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; 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.

Required Application Instructions

It is critical that applicants follow the 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 self-management of symptoms and build research teams for the future. The purpose of NINR P20 Centers is to plan and build new research teams in interdisciplinary, biobehavioral research for scientists conducting self-management of symptoms. In addition these P20 Centers seek to plan and build new research infrastructures and centralized resources in support of self-management of symptoms research. It is our goal to have NINR P20 Centers that will be successful in their efforts to: (1) build new and a potential sustainable interdisciplinary, biobehavioral research capacity for scientists conducting nursing research by establishing centralized research resources and a research infrastructure with the goal of sustainability and/or to secure further funding through other specialized or comprehensive grants; (2) build the Center’s thematic science area through complementary, synergistic research activities; and (3) begin to grow feasibility research that will develop into new research teams of the future and new independent investigators.

The areas of science to be considered include, but are not limited to, research that:

(1) enhances research infrastructure by expanding and targeting research resources available to promote and support Self-Management of Symptoms

(2) expands the number and quality of research projects aimed at improving (a) self-management of symptoms in persons of all ages with chronic and acute disorders, or multiple chronic conditions, (b) the self-management in persons with function-impairing symptoms and their caregivers, or (c) expands the number and quality of research projects aimed at improving health and quality of life in both healthy and chronically ill persons;

(3) expands the number of research investigators involved in interdisciplinary nursing science research;

(4) increases the quantity and quality of research projects utilizing genetics/genomics, and biobehavioral methods;

(5) plans for and develops sustainability of research programs by building an active and growing research program with collaborations and partnerships both inside and outside of the applicant organization.

Chronic diseases impair the quality of life (QOL) of more than 90 million Americans. Self-management has become an essential component of disease management and a major goal for the 15%-20% of children and 80% of older adults who have one or more chronic conditions.

Promoting self-management is essential across the lifespan. Much of the self-management research to date has focused on older populations. With the graying of America, the caregiving burden and costs of chronic illness and disability in older adults have led to catastrophic health care projections. Greater self-management of middle aged adults with chronic conditions may lessen this burden and lead to the enhancement of QOL and reduced disability as these adults age. Likewise, older adults may acquire greater self-management skills, thus reducing or slowing their decline and lessening the significant economic, financial, and QOL burdens on those left to care for them.

In young people, chronic illness can be difficult, typically requiring the engagement of both child and their parent(s) and sibling(s). Research elucidating the best timing and means to transition children from partial to full responsibility for self-management is critically needed. The economic and QOL costs of chronic illness, disability, developmental delay, and behavior problems in children and adolescents are devastating to families and are predicted both to grow and be enduring. Research to improve family functioning and QOL in the context of interventions designed to improve self-management in children are key aims in the NINR Strategic Plan (http://www.ninr.nih.gov/aboutninr/ninr-mission-and-strategic-plan).

Even though the specific concerns in chronic illnesses may vary greatly by disease and developmental stage, children, adults, and families dealing with any chronic illness have much in common. Learning to live with a chronic condition poses a significant challenge at any age. Recruiting the cooperation and assistance of family members, friends, and health care providers can add to this challenge. Successful self-management cannot be attained without attention to the psychosocial environment of the person living with chronic illness. Poor family relationships and low levels of family support are associated with poorer adherence with treatment regimens, while high levels of family functioning and family support are associated with better treatment adherence. Although engagement in self-management does not assure good adherence (which is known to reflect many different variables), poor understanding and poor commitment to treatment regimens are known barriers to adherence.

Self-management has been defined as the ability of the individual, in conjunction with family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences associated with a chronic illness or condition. Self-management is intended to improve well-being and strengthen self-determination and participation in health care, while reducing inappropriate health care utilization and health care costs. Research on the effects of self-management, both on the individual with a chronic disorder, on those around them, and on society at large must be developed in order to plan for the health and wellbeing of the nation. Research to predict who will benefit from self-management interventions is essential. Biobehavioral measures and new research and intervention methods are needed to maximize the benefits of self-management relative to the costs, both economic and psychosocial, of illness.

Chronic diseases and their symptoms account for 70% of all deaths in the U.S., which is 1.7 million each year. These diseases also cause major limitations in daily living for almost 1 out of 10 Americans or about 25 million people. Symptom management for those with chronic conditions is an urgent public health concern. Each year chronic pain alone affects over 116 million Americans and accounts for $650 billion in health care costs and lost productivity (IOM report, June 2011). Fifty to 70 million Americans chronically suffer from sleep difficulties, hindering daily functioning and adversely affecting health and longevity (Report Brief: Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem, 2006, April National Academy of Sciences). Depressive symptomatology and depression significantly affect approximately 7 - 25 percent of the US population and are associated with increased medical illness, higher rates of comorbid conditions such as obesity and cardiovascular disease, and increased mortality.

Symptoms are the result of a complex interaction of biological, cognitive, behavioral, sociocultural, spiritual, and environmental factors. The responses to symptom treatment and management are equally complex. Managing recurring or chronic symptoms is often challenging as symptoms rarely remain static. Some patients may experience isolated symptoms (e.g., headache pain); however, many conditions result in characteristic symptom clusters (e.g., pain, sleep difficulties, and mood changes). Self-management of symptoms research seeks to identify and test self-management interventions that will reduce the burden of symptoms on affected persons and improve their quality of life.

This call for Center research applications that will build teams for the future focuses on the self-management of the most frequently reported symptoms:

1. pain,

2. sleep disturbances,

3. fatigue, and

4. cognitive/affect changes, as well as their interactions.

Applicants must select one or more of these symptoms and build their Center application around the self-management of the symptom(s), the organizing central theme of the application, so as to develop strong expertise in this research domain and move the field of science forward significantly.

NINR Centers

NINR currently supports a number of Exploratory/Developmental Center (P20s) and Centers of Excellence (P30s) grants. The purpose of an NINR P20 is to: (1) develop new and a potential sustainable interdisciplinary, biobehavioral research capacity for scientists conducting nursing research by establishing centralized research resources and a research infrastructure; (2) build the Center’s thematic science area through complementary, synergistic research activities; and (3) begin to grow feasibility research that will develop into new research teams of the future and independent investigator research applications.

If an applicant has considerable/substantial resources and research expertise in the field of self-management of symptoms then the applicant should consider applying for the NINR P30 FOA.

It is expected that new biomedical and behavioral knowledge will be discovered for improving self-management of symptoms of persons with acute and chronic disorders, and for improving the quality-of-life of all patients and their caregivers, across the NINR research mission areas and strategies presented in the 2011 NINR Mission and Strategic Plan (http://www.ninr.nih.gov/aboutninr/ninr-mission-and-strategic-plan ).

Interdisciplinary, biobehavioral, and programmatic approaches to improve the self-management of symptoms are needed. Attention to health disparities in the self-management of symptoms is encouraged. Leveraging resources through collaborative efforts from existing entities such as CTSAs, Practice Based Research Networks or other NINR funded Centers is encouraged. Applicant organizations should submit nursing research applications in areas specific to the self-management of symptoms in the NINR strategic plan priority areas. Applicants are to select a topical area for their application based on a conceptually sound integration of the currently funded projects that comprise the research base of the Center. Applications should propose innovative ideas consistent with NINR's mission. Although not inclusive of all topics that would be considered responsive to this FOA, applicants are encouraged to review the NINR s Strategic.

Self-Management of Symptoms Areas of Opportunity: Examples of areas of science that would be considered are listed below but are not limited to:

• Developing technologies to facilitate early self-identification and self-reporting of symptoms.
• Designing culturally appropriate self-management of symptoms and decision-making strategies or programs that promote healthy lifestyle choices such as diet, exercise, and primary health care practices in acutely or chronically ill persons.
• Defining the biobehavioral factors that support adherence to treatment for complex acute and chronic illnesses and develop interventions or programs that promote effective treatment and self-management of symptoms
• Designing evidence-based interventions and/or programs that promote independence and self-management of symptoms in long-term care settings.
• Identifying cost-effective strategies for self-management of symptoms and promotion of personal health among long-term survivors of disease and persons with chronic disabilities, including routine health monitoring and attention to co-morbid conditions.
• Improving knowledge of biological and genomic mechanisms associated with symptoms and symptom clusters in the context of self-management
• Designing interventions to improve the assessment and self-management of symptoms over disease trajectories, including the transition from acute to chronic illness
• Studying the multiple factors that influence behavioral self-management of symptoms and applications for the design of personalized interventions
• Developing strategies to improve self-management of symptoms related to chronic illness across the lifespan, particularly in the context of symptom comorbidities
• Developing strategies to assist individuals and their caregivers in managing symptoms associated with chronic illness, including analyses of caregiver burden and cost-effectiveness

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

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

Other

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

The applicant organization must be a School of Nursing.

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.

The PD/PI must be a nurse scientist and hold a doctorate degree. The PD/PI must also be a faculty member or senior investigator of equivalent rank at the applicant School of Nursing.

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

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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 P30 or P20 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 8 years and they have a research focus on self-management of symptoms research.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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 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:

Dr. Yujing Liu, Chief, Scientific Review Branch
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 451-5152
Fax: 301-480-8260
Email: [email protected]

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

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
• Pilot Projects Core: required
• Cores (Other): optional

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.

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 to Center members priority access to Institution’s and Center s facilities and services at minimal or reduced cost.

Equipment: A general listing of major, shared pieces of equipment to be used by Center members should be provided and the process including fee structure (if any) to access shared equipment.

Other Attachments: The following attachment should be included with the Overall Component in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. The attachment must be in pdf format.

Center Collaborations: Title this attachment Center Collaborations and organize alphabetically by Center Member (last name, first name). List all Center Members. Provide primary Department Affiliation, including location of research space, key words for research interests, and names of any Center members

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 PD/PI (overall Center Director) must be a doctorally prepared nurse scientist currently employed at a school of nursing.

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 specific aims of the Center, overall.

Research Strategy: The application must:

• Describe the strategy by which the goals of the Center will be met
• Provide a plan for ensuring the solvency of the proposed team once an award has been made and for resolving conflicts between the Center Director and other Center members.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When 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.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

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 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 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 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 Director 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 (15% time and effort) to the Core’s activities.

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.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Describe the specific aims of the Administrative Core.

Research Strategy: The Administrative Core 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 of the Core
• A description of the strategy by which the Administrative Core will enhance and expand the self-management research community;
• 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 human subject or vertebrate animal research is in compliance with appropriate regulations and guidelines governing animal use and studies involving human subjects research.

The Administrative Core is responsible:

• To review utilization of funds, including funds for research Projects and other Core(s) activities, and assure the appropriate expenditure of these funds
• To optimize the utilization of the shared resources of the Center, such as all Core(s) resource.
• For the development and execution of an evaluation plan and a plan for sustainability.

It is expected that the Center’s Administrative structure will accomplish the following:

• Coordinate and oversee the administrative functions of the Center;
• Review utilization of funds, including funds for research Projects and other Core(s) activities, and assure the appropriate expenditure of these funds;
• Plan for the sustainability of the Center after the period of support is completed, including development of collaboration(s) and preparation for seeking NIH R01 support.
• Oversee an Executive Committee, consisting of the heads of all Cores and appropriate business official(s), which should be established to assist the Center Director in the allocation of Center resources, the identification and selection of key personnel, and the planning and execution of
• Center activities. Other members can be added to the Executive Committee at the Director’s discretion.
• Oversee an External Advisory Committee (EAC) of scientists and administrators which should be established and composed of at least 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. Each meeting will have an appointed Chair. The meeting of the EAC minutes as well as a response from the Center Director on meeting EAC recommendations must be included in the yearly progress report.

The Center Director and other Center components, as the Director deems appropriate, are responsible for the evaluation plan:

• The need for collecting appropriate data (such as publications, presentations, grant awards, and other accomplishments that accrue as a result of the Center activity and presence) is emphasized. This will allow for annual planned evaluation of goals attainment and subsequent medial action as needed. As a result 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 are required. This plan should include the specific criteria and methods that will be used for the evaluation. The plan should specify the types of evaluation information that will be submitted in the Center's annual progress report.

The Evaluation Plan should include:

• The specific criteria and methods that will be used for the evaluation.
• The types of evaluation information that will be submitted in the Center's annual progress report.
• Measurable goals for each project year relating to progress of each Core and research Project, collaborative research activities, dissemination and impact of knowledge gained from research projects, and efforts to facilitate sustainability.
• The plan for evaluating progress, which must include maintaining a detailed record of the research projects, oral and poster presentations and publications derived from Center activity and funding, grant submission activity resulting from Center activities, 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 annual assessment of goals achievement.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

Pilot Projects Core

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.

SF424 (R&R) Cover (Pilot Projects Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Pilot Projects Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Projects Core)

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

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

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.

Project /Performance Site Location(s) (Pilot Projects Core)

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.

Research & Related Senior/Key Person Profile (Pilot Projects Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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 Project Core Director must hold a doctorate from a research training program (e.g., PhD) and be a faculty member or senior investigator of equivalent rank at the applicant institution.
• An eligible Pilot Project Investigator must be a Nurse Scientists from the applicant's School of Nursing. This includes the following:
• A nurse scientist investigator from the applicant School of Nursing who has not been a PD(s)/PI(s) of a self-management of symptoms study in the past, or who is not currently funded by a DHHS research Project grant (i.e., R01, R03, R15 or R21). Investigators currently funded with other mechanisms, such as R34, R41, R42, R43, R44 or any K awardee, are eligible for pilot project support.
• An established nurse scientist investigator (i.e. one currently funded by a DHHS research Project grant (i.e., R01, R03, R15 or R21) who wishes to develop skill and expertise in conducting self-management of symptoms and for whom this area represents a clear and distinct departure from his/her ongoing research interests. Strong justification must be made in the application to include an established investigator as a Pilot Project Investigator. Evidence that this project represents a new research career path that will be sustained by the Pilot Project Investigator is required.

The Center Director (PD/PI) and any of the Core Directors may not serve as a Pilot Project Investigator.

Budget (Pilot Projects Core)

Pilot Projects cannot be used to supplement already-funded research at the applicant organization.

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.

PHS 398 Research Plan (Pilot Projects Core)

Specific Aims: Describe the specific aims of the Pilot Project Core

Research Strategy: Applications must propose a minimum of two Pilot Projects to be started during the first year.

These two Pilot Projects must be undertaken and completed during the first two years of Center grant support. Pilot projects should not be used to fund phase 3 clinical trials. New projects must be developed in subsequent years (with a minimum of 1-2 projects ongoing each year).

Each Pilot Project must follow these guidelines:

• The theoretical or conceptual basis for the pilot and/or feasibility studies must be clearly explicated.
• An interdisciplinary approach is required to promote the collaboration of nurse scientists with scientists of other disciplines as appropriate.
• The application must indicate how the proposed pilot/feasibility study fits within the scientific area of nursing inquiry selected for the Center, and must tell how the investigator satisfies the eligibility criteria
• A timeline for the initial 2 pilot projects must be submitted.

The Research Strategy for this core should include a description of the process to select and review Pilot Projects. The Center review process may be carried out by the Advisory Committee, by an ad hoc Review Committee, by a mail review, or by a combination of these methods. It is recommended that the Center Director use at least two scientists with expertise relevant to the scientific area of inquiry of the Center from outside the institution during the review process.

Human Subjects and/or Vertebrate Animals: 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, including the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects. Human Subject and Animal Subject approval dates for Pilot and Feasibility projects should NOT be submitted with the application, but should be provided to NINR for approval with Just in Time information, or prior to the start of the pilot project, and with annual progress reports. Otherwise indicate in the appropriate section that human subjects or vertebrate animals are not involved.

Common Data Elements: NINR encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.

For the purposes of this FOA for P20 Centers, the following common data elements for symptom science must be used across center pilot studies in the self-management of symptoms in the following symptoms areas:

Topic	CDE
Pain	PROMIS-pain
Fatigue	PROMIS-fatigue
Sleep	PROMIS +additional duration question
Affective-mood	PROMIS Positive Affect PROMIS Depression
Affective-anxiety	PROMIS Anxiety
Affective-well being	Psychological well-being scale SF-36
Cognitive	PROMIS applied cognition & general concerns
Demographics	Ethnicity Race Educational level Date of birth Gender

This list does not preclude the use of other elements that would be necessary for the outcomes of the proposed studies.

In addition all CDE data will be stored in a future NIH data repository and should be made available for sharing, if requested.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Pilot Projects Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Projects Core)

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

Cores - Other

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

Optional cores, including but not limited to a Design/Methodology/Statistics Core, or a Biobehavioral Tools Core, may be added to facilitate the achievement of goals and objectives. An important consideration is the degree to which core facilities (a) will be utilized by and benefit ongoing and/or proposed Projects and Center investigators and (b) will assist in the development of the activities related to self-management research.

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

SF424 (R&R) Cover (Cores - Other)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Cores - Other)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Cores - Other)

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

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

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.

Project /Performance Site Location(s) (Cores - Other)

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.

Research & Related Senior/Key Person Profile (Cores - Other)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core 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.

A Core Director must hold a doctorate from a research training program (e.g., PhD) and be a faculty member or senior investigator of equivalent rank at the applicant institution

Budget (Cores - Other)

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

These items also need to be followed.

1. A Core Director must contribute no less than 1.8 person months (15% time and effort) to the Core’s activities.

2. Core budgets may not be used to supplement any research project within or outside of the Center. Cores are not intended to function as independent research projects, however, they may investigate the benefit of the Core’s services/resources, or means of enhancing Core services/resource provision.

3. No one core should constitute greater than one third of the dollars allocated for Core projects.

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.

PHS 398 Research Plan (Cores - Other)

Specific Aims: Describe the specific aims of the Core.

Research Strategy: The Research Strategy must include the following:

• Description of the Core service or resource, and evidence of need for Core
• Evidence of and plans for interaction with all Center Projects and other Center Cores
• Plan for and mechanism to announce availability of Core resources to the University, or research community (i.e., beyond Center investigators)
• A mechanism to track the nature of each service exchange. (Note: Needing to also track the amount/duration of each service exchange is listed in the Budget Section above.)

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Cores - Other)

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

PHS 398 Cumulative Inclusion Enrollment Report (Cores - Other)

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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.

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.

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 components of participating organizations, 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 NOT-OD-13-030.

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

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

Does the Center Director or Core Director have the ability to provide scientific and administrative leadership and direction?

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?

Will the Center make a unique contribution or fill a significant gap in the area of self-management research? Will the Center resources provide a unique contribution to the research infrastructure at the applicant organization?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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?

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?

Does the Center demonstrate a multi- and inter-disciplinary biobehavioral approach appropriate for its goals? Is the coordination among the Administrative Core, the optional Cores, and the Pilot Projects adequately explained? Is there synergistic potential among the Center’s research components? Is the evaluation plan likely to ensure the advance of the Center research aims? Is there justification for each research and Core 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?

Does the Center have the technologies and capacity to foster interdisciplinary, state-of-the-art, and innovative research? Does the proposed Center have a sufficient base of NIH funded research directly relevant to Self-Management research? Does the Center take advantage of the capability of its research base to maximize scientific productivity, particularly through interdisciplinary coordination and collaboration?

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 Admin Core address an important problem or a critical barrier to progress in the field? 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 qualifications, experience, commitment and administrative competence of the Administrative Core Director appropriate? Is an appropriate time and effort commitment made by the Administrative Core Director? Is there evidence that the Administrative Core, other Cores, and research Projects staff have worked closely together in the preparation of the application and will continue to do so in meeting the proposed Center objectives?

Has an investigator been named to head the evaluation effort? Does this individual have the qualifications, experience, commitment and competence to accomplish the task? Is there evidence that the researchers and faculty of the Center have worked closely together in the preparation of the evaluation and sustainability plan and will continue to do so in annually evaluating progress?

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

Is the organizational structure adequately developed, well-reasoned and appropriate to the aims of the Center? Does the application describe how day-to-day management of the Center will be accomplished? Are the plans to facilitate and monitor attainment of Center objectives appropriate? Are contractual and consortium arrangements adequately described, if applicable? Are plans for Center scientific growth and development over the Project period appropriate and adequately described? Are plans for sustainability and long-term management of the Center appropriate?

Is the evaluation plan adequately developed, well-reasoned and appropriate to the aims of the Center? Does the application describe how monitoring, tracking, and corrective adjustments in activity will be determined or take place? Does this tracking accommodate the information required for annual progress reports to NINR?

Does the evaluation plan include well-defined and quantifiable outcome measures? Are the overall plans to facilitate and monitor attainment of Center objectives appropriate? Does the evaluation include an accounting of resources and resource utilization, as well as efforts taken to maximize the research utilization of these resources? Does the evaluation plan include plans for sustainability of the Center?

Environment

Is institutional commitment to the pursuit of Self-Management research and other proposed activities, including provision of resources, administrative authority and recognition, convincing? Is there evidence of institutional commitment to incorporate and highlight the Center and its activities at the institution level and beyond?

Review Criteria Pilot Projects 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 Pilot Projects Core address an important problem or a critical barrier to progress in the field? 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?

Investigators

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

Are the qualifications, experience, commitment and competence of the Core Director appropriate? Is there an appropriate time and effort commitment made by the Core Director? Is there evidence that the researchers and faculty of the Core and the Projects and Administrative Core have worked closely together in the preparation of the application relative to the Core resources and will continue to do so in meeting the proposed Center objectives?

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 Pilot Projects Core? 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?

Is the organizational structure adequately developed, well reasoned and appropriate to the aims of the Core? Does the application describe how day-to-day management of Core resources will be accomplished? Are there plans to identify emerging Core resource needs of the Center and applicant organization? Are Core plans appropriate to facilitate and monitor attainment of Center objectives?

Does the Core enhance and complement the Center s scientific goals (i.e., is there a good fit of the Core to the Center)?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

Is institutional commitment to the Core in its pursuit of resources to support Self-Management research, including provision of resources and recognition, convincing?

Review Criteria - 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? 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 qualifications, experience, commitment and competence of the Core Director appropriate? Is there an appropriate time and effort commitment made by the Core Director? Is there evidence that the researchers and faculty of the Core and the Projects and Administrative Core have worked closely together in the preparation of the application relative to the Core resources and will continue to do so in meeting the proposed Center objectives?

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

Is the organizational structure adequately developed, well reasoned and appropriate to the aims of the Core? Does the application describe how day-to-day management of Core resources will be accomplished? Are there plans to identify emerging Core resource needs of the Center and applicant organization? Are Core plans appropriate to facilitate and monitor attainment of Center objectives?

Does the Core enhance and complement the Center s scientific goals (i.e., is there a good fit of the Core to the Center)?

Environment

Is institutional commitment to the Core in its pursuit of resources to support Self-Management research, including provision of resources and recognition, convincing?

As applicable for the Center 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

Not Applicable

Not Applicable

As applicable for the Center 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 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 (NACNR).. 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.

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.

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address 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 will provide NIH 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.

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.

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

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

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Donna Jo McCloskey, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-594-5971
Email: [email protected]

Yujing Liu, MD, PhD
National Institute of Nursing Research (NINR)
Telephone: 301451-5152
Email: [email protected]

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
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.