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

This FOA invites Planning Grants for Regional Infrastructure Centers for the coordination of research on non-communicable diseases, mental health and injuries, in low and middle-income countries. The purpose of this FOA is to facilitate the planning and designing of Regional Centers of Research Excellence (RCREs). These RCRE Planning Grants will build on collaborative partnerships among investigators from institutions in high-income countries (HICs)/ Upper Middle Income Countries (UMIC) and low- and middle-income countries (LMICs).

RCRE Planning Grants are encouraged to link with and capitalize on the region's existing and potential research capabilities and develop a plan to coordinate the basic, translational, clinical, and population science research for Non-Communicable Diseases (NCDs) in these regions. These capabilities include and are not limited to research programs, population cohorts, HIV-AIDS and other infectious disease programs, drug and vaccine delivery programs, screening programs, and tobacco control programs.

Proposed activities must focus on research infrastructure gaps and NCD-related problems that have been identified as high priority by investigators, ministries of health, science and technology organizations, and civil leaders in LMICs. The ultimate goal of this FOA is to provide support for the planning and design of a competitive application to support the full-development of sustainable RCREs that will: 1) strengthen scientific quality and volume; 2) boost collaboration; 3) fortify the scientific shared core facilities; 4) enhance research activities; and 5) provide the scientific evidence needed to inform public policy to create a sustainable model empowering LMIC institutions. At least one of the NCD-related problems identified for research support under this award must be cancer-focused. The plans produced during these P20 awards will provide a plan for a RCRE that may be supported by a future FOA.

Research plans can focus on NCDs in populations across the lifespan, from pregnancy/fetal development through childhood and adolescent to all stages of adulthood including aging adults. Additionally, NCD research can focus on primary prevention, secondary prevention, screening, diagnosis and/or treatment of NCDs.

The RCRE Planning Grants will create a network that will develop, share, evaluate, and disseminate best practices, guidelines, standard operating procedures, and data within the LMIC NCD research community.

Before the end of the grant period, successful applicants should demonstrate functional informatics systems. These may include and are not limited to virtual meeting software, data sharing software, and collaboration environments.

At the end of the planning grant, successful awardees will have produced a plan for a Regional Infrastructure Center. Specifically, this plan will have several sections, including:

• a completed local needs assessment that includes documented community engagement;
• a well-conceived research plan that specifies the short-, mid-, and long-term outcomes of the research program;
• the projected impact of the research on the region;
• a multidisciplinary research enhancement activity plan that will support the proposed research programs by providing appropriate enrichment options including but not limited to courses, laboratory experiences, enhanced mentoring, etc.;
• a well-justified plan for consolidating existing or opening new shared core facilities; and
• concrete metrics for monitoring and evaluating the quality, value, and scientific impact of the RCRE.

At the end of the grant period, the awardees also will have demonstrated an ability to undertake successful collaborative research by completing at least one small joint NCD-focused research project of relevance to the LMIC investigators. One challenge that RCRE planning grant applicants must address is how to create RCREs that support the NCD research needs of the present and which can be augmented to fulfill the regional NCD research needs of the future. These plans will be disseminated widely by the NCI in a special publication. Lastly, selected RCRE planning grant recipients will be visited to provide clarification and evidence of their RCRE plan.

NCDs include the four most prominent chronic diseases, namely cardiovascular diseases, cancers, chronic respiratory disease, and type-2 diabetes, as well as mental health disorders, allergy, asthma, and injuries. Together, these diseases account for more than 72% of premature deaths globally, http://www.who.int/about/structure/organigram/nmh/en/. LMICs carry a disproportionate burden of NCDs; both mortality rates and disability from NCDs are considerably higher in LMICs than in HICs.

The NCI has the responsibility to coordinate the research it supports. Heretofore, there has been sub-optimal coordination of efforts or sharing of resources and best practices for addressing NCDs at the country and/or regional level. In many instances, this has led to a duplication of efforts and a difficulty to build sustainable infrastructure and human capital for research. Furthermore, the uneven availability of research (laboratory, library resources, etc.) and administrative (institutional review boards, grants administration, etc.) infrastructure causes investigators to spend a disproportionate amount of their time preparing for rather than conducting their research. Additional challenges include limited in-country financial support for research and training, thereby producing inadequate career development opportunities. The weak healthcare systems limit the ability for clinical research to be integrated into standard of care. In addition, existing surveillance systems are inadequate to inform the management of NCDs. The absence of regular communication between members of the research community, clinicians, and advocates makes changes to public policy challenging. Sustainable NCD, mental health, and injury interventions will require that these issues be addressed directly. Developing a coordinated, research-driven approach will ensure that the emerging scientific and health needs of the region are met. The research accomplished here will directly benefit both local and US citizens.

By design, shared core facilities are more efficient and cost effective than individual investigators supporting single pieces of equipment in their separate laboratories. Shared core facilities take advantage of many economies of scale: namely reducing the number of service contracts and repair calls made to an Institution, decreasing duplicate equipment purchases, and reducing personnel costs for technical staff. Conversely, there are several barriers to consolidating shared core facilities. Practical concerns include distance between researchers as well as incompatible administrative, financial, and computer systems. Other barriers often exist. These include access to the equipment, priority use, and the quality of the measurement. The RCRE planning grant will include an overview of the shared core facility infrastructure and a plan that overcomes such barriers and serves the proposed research of the region.

Scope: Planned RCREs are expected to bring together research components from multiple disciplines. Specifically, the planned RCREs are meant to support planned research programs related to the region’s cancer burden and at least one other regionally relevant NCD. The NCD research programs planned here should lay the foundation for self-sustaining, internationally competitive research programs in LMICs. Among others, the NCI will support proposed research programs focused on the ethical, legal, and social implications in research; cancer prevention and control; diagnostic pathology; implementation science; health inequalities; molecular and cellular biology; health inequalities; health systems and health delivery; and detection, diagnosis, and treatment.

The RCRE Plan must address at least two regionally relevant NCD-related problems. At least one of the NCD problems must be cancer-focused. The RCRE Plan must propose at least three shared core facilities that support the planned research programs.

Requirements: In order to prevent undue redundancies and to share information and best practices, awardees will interact on a regular basis via periodic teleconference calls and face-to-face meetings at the end of year 1 to discuss developments, progress, and insights gained throughout the project period.

This planning grant uses the World Bank's definition of HIC and LMIC. The U.S. is an HIC.

This planning grant defines LMIC institution as any research entity within an LMIC. Example research entities include academic institutions, hospitals, clinics, and non-governmental organizations.

This Planning Grant defines "research enhancement activities" as enrichment activities in research techniques for students at both the MS and doctoral levels, and of post-doctoral researchers. I t also includes ancillary support personnel such as technical training of laboratory staff, study coordinators, and data managers. Research enhancement activities may serve both degree and non-degree seeking personnel.

Geographic Distribution: The NCI plans to support a balanced geographic-distribution of meritorious planning grants, including the WHO regions of Africa, the Americas, South-East Asia, Europe, Eastern Mediterranean, and the Western Pacific, http://www.who.int/about/regions/en/. Planning grant recipients will be expected to share documents on best practices and lessons-learned with the scientific community, including other NCD planning grant recipients, biannually.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

To determine country income categories, please view the following: http://data.worldbank.org/country. The subcategories of LMICs are: upper-middle-income (UMIC), lower-middle-income and low-income countries.

At least two institutions, one in the HIC or UMIC and one in a LMIC must be involved as partners in the grant application (i.e. scientists in UMIC institutions are eligible to partner directly with other LMIC institutions).

Exceptions: Taiwan and Hong Kong are classified by the World Bank income list as high-income countries. Therefore, institutions based there are considered HIC under this FOA.

Applications may be submitted by either the LMIC institution or the HIC/UMIC institution. Applications from LMIC institutions are strongly encouraged and not required.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

Multiple PD/PI:

This FOA uses the multiple PDs/PIs mechanism. Applicants are required to have at least one PD/PI from a HIC or UMIC and one PD/PI from a LMIC institution. These PDs/PIs form a partnership in the grant application..

NIH intramural scientists and other members of the US Federal Scientific Community:

NIH intramural scientists and other members of the Federal scientific community are encouraged to participate in the RCRE Planning Grants as consultants.

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).

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:

Shannon L. Silkensen, Ph.D.
National Cancer Institute (NCI)

Telephone: 240-276-5809
Fax: 240-276-5820
Email: shannon.silkensen@nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6 pages
Coordinating Unit	6 pages
Planning Unit	6 pages

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
• Coordinating Unit: required
• Planning Unit: required

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: The abstract should include the long-term goals and objectives of the RCRE plan and key elements of the research, research enhancement activities, shared core facilities, and coordination plans. Additionally, it should include the countries and names of all partner HIC/UMIC and LMIC institutions; the rationale and design of the proposed research programs, and a description of how the proposed research programs benefits the public health of the people in the catchment area.

Facilities & Other Resources: The application should describe level of institutional funding, space allocation, research co-funding, endowments, faculty positions, salary for staff, protected time for research, purchase of equipment, and designation of center program status in the institutional bylaws.

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.

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.

NIH intramural scientists and other members of the US Federal Scientific Community:

Budget requests from federal agencies, including the NIH intramural research program, may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).

In general, the requests will be limited to the costs required for carrying out the proposed work. These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, supplies, and travel.

Justification must be included for Federal employees who will be committed to the project although no funds are requested in the application. This will allow the Scientific Review Group to evaluate the suitability of proposed staff to conduct the work.

Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe scientific aims of the planned RCRE and outline how the research, research enhancement activities, shared core facilities, and coordination cores will contribute to these aims.

Research Strategy: All applications submitted for this FOA should discuss the following:

Relationship between the RCRE and existing research, research enhancement activities, and shared core facilities: Applicants should clearly describe how the planned RCRE will complement government and other-supported programs within the LMIC region. Applications should describe the proposed value added; how duplication will be minimized; and how the proposed activities will lead to a sustained opportunity within the region. Competitive applications should include those HIC/UMIC and LMIC institutions working in the relevant region. Non-U.S. HIC institutions may be included in the HIC/UMIC-LMIC partnership. Applications that document partnerships among a HIC/UMIC, an established LMIC institution, and a neighboring, developing LMIC institution are encouraged.

Lastly, RCRE planning grant applicants must address how the planned RCREs will support the NCD research needs of the present and can be augmented to fulfill the regional NCD research needs of the future.

Description of the Center: Investigators can propose different frameworks for the development of the RCRE. It is expected that some components of the planned RCRE will be co-localized at a single LMIC institution, while other components may be pooled among other LMIC institutions. However, all planning grants must present a partnership plan that clearly delineates roles and responsibilities and division of labor between all HIC/UMIC and LMIC program staff and each partner institution. Investigators from the planned RCREs are encouraged to collaborate with appropriate LMIC ministerial entities, non-governmental organizations, policy-makers, health systems, and hospitals. The safety, security, and stability of the region’s environment, and how it will contribute to the success of the planned RCRE, should be assessed.

RCRE Leadership: The lead HIC/UMIC institution must document experience conducting research and research enhancement activities with at least one LMIC institution partner. Applications will include a comprehensive plan for a long-term engagement in the region, as well as criteria for the inclusion of additional institutions to the planned RCRE. Lines of authority should be clearly delineated, such that LMIC investigators will lead the research and research enhancement efforts and HIC/UMIC investigators will serve as collaborators, consultants, and mentors, emphasizing the importance of co-ownership in global collaborative efforts.

Timeline and Milestones: Create a 2-year, detailed timeline showing the planned coordination, research, research enhancement activities, and shared core facilities milestone activities for the RCRE Planning Grant.

Letters of Support: Applicants must provide letters of support signed by the Dean and Hospital President and/ or other appropriate institutional officials, relevant LMIC ministerial entities, non-governmental organizations, policy-makers, health systems, and/ or hospitals clearly and specifically documenting their commitments to research funding, space allocation, faculty positions, salary for staff, protected time for research, purchase of equipment, etc. for both the long-term future of the planned RCRE and for this award period.

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 Coordinating Unit.

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 Coordinating Unit
• 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 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 planned RCRE central Coordinating Unit budget may support the administrative functions of the Planning Grant.

Fund allocation should align with the effort needed to accomplish the goals of the component. It is expected that at least 60% of the direct costs awarded will be used at the LMIC site(s). Any remaining funds will be spent at the HIC/UMIC site.

Travel funds are limited to up to 20% of the total LMIC budget and 20% of the HIC/UMIC budget. For example, in Year 1, if in an HIC/UMIC and LMIC institution partnership, $120K direct costs are awarded to the LMIC institution and $80K direct costs are awarded to the HIC/UMIC institution. The LMIC institution could request up to $24K for travel and the HIC/UMIC institution could request up to $16K.

Up to 5% of both the total LMIC and total HIC/UMIC direct costs budget may be used to support travel to a RCRE PD/PI Steering Committee Meeting. This meeting will take place at the end of Year 1. For example, in Year 1, if an HIC/UMIC and LMIC institutions partner, $120K is awarded to the LMIC institution and $80K is awarded to the HIC/UMIC institution. The LMIC institution could request up to $6K for travel and the HIC/UMIC institution could request up to $4K

Community Engagement funds are limited to up to 5% of the total direct cost LMIC budget; no HIC/UMIC funds can be used for Community Engagement. For example, in Year 1, if $120K is awarded to the LMIC institution, up to $6K could be requested to support Community Engagement activities.

Examples of non-allowable costs include non-research educational activities, public relations and fund-raising.

Up to 5% of the total LMIC budget may be used to support a potential, final visit at the planned RCRE. This potential visit will take place at the end of Year 2.

Prepare a description, a consolidated budget of person months and justifications for all personnel.

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the administrative aims of the Coordinating Unit and outline how its services will support the research, research enhancement activities, and shared core facilities activities of the Center.

Research Strategy: All applications submitted for this FOA should include the following:

Coordinating Unit: This should describe the organization and general operation of the Coordinating Unit. Applicants must address (at a minimum) such aspects as:

• Mode(s) of operation (direct physical interactions, remote communications, usage of virtual space, etc.),
• Measures to ensure transparent and efficient administrative practices that serve all institutions;
• General areas of activities to be coordinated, including planning for, and/or acquiring, and/or building as needed:
• Robust general data systems with facilitated collection, storage, and access of data across partnering institutions;
• Appropriate specialized data systems as needed (such as laboratory information management systems, biobanking information management system, etc.)
• Financial and grants management personnel/resources ;
• Regulatory capacity that might be needed for research to be conducted in future RCREs;

Applicants should include plans that detail their engagement with the group of awardees. This engagement includes discussing developments, progress, best practices, standard operating procedures, guidelines, accomplishments, setbacks, data, and insights gained from planning their RCREs. Participation on periodic teleconference calls and at face-to-face meetings is expected.

Needs Assessment and Community Engagement: It is the responsibility of the applicants to focus their research on the local research needs and the priorities of all relevant regional stakeholders, (e.g., researchers, ministries, community members, non-governmental organizations, etc.) and address the scientific NCD priorities of the region. RCRE Planning Grants are expected to assess and identify research activities, health services, and human resources available to support relevant scientific and public health policy development. The plan should describe the local health environment. Specifically, each application should clearly explain how existing investments, and other supported research activities in the region, could be leveraged and integrated into the planned RCRE. Moreover, the needs assessment should include the anticipated number and types of people to participate in these research enhancement activities. Lastly, It should indicate how community feedback will be collected, with regard to stakeholder satisfaction, and include how the feedback will be evaluated and incorporated into the project.

Evaluation: All RIC Planning Grants applications must include a description of metrics for monitoring and evaluating the quality, value, and scientific impact of the planned RCRE on LMICs in the region. Metrics to assess the change in research quality, quantity, and continuity must be included. The plan should identify the elements of the RCRE that are anticipated to be self-sustaining, and how the HIC/UMIC partner will contribute to the continued success of the research and research enhancement activities goals of the planned RCRE. In addition, the plan should include a description of how the proposed activities will inform local public health policy.

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.

When preparing your application in ASSIST, use Component Type Planning Unit.

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

SF424 (R&R) Cover (Planning Unit)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Planning Unit)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Planning Unit)

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) (Planning Unit)

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 (Planning Unit)

• 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 (Planning Unit)

The RCRE Planning Unit budget may support the scientific planning of the Center.

Fund allocation should align with the effort needed to accomplish the goals of each component. It is expected that at least 60% of the direct costs awarded will be used at the LMIC site(s). Any remaining funds may be spent at the HIC/UMIC site.

Examples of non-allowable costs include non-research educational activities, public relations and fund-raising.

Prepare a description, a consolidated budget of person months and justifications for all personnel.

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.

PHS 398 Research Plan (Planning Unit)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe scientific aims of the Planning Unit and outline how the services it will provide with respect to the research, research enhancement activities, and the shared core facility activities of the Center.

Research Strategy:

Planning for Research activities:

• The RCRE Planning Grant application should describe a well-conceived plan that includes a scientifically compelling justification for the selected NCDs. Applicants should clearly and specifically describe the research environment in the LMIC and how it is well suited to support the proposed research programs. Furthermore, RCRE Planning Grants should explicitly state the anticipated short- and mid-term outcomes of the research programs and the projected impact of the programs on the community/study population and the relationship, if any, to the condition in other parts of the world. Lastly, RCRE Planning Grants should concretely explain how the proposed research programs may have an impact, or lay the groundwork, to reduce the burden of NCDs. For institutions with existing research programs, the applicant must explain what distinguishes the planned RCRE from other existing programs, how the planned RCRE will synergize with existing research programs, if applicable, and demonstrate that the pool of faculty, potential trainees, and resources are robust enough to support the planned RCRE.
• Additional activities could include health communications, health surveillance, biospecimen collection and processing, regulatory capacity, and clinical trials management. Applicants should consider including a basic science program at the beginning of their plan that will cultivate a culture of scientific research.

Planning for Research Enhancement Activities:

• RCRE Planning Grants are expected to identify all relevant activities that will fill gaps in NCD research capacity for LMICs in the region. The section should include a description of how the research enhancement activities will complement the research program plans and build on the scientific strengths of the HIC/UMIC and LMIC partner institutions. These activities may serve research and clinical fellows, students, and laboratory personnel. They should include any combination of course work, laboratory experience, and/ or mentoring. Additionally, they should include the types of planned research enhancement activities, and how comprehension will be assessed. The research enhancement activities can be in basic biomedical, clinical, or population sciences; behavioral or social sciences; prevention research; health services, operations and implementation research. Applicants are encouraged to design multidisciplinary research enhancement activities. The plan should also discuss long-term plans for ensuring human research talent remains in the LMIC regions.

Planning for Research Shared Core Facilities:

• The RCRE Planning Grant should describe the organization of the network of partners that address the NCD research needs identified in the needs assessment. The plan should include financial models to support shared core facilities, as well as expected usage and contributions from research grants, institutions, regional funding sources, etc. Applicants should specifically describe how the proposed shared core facilities will take advantage of the many economies of scale: namely reducing the number of service contracts and repair calls made to an Institution, decreasing duplicate equipment purchases, and reducing personnel costs for technical staff. Applicants are encouraged to develop creative collaborations to improve utilization of existing resources. In addition, plans for scientific prioritization of studies using the RCRE should be captured, describing the number and type of shared core facilities needed to support the NCD research in the region, as well as their present and anticipated capacity.
• Applicants must propose at least three shared core facilities that support the planned research programs.
• In addition to research area, applicants should also describe plans to develop Core Support Functions in the LMIC. These include research ethics committees, administrative oversight, and biostatistics, data management, and informatics support.

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.

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 (Planning Unit)

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 (Planning Unit)

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

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

See Part 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.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

The overarching goal of this FOA is to facilitate the planning and designing of Regional Centers of Research Excellence (RCREs) in low and middle-income countries (LMICs) to support research and research enhancement activities in the area of non-communicable diseases (NCDs), including cancer.

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

Does the planning grant address an important problem or a critical barrier to progress in the field? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA: How does the proposed RCRE framework serve the research needs of the region?

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

Specific for this FOA: How will the roles, responsibilities, and division of labor among all project staff and each partner institution meet the stated goals of the RCRE planning grant?

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

Specific for this FOA: Does the planning involve innovative ideas of developing a RCRE that is unique in its mission, approach, and delivery? Does the proposed RCRE sufficiently meet the challenges and gaps posed by the LMIC environment? How well has the applicant developed creative collaborations to improve utilization of existing resources?

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

Specific for this FOA: How reasonable and feasible are the proposed planning activities?

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

Specific for this FOA: How will the institutional support contribute to the success of the RCRE planning grant?

How well does the proposed plan integrate with other Research Programs in the region? How well does the plan further the region's organizing framework? How well does the plan take advantage of the region's infrastructure to allow for alternative approaches or perspectives to be quickly employed?

Review criteria for the Coordinating Unit are listed below. The Coordinating Unit will receive merit descriptors rather than numeric scores; individual criterion scores are not provided.

How will the responsibilities of the CU contribute to the success of the research, research enhancement activities, and shared core facility activities included in the planning grant? How will the planned needs assessment assess and identify research activities, health services, and human resources that could be leveraged and integrated into the RCRE? How comprehensive are the community engagement plans? How suitable are the metrics to assess the change in research quality, quantity, and continuity?

Review criteria for the Planning Unit are listed below. The Planning Unit will receive merit descriptors rather than numeric scores; individual criterion scores are not provided.

How convincing is the evidence that the research may have an impact, or lay the groundwork, on reducing the region's burden of NCDs? How does the research enhancement activity plan complement the research plan and build on the scientific strengths of the partner institutions? How does the shared resources plan complement the research plan and build on the existing scientific infrastructure and strengths of the partner institutions

As applicable for the Planning grant 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 planning grant 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.

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

Not Applicable

Not Applicable

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

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

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NCI in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Geographic distribution will also be considered in funding decisions
• 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

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

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

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

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
Email: support@grants.gov

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

Shannon L. Silkensen, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5810
Email: shannon.silkensen@nih.gov

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

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

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