Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The National Cancer Institute (NCI), through its Center for Global Health (CGH), seeks to promote cancer prevention and control (CPC) research in low- and middle-income countries (LMICs) through collaborations and research partnerships between the NCI-designated cancer centers and institutions in LMICs. This administrative supplement uses the World Bank's definition of LMIC. Through this funding opportunity announcement (FOA), the NCI will provide administrative supplement awards to currently-funded P30 NCI-designated cancer center grantees to support pilot research plans that focus on cancer prevention and control. The overarching purpose of these supplements is to stimulate and strengthen CPC research programs between researchers at the NCI-designated cancer centers and institutions in LMICs. It is anticipated that outcomes of this supplement will include collaborative research grants between investigators at the NCI-designated cancer centers and LMIC institutions. The applications should address questions that represent the needs of all stakeholders including the investigators, local Ministries or departments, and community members, so that the activity has a direct, local benefit. It is expected that the findings from these collaborations could improve cancer prevention and control strategies both in the US and abroad.

Cancer is a leading cause of death worldwide, with a disproportionate burden occurring in LMICs. It is estimated by 2025, the number of new cases globally will reach more than 19 million with the majority of this burden borne to residents of LMICs. A significant percentage of these deaths could be prevented if health systems in LMICs could respond more effectively. In high income countries (HICs), researchers and health systems have identified and implemented evidence-based cancer prevention and control strategies to mitigate risk factors at the population level. These include strategies such as vaccination, cancer screening, and life-style changes. Together, these strategies have contributed significantly to reducing cancer mortality in HICs.

In order to realize cancer control in LMICs, it is essential to identify, implement, and evaluate resource-appropriate and evidence-based strategies that are not only beneficial but also sustainable in public health settings. This initiative presents a unique opportunity to strategically develop new, or strengthen ongoing, partnerships between cancer prevention and control researchers at NCI-designated cancer centers and institutions in LMICs. These partnerships will develop and leverage the scientific and leadership expertise for global cancer control at NCI-designated cancer centers. Members of NCI-designated cancer centers have the breadth of expertise to respond to the research needs of the LMIC investigators and assist them in developing collaborative research plans.

Support through this administrative supplement is expected to enhance the cancer prevention and control research efforts in LMICs.

Research of particular interest includes projects focused on:

1) Clinical and translational research;

2) Detection and diagnosis of cancer, including anatomic and clinical pathology;

3) Health surveillance including cancer registries and death registries;

4) Knowledge sharing;

5) Implementation science;

6) Informatics and mHealth;

7) HIV-associated malignancies; or

8) Malignancies associated with chronic infection.

As appropriate, the pilot projects can augment existing programs; however, adequate justification is required.

This administrative supplement supports partnerships between one NCI-designated cancer center and one LMIC institution. Cancer centers applying for supplements are expected to leverage existing research capacity supported by NIH/NCI in the LMIC.

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.

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

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 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.

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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

Applicant organizations may submit one application, provided that it is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center

The Cancer Center Director must serve as the PD/PI of the supplement.

Applicants must prepare applications using current forms in accordance with the Application Guide.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide (PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.
Telephone: 240-276-5810
Fax: 240-276-5820
Email: [email protected]

All page limitations described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

The Research Strategy is limited to 3 pages.

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

Shannon L. Silkensen, PhD
Center for Global Health
National Cancer Institute (NCI)9609 Medical Center Drive, Room 3W566
Rockville, MD 20850
Telephone: 240-276-5810
Email: [email protected]

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

Introduction: describe how the proposed supplemental activities relate to the parent award.

Specific Aims: include a brief statement of expected impact and scientific relevance of the supplemental research program to global health, cancer prevention and control in LMICs. Specify the general scientific priority listed in the Funding Opportunity Description section of this FOA. Indicate whether this is an established or new collaboration.

Research Strategy: Describe the planned research and explain how it relates to the priority areas defined in this Administrative Supplements Program. Explain how the proposed supplemental activities will enhance research activities conducted under the parent award. Research should be culturally and resource appropriate.

Applications should address the following points:

1. Describe how the research program builds on the scientific strengths of the US and LMIC institutions.

2. Describe how, and at what frequency, the research study design and results will be shared with the LMIC community. Indicate how LMIC community feedback will be collected with regard to stakeholder satisfaction on the inception, process, and completion of the application. Include how the community feedback will be assessed and incorporated into the project.

3. Identify the elements of the proposed pilot project that are anticipated to be self-sustaining.

4. Describe the anticipated short-term and mid-term outcomes of the research program, e.g. collaborative grant, publication, etc., and projected impact of the program on the community/study population. Include a description of the plans for a baseline assessment, monitoring, collecting data, implementing the proposed project, and estimating its impact.

5. Explain how the application can be both reasonably and feasibly accomplished during the project period; and

6. Describe how the proposed research activities will inform local public policy and practice.

Timeline: Include a timeline showing the planned research milestones for the project period.

Letters of Support: As the attachments, include letters of support signed by the Dean and Hospital President and/ or other appropriate institutional officials documenting specifics of institutional commitment both for the long-term future of the Center and for this award period.

All instructions in the Application Guide must be followed, with the following additional instructions:

• Include the primary site where the proposed supplement activities will be performed.
• If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

Describe the research environment at both the US institution and the LMIC.

All instructions in the Application Guide must be followed, with the following additional instructions:

• List the PD/PI as the first person (regardless of their role on the supplement activities).
• List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.

For the purpose of this supplement, Key Personnel includes: the Cancer Center Director and the cancer center and LMIC co-leaders of this project. Member(s) of the Cancer Center may serve as project co-leaders. Additionally, an LMIC investigator must serve as a project co-leader.

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

Describe the roles, responsibilities, and division of labor among all US and LMIC project staff;

Allowable costs are limited to:

• Salary support for:
• Key Personnel
• Other personnel
• The Cancer Center Director is not required to provide effort to this supplement
• Limited travel (up to $10,000/ year) for the LMIC co-leader to present the research at conferences. In the budget justification, include the destination, dates or duration of stay for all anticipated travel. It is important that the application clearly explains how the travel is directly related to the intent of this award.
• Costs for procuring specialized materials/ resources/ reagents that cannot be accommodated by the Cancer Center shared resources.

All instructions in the Application Guide must be followed, with the following additional instructions:
IACUC Documentation and IRB Documentation: If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

Not Applicable

Not Applicable

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 as described above. 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.

For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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 using the instructions specified above.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

Important reminders:
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 (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

NIH staff 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.

NIH staff 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.

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required 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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

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

Shannon L. Silkensen, PhD
National Cancer Institute (NCI) Telephone: 240-276-5810
Email: [email protected]

Paul C. Pearlman, PhD
National Cancer Institute (NCI) Telephone: 240-276-5810
Email: [email protected]

Not Applicable

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

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

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