitation, review, and monitoring of pilot projects, the facilitation of inclusion and development of New Investigator/Early Stage Investigator and post-doctoral pilot project PIs.
• Pilot Projects, including the strength of the scientific premise, approach, the rigor of the design, inclusion of targeted Common Data Elements, and the appropriateness to the topic of the Center and this FOA.
• Enrichment Program, including the quality of proposed activities and likelihood for promoting new scientific collaborations and directions/approaches.
• Each Optional Core, including the potential of the Core to empower nursing science by promoting new directions and creating research opportunities that are not available through commercial or institutional resources and that address the topic of this FOA; the documented need for and use of the proposed services; number of users; qualifications of personnel; management, including prioritization and responsiveness to the needs of the users; quality control management; and any appropriate developmental work.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the P20 Center 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 P20 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the Center 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 Center 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 PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing nursing research? Do the investigators demonstrate significant experience with coordinating clinical research or clinical trials? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their Leadership approach and plans for conflict resolution and organizational structure appropriate for the Center?

For this announcement, note the following: Are there enough funded investigators with programs of research related to complex multiple chronic conditions in human adult populations to support the aims of the Center? Are there enough qualified potential pilot investigators to complete the required minimum of five pilot studies related to multiple complex chronic illness in human adult populations?

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?

For this announcement, note the following: Will the Center make a unique contribution or fill a significant gap in the area of complex multiple chronic conditions in human adult populations? Will Center resources provide a unique contribution to the research infrastructure at the applicant College/School of Nursing?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center 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? If the Center involves NIH-defined clinical trials, does the application include a plan to address the Data and Safety Monitoring Plan and other NIH-policies regarding clinical trials?

For this announcement, note the following: Does the Center demonstrate an inter-disciplinary biobehavioral approach appropriate for its goals? Is the coordination among the Administrative Core, the Pilot Administrative Core, the Pilot Projects, the Enrichment Program and other Optional Cores adequately explained? Is there synergistic potential among the Center’s research components? Is there justification for each component in terms of the overall goals of the Center? Will the plans, as proposed, bring investigators into the Center from within and outside the institution?

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?

For this announcement, note the following: Does the Center have the technologies and capacity to foster interdisciplinary, state-of-the-art, and innovative research as proposed in the application? Does the proposed Center have a sufficient base of NIH funded research directly relevant to the FOA topic? Does the Center take advantage of the capability of its research base to maximize scientific productivity, particularly through interdisciplinary coordination and collaboration?

Overall Impact - Administrative Core

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, significant influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed). The review of the Administrative Core includes reviewing the plans for the Enrichment Program.

Scored Review Criteria - Administrative Core

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

Significance

Does the proposed Administrative Core address the needs of the P20 Center that it will serve? Is the scope of activities proposed for the Administrative Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the P20 Center?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Administrative Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing nursing research? Do the investigators demonstrate significant experience with coordinating clinical research or clinical trials? If the Administrative Core has multiple Directors, do the investigators have complementary and integrated expertise and skills; are their leadership approach, plans for conflict resolution and organizational structure appropriate for the Administrative Core?

Innovation

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

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the Center that the Administrative Core will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Center, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the P20 Center is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Center? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of human subjects?

For this announcement: Does the plan for sustainability address publications, presentations, policy briefs, measurement methods, scientific methods, use of a business model, development of an effective budget model, cost sharing partnerships with other Centers, leveraging products and additional research grants? Is there a clear plan for annual evaluation of the Center's success? Expected sustainability outcomes from a Developmental/Exploratory P20 Center are likely to differ in quality and magnitude from those associated with a larger and more developed P30 Center. Is a plan for evaluation of the Enrichment Program described? Is the evaluation plan likely to ensure the advance of the Center research aims?

Environment

Will the institutional environment in which the Administrative Core will operate contribute to the probability of success in facilitating the P20 Center it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Administrative Core proposed? Will the Administrative Core benefit from the unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Overall Impact - Pilot Administrative Core

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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).

Scored Review Criteria - Pilot Administrative Core

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

Significance

Does the proposed Pilot Administrative Core address the needs of the P20 Center that it will serve? Is the scope of activities proposed for the Pilot Administrative Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the P20 Center?

Investigator(s)

Are the Pilot Administrative Core Director and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in advising and coordinating clinical research or clinical trials? If there are multiple Pilot Administrative Core Directors, do the investigators have complementary and integrated expertise and skills; are their Leadership approach, plans for conflict resolution and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of pilot (delayed onset) awards?

For this announcement: Are the qualifications, experience, commitment and competence of the Pilot Administrative Core Director appropriate? Is there an appropriate time and effort commitment made by the Pilot Administrative Core Director? Does the applicant have experience overseeing the selection and management of delayed onset awards? Does the Pilot Administrative Core Director have an ongoing record of accomplishments in advising nurse scientists?

Innovation

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

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the Center that the Pilot Administrative Core will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Center, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the P20 Center is new, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Pilot Program? Are an appropriate plan for work-flow and a well-established timeline proposed?

Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of human subjects? If the Center involves NIH-defined clinical trials, does the application include a plan to address the Data and Safety Monitoring Plan and other NIH-policies regarding clinical trials?

For this announcement: Are clear plans for the distribution of announcements of the availability of pilot project funding, review, selection and advising and oversight of new pilot (delayed onset) awards described? Are appropriate plans for oversight of the progress of pilot projects described? Is there a clear plan for evaluation of the success of the Pilot Administrative Core activities? Is there a clear plan for appropriate oversight and record keeping for all pilot projects with Human Subjects? Is there a clear plan for facilitating the inclusion and development of NI/ESI and/or post-doctorate pilot project PIs?

Has a clear plan for administration of the Common Data Elements information required for the pilots been delineated? Does the plan include use of NINR demographic CDEs and at least two of the three CDEs outlined in the FOA (PROMIS-Pain, PROMIS-Fatigue, Psychological Well-Being Scale, SF-36)? Is the planned use of CDEs appropriate to the Center topic and multiple complex chronic conditions in adult populations?

Does the application describe how day-to-day management of Pilot Administrative Core resources will be accomplished? Does the Pilot Administrative Core enhance and complement the Center’s scientific goals (i.e., is there a good fit of the Pilot Administrative Core to the Center)? Is there a plan for replacing and for terminating pilot studies when necessary?

Environment

Will the institutional environment in which the Pilot Administrative Core will operate contribute to the probability of success in facilitating the P20 Center it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Pilot Administrative Core proposed? Will the Pilot Administrative Core benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Overall Impact - Pilot Projects

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).

Scored Review Criteria - Pilot Projects

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

Significance

Does the pilot 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?

Investigator(s)

Are the Pilot investigator, collaborators, and other researchers well suited to the pilot project? If Post-Doctoral Fellows, Early Stage Investigators or in the early stages of independent careers, do they have appropriate experience and training? 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?

For this announcement: Does the designated Advisor have appropriate experience and training in the conduct of research and in advising nurse scientists? Is there a clear plan for how the Advisor will contribute substantially to the scientific and professional development of the candidate? Does the advising and oversight plan include a well-defined communication plan?

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project within the proposed timeline? 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 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 based on 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? If the Center involves NIH-defined clinical trials, does the application include a plan to address the Data and Safety Monitoring Plan and other NIH-policies regarding clinical trials?

For this announcement: Is the pilot project relevant to the topic of the FOA and to the aims of the P20 Center? Is the project feasible in the time allowed and with the proposed budget? Does the proposed pilot include the use of NINR demographic CDEs and at least two of the three CDEs outlined in the FOA (PROMIS-Pain, PROMIS-Fatigue, Psychological Well-Being Scale, SF-36)?

Environment

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

Overall Impact -Other Optional Cores

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).

Scored Review Criteria - Other Optional Cores

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

Significance

Does the Core address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the Core? 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?

For this application: Is there a clear justification of the Optional Core based on use by independently-funded Center investigators?

Investigator(s)

Are the Core Director(s) and other personnel well suited to their roles in the Core? Do the investigators demonstrate significant experience with coordinating clinical research? If the Center has multiple Directors, do the investigators have complementary and integrated expertise and skills; are their Leadership approach, plans for conflict resolution and organizational structure appropriate for the Center?

Innovation

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

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the Center that the Core will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Center, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the P20 Center is new, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Core? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of human subjects?

Environment

Will the institutional environment in which the Optional Core will operate contribute to the probability of success in serving the investigators for the P20 Center? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Optional Core proposed? Will the Optional Core benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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

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

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

When the proposed Center 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.

Not applicable

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable.

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan . Reviewers will comment on whether the application includes a Data Sharing Plan, including plans for submitting all CDE data in the NINR/NIH Data Repository (https://cdrns.nih.gov/) .

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Nursing Research 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 Advisory Council for Nursing Research. 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.

The Center must include the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and Guidelines, including those for research involving human subjects, and clinical trials, as applicable, including the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects. Center plans for review of clinical trials including development of data and safety monitoring plans for each pilot project that meets the NIH definition of a clinical trial (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html), assignment of data and safety monitoring boards, as applicable and assurance of NIH Policy of Good Clinical Practice training should be described (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).

All awardee-selected pilot projects require prior approval by NINR prior to initiation. Prior approval should be requested according to the NIH Policy) https://grants.nih.gov/grants/guide/notice- files/NOT-OD-15-129.html). NINR will review prospective pilot projects for fit with the NINR mission, human subject protection, inclusion plans and data and safety monitoring plans, as appropriate.

• The awardee institution will provide NINR with written study protocols and the plan for addressing risks and protections for human subjects in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution with provide NINR with specific plans for inclusion of women, children and minorities, including planned enrollment tables for each project.
• For pilot projects that are NIH-defined clinical trials, the awardee institution will provide NINR with:
• Specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies and NINR DSMP policies.
• Good Clinical Practice training should be documented (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).

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

Not Applicable

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 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 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: [email protected]

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

Lynn S. Adams, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-8911
Email: [email protected]

Weiqun Li, M.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5966
Email: [email protected]

Kelli A. Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
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.