It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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 purpose of this funding opportunity announcement (FOA) is to support inter-disciplinary research on HIV-associated malignancies in low-and middle-income countries (LMICs) through the formation of multilateral partnerships between institutions from LMICs and the United States (U.S.). These partnerships are referred to as HIV-Associated Malignancy Research Center (HAMRCs).

These U54 HAMRCs will conduct research projects in countries with a significant burden of HIV-associated cancers (e.g., Kaposi sarcoma, cervical cancer, ocular surface squamous neoplasia, lymphoma, and hepatocellular carcinoma). The proposed research projects should focus on increasing our knowledge on risks, pathobiology and treatment of HIV-associated cancers. These projects are expected to be relevant to specific needs of a given LMIC region and support the development of strategies for prevention, care and/or management of HIV-associated cancers.

This initiative will also foster the development of junior investigators from the U.S. and LMICs interested in conducting research on HIV-associated cancers.

This FOA will allow mechanistic clinical studies that meet NIH's definition of a clinical trial (NIH's Definition of a Clinical Trial). These studies must be designed to understand a biological or behavioral process, the pathophysiology of disease, and/or the mechanism of action of an intervention (examples of mechanistic clinical trials can be found in NOT-OD-18-010). Clinical trials seeking to establish safety, assess clinical efficacy or effectiveness, and/or study/manage/implement, preventive, therapeutic, or services interventions will not be allowed or supported.

The proposed research projects must also address one of the HIV/AIDS research priorities listed on the Office of AIDS Research website (NIH's HIV/AIDS Research Priorities). Specifically, priorities four and five: HIV-Associated Comorbidities, Coinfections, and Complications and Cross-Cutting Areas.

Each application in response to this FOA must be based on collaborations between researchers working at U.S. institution(s) and researchers working at LMIC institutions.

Investigators and institutions involved in the prior U.S.-LMIC partnerships on HIV-associated malignancies are encouraged to consider this FOA. However, such prior involvement is not required and the FOA is open to all qualified applicants, who can meet the specific requirements detailed below.

Key Terms for This FOA

• Low-and middle-income countries (LMICs). LMICs are countries of per capita income as defined using the World Bank classification system (according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income (http://data.worldbank.org/about/country-classifications/country-and-lending-groups ).
• HIV-Associated Malignancy Research Center (HAMRC). A HIV-Associated Malignancy Research Center in this FOA refers to a multilateral partnership that involves at least one U.S. institution and institutions from at least two LMICs. Each proposed HMARC must be focused on one specific scientific theme relevant to HIV/AIDS-associated malignancies and the needs of the LMICs involved. Together, HAMRCs will form a network of U54 research centers dedicated to research on HIV-associated malignancies.
• Scientific Theme. A scientific theme for a given U54 HAMRC is defined as an area of study that is relevant to HIV-associated cancers and central to all research activities of that HAMRC. Accordingly, each research project proposed must focus on specific research questions within the scientific theme that a given U54 HAMRC has chosen to address. Scientific themes may be defined for various types of HIV-associated cancers including (but not limited to): hematologic malignancies, virally-associated cancers, pediatric cancers, and/or epithelial cancers.
• Clinical Trials: The NIH definition of a clinical trial applies to this FOA. A clinical trial is defined as 'research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. This FOA will only allow mechanistic clinical trials to be proposed. These are trials designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention but do not address safety and efficacy.
• Junior Investigator: A participating U.S. or LMIC investigator with doctoral level degree and subsequent advanced training (postdoctoral fellowship, residency, etc.), who may be at a junior faculty level (such as instructor, assistant professor, assistant member or equivalent) but is not a fully independent researcher (with ranks below associate professor or equivalent).

HIV-positive patients in LMICs are living longer due to the wide availability of combination antiretroviral therapy (cART); as these countries implement treatment guidelines, the number of people living with HIV will steadily increase. The spectrum of malignancies that is emerging in people living with HIV vary among the different regions of the world. It is projected that in LMICs the cancer burden and associated mortality will significantly increase as people living with HIV (PLWH) age. Cancer rates in LMICs are affected by the presence of oncogenic (particularly human papillomavirus [HPV], Epstein Barr virus [EBV], Kaposi sarcoma-associated herpesvirus [KSHV], hepatitis B virus [HBV] and hepatitis C virus [HCV]), younger age of acquisition of these oncogenic viruses, and behavioral risk factors. Also, these countries have health care systems that are poorly equipped to screen, diagnose, and treat cancer in the people of their populations.

In 2014 and 2017, the NCI, in collaboration with the Fogarty International Center (FIC), supported collaborative consortia to conduct research that addressed country-specific questions on HIV-associated cancers and the development of junior investigators in LMICs. The first FOA was the Sub-Saharan African Collaborative HIV and Cancer Consortia (U54) (RFA-CA-13-010). A similar initiative was subsequently developed that solicited applications for consortia between a U.S. and a LIMIC (excluding African countries funded through the first FOA). This second FOA was Collaborative Consortia for the Study of HIV-Associated Cancers: U.S. and Low-and Middle-Income Country Partnerships (U54) (RFA-CA-16-018). Collectively, these initiatives have increased research capacity at the partnering LMIC institutions and developed new scientific leaders in HIV and cancer.

The partnerships under the previous initiatives were limited to a single LMIC per award. However, the increased research capacities in LMICs that have been developed over the past five years it is now feasible to conduct research on HIV-associated cancers across multiple LMICs. This FOA addresses this opportunity by supporting partnerships that will involve multiple LMICs.

Overall Goal for the U54 HAMRCs

The primary goal for the U54 HAMRCs to be supported under this FOA is to conduct research on HIV-associated cancers that can more easily be done in LMICs that have the relatively greater burden of these diseases than the U.S.

The secondary goal is to provide research opportunities in the field of HIV-associated cancers that would foster the development of junior investigators (from both LMICs and the U.S.) in this field.

Like the predecessor initiatives, this FOA provides the ability to continue supporting junior investigators in LMICs. In addition, the new U54 HAMRCs are intended to expand such efforts to also include junior investigators in the U.S. interested in conducting HIV-associated malignancy research in LMICs.

Main Characteristics of the U54 HAMRCs

Each proposed U54 HAMRC must have the following characteristics:

• Partnership involving at least one U.S. institution and institutions from at least two LMICs with meaningful contributions of each partner to the HAMRC goals.
• Each U54 HAMRC should reflect an equal and shared partnership between U.S. and LMIC investigators.
• A defined, comprehensive research program focused on one theme relevant to HIV-associated malignancies (e.g. hematologic malignancies, virally-associated cancers, pediatric cancers, epithelial cancers).
• This research program must consist of two to three research projects, each focusing on relevant, complementary, and synergistic areas of research in the proposed theme that together will have an impact in the partnering LMICs and the research community.

Areas of studies may include but are not be limited to the following examples:

• Research that addresses gaps in knowledge in the pathogenesis of cancers that are relatively rare in the U.S. but frequent in people living with HIV in an LMIC (e.g., Kaposi sarcoma, cervical cancer, ocular surface squamous neoplasia and hepatocellular carcinoma).
• Research to better understand the pathogenesis of HIV-associated cancers in PLWH and differences between analogous cancers in people without HIV.
• Research that provides new insights into the role of social determinants in cancer risk, cancer care, and adherence to care and how it impacts survivorship in the era of cART.
• Research that seeks to identify novel interactions of HIV with other co-factors (biological, environmental or exogenous) that modulate risk to cancer.
• Research focused on development of novel, low cost and technologically feasible approaches for the prevention, diagnosis, and treatment of HIV- cancers particularly those that can be implemented in LMICs.
• Research that evaluates optimal approaches that will guide strategies to improve the integration of cancer care with HIV care in the public health settings of LMICs.

Optional Clinical Trials. Albeit not required, applicants may propose studies that meet the NIH definition of clinical trials. However, if such studies are proposed, they must be mechanistic (e.g., designed to understand a biological or behavioral phenomenon, the pathophysiology of a disease, or the mechanism of action of an intervention) and NOT focused on the development of an intervention.

Required U54 HAMRC Organization

The proposed U54 HAMRC must include all the required components listed below.

• Research Projects (required). Two to three well defined research projects are required. Each project must address a question that advances scientific knowledge of the HAMRC's scientific theme. The proposed projects must be well developed, rigorous, and supported by a strong rationale that is based on integrating the available relevant information from various sources. (Supporting original research preliminary data are not required albeit encouraged, if possible.)
• Administrative Core (required) will be responsible for the overall administration, coordination, and management of the U54 HAMRC. The Administrative Core will also assemble an External Advisory Panel.
• Developmental Core (required) should focus on activities that will facilitate and enhance the professional development of early career investigators in the U.S. and LMICs.
• Shared Resources Cores (optional). The U54 HAMRC may include shared resource cores, if necessary, for the conduct of the proposed research projects. No more than three shared resources cores can be proposed, and any proposed core must support at least two research projects.

Non-responsive Applications

Applications with the following attributes will be deemed non-responsive and will not be reviewed:

• Applications proposing any clinical trials that include clinical development or testing of interventions for therapeutic or diagnostic or preventive purposes, or evaluation of intervention safety, efficacy, and clinical management.
• Applications proposing a self-standing institutional training/education/career development program (for example, activities towards a specific degree).
• Applications that propose projects that do not address one of the AIDS research priorities listed on the Office of AIDS Research website (OAR Research Priorities).

See Section VIII. Other Information for award authorities and regulations.

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

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• U.S. Territory or Possession

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Each application in response to this FOA must be based on a collaborative partnership (referred to as a U54 HAMRC) among researchers in U.S. institutions and researchers in institutions from at least two LMICs. Provided this condition is met, either a U.S. institution or an LMIC institution can apply to this FOA.

Additional Eligibility Requirements for Foreign Institutions

Only foreign institutions located in LMICs are eligible for support either as applicant institution or a partnering LMIC institution in an application from a U.S. institution.

LMICs are defined by the World Bank classification system (according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income (http://data.worldbank.org/about/country-classifications/country-and-lending-groups).

Non-U.S. High Income Country (HIC) institutions are not eligible to apply but may be named as additional partners and collaborating sites on applications submitted by any eligible institution (i.e., either LMIC or U.S. institution).

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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

Applicants are required to use the multiple PD/PI option so that there is shared leadership for the U54 HAMRC by the U.S. and LMIC investigators. There must be at least one PD/PI at the US institution and at least one PD/PI at the LMIC institution.

The primary appointment of the individual designated as contact PD/PI must be at the institution submitting the application.

All individuals designated as PDs/PIs must have expertise in HIV/AIDS, oncology or implementation research and the appropriate level of authority and seniority to direct the U54 HAMRC.

Individuals designated as the PDs/PIs are also expected to have a history of prior scientific and/or administrative collaborations relevant to the goals of this FOA.

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).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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.

Although a letter of intent is not required, is not binding, and does not impact 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
• Names, addresses, and telephone numbers of the PDs/PIs
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Geraldina Dominguez, PhD
National Cancer Institute (NCI)
Telephone: 240-781-3291
Fax: 240-541-4520
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Administrative Core	6 pages
Core (use for Developmental Core and Shared Resources Cores)	6 pages per Core
Project (use for Research Projects)	12 pages per project

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: Required
• Administrative Core: 1 Required
• Research Projects: minimum 2 required; maximum 3 allowed
• Shared Resources Cores: Optional, no more than three allowed
• Developmental Core: 1 Required

When preparing your application, 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. The title of the application should reflect the overarching topic of the application

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

Follow standard instructions.The following additional guidance applies.

Project Summary/Abstract: The Project Summary/Abstract should include the overall goals for the U54 HAMRC and the selected research theme must address a question on HIV-associated cancers. Also include a description how it addresses the NIH HIV/AIDS research priorities. The Project Narrative should summarize how the proposed research theme will impact the HIV-associated cancer burden in the LMICs. In addition, describe how the Developmental Core will support career enhancing activities for the junior investigators in the U.S. and LMICs.

Facilities and Resources: Include any information about available unique resources and/or special capabilities that may be relevant for collaborative studies. List all available resources pertinent to the research. Identify which partner is contributing which resources. Indicate which specific resources will be available to other partners in the U54 HAMRC (e.g. specific reagents, patient samples, and access to populations or data for epidemiologic studies). Include a summary of resources that will be available to support new scientific leaders in HIV-associated malignancies.

Other Attachments: Applicants must provide the following additional materials specified below in support of their application.

Each attachment must be uploaded as separate PDF files. The filename provided for each attachment will be the name used for the bookmark in the application image.

Attachment 1: Organizational Data. Provide the following information as a PDF file with the name Organizational Data :

Organizational chart of the proposed U54 HAMRC that includes the leadership for the management/administration of the U54 HAMRC, scientific leadership for the projects and cores and reporting structure of the External Advisory Panel.

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. Additional guidance:

Biosketches: In addition to standard items, provide documentation for any previous collaborations with other designated PDs/PIs, including, as appropriate joint projects/publications, joint grants, participation in previous NIH and non-NIH initiatives (e.g. HIV/AIDS Clinical Trials Networks, International epidemiology to Evaluate AIDS, AIDS Malignancy Consortium, Fogarty HIV Research Training Program for Low-and Middle-Income Country Institutions) etc.

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

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

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

Specific Aims:

Describe the overall goals of the proposed U54 HAMRC, including the integration of the overall theme with the research projects and cores.

Research Strategy:

Instead of standard Research Strategy sub-sections use the sub-sections A-C defined below.

Sub-section A: U54 HAMRC Overview and Significance.

In this sub-section address the following aspects.

• Describe the overall vision of the proposed U54 HAMRC and the significance of the chosen research theme to the partnering countries;
• Describe how the proposed U54 HAMRC will synergize the chosen theme across its multiple LMICs and institutions involved;
• Outline how the proposed research projects align with needs of the partnering countries and how they address the HIV/AIDS research priorities identified by NIH;
• Provide a narrative that describes the anticipated contributions of the proposed U54 HAMRC to the scientific knowledge about HIV-associated malignancies, especially how it will improve our understanding of prevention, diagnosis, and treatments of these malignancies in the LMICs participating in the proposed U54 HAMRC;
• Address specifically how the outcomes of the proposed research may reduce the burden of HIV-associated cancers in LMICs; and
• Address the vision of the proposed U54 HAMRC for enhancing professional development activities for U.S. and LMIC junior investigators.

Sub-Section B: Collaborative Experiences and U54 HAMRC Makeup.

In this sub-section the following items must be addressed.

• Collaborative Experiences (do not repeat information in biosketches)
• Describe the overall collaborative experiences of the participating HAMRC investigators in HIV/AIDS, cancer or other relevant areas. Specifically describe in detail how the PDs/PIs previously collaborated in those areas and their expertise in managing multi-project initiatives;
• Provide evidence that those collaborations have been productive and have substantially increased scientific knowledge and improved in-country research capacity; and
• Describe how the collaborations among the partners involved have benefited LMIC institutions.
• U54 HAMRC Makeup:
• Describe the structure of the proposed U54 HAMRC, the chain of command and the roles and responsibilities for the U54 HAMRC leaders;
• Provide specific evidence of equal and shared partnership this should include evidence of a balance distribution of leadership and responsibilities for research projects and cores; and
• Outline the overall leadership composition, plan/strategy, structure/organization for the U54 HAMRC and the roles and responsibilities of the U.S. and LMIC investigators in managing the U54 HAMRC and in accomplishing the proposed goals of the U54 HAMRC. Specifically include a description of the roles of each PD/PI in supporting the goals of the proposed U54 HAMRC.

Note: Project leaders and core directors can be either from the U.S. or LMIC institutions (if appropriate, some components may be jointly led).

Sub-Section C: Overall Strategy for Scientific Integration

In this sub-section the following elements must be addressed:

• Explain how the scientific aims and goals of the proposed U54 HAMRC will synergize across the different partners;
• Outline how the research projects and cores will integrate scientifically;
• Define the goals and strategies of the proposed U54 HAMRC for increasing research capacity in the partnering LMICs and in developing scientific leadership in the U.S. and LMICs; and
• Describe the anticipated interactions of the proposed U54 HAMRC with other relevant research programs/entities, explaining how such interactions may benefit the U54 HAMRC team in terms of training opportunities (e.g., FIC's HIV Research Training Program for Low-and Middle-Income Country Institutions) and Emerging Global Leader Award).

Letters of Support: Letters of support must be provided from the leadership of each of the participating institution to detail the institutional and personnel commitments to the proposed HAMRC. All letters of support for the entire application should be included here.

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.
• Resource Sharing Plan should be provided only under the Overall component, but it should cover all activities proposed for the entire U54 HAMRC

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, use Component Type Administrative Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question. (Answer NO)

Project Narrative: State the importance of the Administrative Core to accomplishing the proposed goals of the U54 HAMRC.

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 Administrative Core 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 contact PD/PI must be designated as Administrative Core lead and other PDs/PIs as co-leads.

Budget forms appropriate for the specific component will be included in the application package. Include budgets for the following items in the Administrative Core budget.

PDs/PIs Effort. All PDs/PIs (both from the U.S. and the LIMICs) will be expected to have a significant effort of commitment of at least 1.2 person-months. Salary support for faculty and research staff from LMIC institutions must follow salary guidelines of the institute and letters for such be provided by senior institutional officer.

Travel Expenses: Each application is required to budget funds for travel to the annual meeting of the HAMRC investigators (not to exceed six people). It is expected that all the PDs/PIs and research project leaders attend the meeting..

Other Travel Expenses budgeted may include, for example, PDs/PIs visits to the collaborating institutions, travel to scientific meetings (especially for junior investigators). All Travel Expenses (including travel to the annual meeting) for the proposed U54 HAMRC should not exceed $40,000 direct costs annually.

Enhancing Administrative Capabilities in LMIC Institutions: Budget allocation for enhancing administrative capabilities in partnering LMIC institutions should generally not exceed 5% of the direct costs for the entire Administrative Core; if a higher percentage is proposed, it should be strongly justified. Costs associated with research administration may include, but are not limited to, the following activities: hiring new sponsored program staff, hiring personnel to manage timely invoicing, purchasing new computers to ensure proper administrative and fiscal management to meet U.S. Federal requirements, and hiring staff that supports Institutional Review Board (IRB) and ethical requirements.

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

Specific Aims: Provide the strategies and goals for managing the proposed U54 HAMRC.

Research Strategy: The Administrative Core is expected to oversee the overall administration, coordination and management of the U54 HAMRC. Use sub-sections A-B defined below to describe the following elements:

Sub-Section A: Partnership Coordination Activities:

Describe how the Administrative Core will oversee the overall administration, coordination and management of the U54 HAMRC. Specifically, applicants must address the following aspects:

• Provide details on the responsibilities of the Administrative Core in supporting the PDs/PIs, project and Core leaders, and any personnel involved in managing the U54 HAMRC.
• Describe how the Administrative Core will support administrative activities (e.g. workshops, teleconferences, personnel matters) of the U54 HAMRC.
• The process that the U54 HAMRC will use to disseminate information to external entities (e.g., website, newsletter).
• The partnerships that the U54 HAMRC will develop with other existing programs (if applicable).
• The contributions of trainees from other NIH programs (e.g., FIC's HIV Research Training Program for Low-and Middle-Income Country Institutions and previously funded NCI initiatives) as well as non-NIH programs to the aims of the proposed U54 HAMRC.
• Where such expertise (e.g., grants administration, fiscal management, etc.) is not completely developed at a LMIC site, a description of the plans to help develop these capacities may be included. If appropriate, describe other ongoing efforts to enhance research administration at the institution and how the funds budgeted for the core may help fill previously identified gaps at the institutional level.
• Articulate the process for communicating with members of the U54 HAMRC, decision making, and conflict resolution. It should include contingency plans addressing solutions to setbacks and delays including those related to logistics, ethical approvals, travel/visa issues and other possible hurdles in developing the U54 HAMRC.

Sub-Section B: External Advisory Panel.

Address the following aspects:

• Explain how the proposed U54 HAMRC will convene and organize the required External Advisory Panel to advise the U54 HAMRC leadership.
• Outline your vision on how such a Panel may serve as a bridge between the specific research to be conducted at a given U54 HAMRC and the needs of the involved communities at large.
• Provide details on the anticipated composition the External Advisory Group and the rationale for considering specific types of experts and stakeholders (such as policy makers, health education specialists, institutional and government leaders, key opinion leaders and community advocates from the LMICs, etc.). When discussing the potential members of the group, do not mention any specific names; rather just indicate the desirable expertise/profiles.)
• Outline how the feedback from the External Advisory Panel will be sought and implemented by the U54 HAMRC.
• Specifically describe how the interaction between the U54 HAMRC and its External Advisory Group may help identify research directions and/or research outcomes that may better address community needs and/or inform health policy changes.

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.

Resource Sharing Plans should only be provided in the Overall component of the application.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Research Project.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (precede each title with "Project 1:", "Project 2:", or "Project 3:")
• 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: State the relevance of the project to improving the health of people living with HIV in LMICs and the U.S.

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

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

Budgets for individual research projects are not restricted but the combined budget for all projects must not exceed approximately two-thirds of direct costs for the entire application.

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

Specific Aims: Outline the specific aims of the proposed Research Project and explain how these aims contribute to the overall research theme of the U54 HAMRC.

Research Strategy: Use Sub-Sections A-D defined below to describe research project. Explain clearly in relevant sub-sections how each project conforms to the general requirements outlined in Section I, including the HIV/AIDS research priorities identified by NIH.

Sub-Section A: Significance.

• Describe the central problem/hypothesis to address and outline how the proposed research will contribute to meeting the goals and objectives of the U54 HAMRC and its scientific theme;
• Explain the advantages of conducting this research project largely within the LMICs involved and not in the U.S. or elsewhere;
• Indicate the project's relevance to the partnering LMICs and how it will leverage and strengthen existing research capacities at the LMIC institutions;

Sub-Section B: Innovation. Describe how the research project may provide a novel or innovative approach that could have the potential to reduce the burden of HIV-associated cancers in the partnering LMICs or improve the outcomes of patients with HIV-associated malignancies. Include any novel concepts, approaches, tools or technologies for the proposed studies.

Sub-Section C: Approach. This section should focus on the specific strategies that are being proposed. Explain the rationale for selecting the methods to accomplish the specific aims of the project. Describe the research design, conceptual procedures, and analyses to be used. Discuss associations with clinical project(s). Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project.

• Explain which partnering sites will be responsible for specific research activities of this project.
• For laboratory experiments and/or data analyses that are not feasible at a LMIC site, explain the reasons why the work needs to be done at a U.S. institution or elsewhere.
• If appropriate, provide the timeline for the transfer of the expertise/skills/technology from the U.S. institution or elsewhere to the requisite LMIC site.

Sub-Section D: Environment. Describe the relationships among the projects and the Shared Resource Cores (if proposed). Address any unique physical resources or availability of biological specimens or unique populations.

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:

Resource Sharing Plans should only be provided in the Overall component of the application.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Resource Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of the Core
• 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: State the relevance of the core to the success of the projects it will support.

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

Budget forms appropriate for the specific component will be included in the application package. Include budgets for the specified Shared Resource Core.

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

Specific Aims: Provide the specific aims for the core outlining which projects it will serve (must be a minimum of two projects).

Research Strategy: Describe the intended function and rationale for the proposed core. The description of the core must contain the following information:

• Explanation of which projects the Core will serve and how the proposed Core matches the research needs of the U54 HAMRC;
• Explanation of how Shared Resource Core might be dependent on or serve another Core (if applicable);
• The scope of expertise available, including the level of skills of technical personnel, if applicable, who will be responsible for the day-to-day operation (and who may not be included under Senior/Key Persons);
• The key characteristics of the proposed Shared Resource Core (including approaches to ensure rigor and proper quality control) and anticipated benefits for the projects to be served; and
• Explain how the core will differ and not duplicate any existing services at the partnering institutions.
• The justification for the location of the Shared Resources Core.

Note: The description must directly address the general requirement that any Shared Resources Core proposed must support at least two of the research projects and must not duplicate an existing resource.

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:

Resource Sharing Plans should only be provided in the Overall component of the application. T

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application, use Component Type Developmental Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of the Core (Developmental Core)
• 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: State the relevance of the Developmental Core to supporting junior investigators.

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

Budget forms appropriate for the specific component will be included in the application package. Include budgets for the specified Shared Resource Core.

Pilot Projects. The budget must include funds to support HAMRC pilot projects (up to $45,000 per year, direct costs). The requested amount should be commensurate with the number and scope of projects anticipated.

Other Professional Enhancement Activities. Up to $20,000 per year (direct costs) may be requested to cover expenses for other relevant activities to enhance professional development of U.S. and LMIC investigators.

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

Specific Aims: Provide the specific aims for the core that will facilitate and enhance the professional development of participating investigators (especially at the early stage levels) in the U.S. and LMIC countries.

Research Strategy: Describe the plans for the Developmental Core to facilitate and enhance the professional development of investigators in the U.S. and LMICs, with a focus on junior investigators.

Address both areas indicated below.

• Pilot research projects:
• Although no specific projects are to be included in the application, describe general types/attributes of anticipated projects, their expected number per year, anticipated duration of such projects (up to one year but can be shorter), etc.;
• Provide few examples of possible directions of research;
• Describe your expectations regarding the pilot projects enhancing the leadership skills of the junior investigators (with such aspects as assigning junior investigators to lead or co-lead pilot projects, providing them with appropriate mentoring by senior investigators as needed; facilitating access to additional training resources that might be required for them to assume leadership roles on pilot projects, etc.);
• Describe how pilot projects will be solicited, reviewed, and prioritized for activation; in these plans, explain:
• how the Developmental Core will ensure that all pilot projects fall within the overall theme of the U54 HAMRC (i.e., are connected to ongoing research projects);
• any special approaches that might be needed to provide optimized opportunities for junior investigators from both the U.S. or LMIC institutions;
• details on planned proposal solicitation frequency and format, review panel composition, basis for prioritization, etc.;
• logistics of the process in the context of multiple institutions and countries.
• Describe how the Developmental Core will monitor conduct of pilot projects to ensure compliance with all applicable regulations (e.g., annual IRB approvals, Federalwide Assurance (FWA), Institutional Animal Care and Use Committee (IACUC), human subjects research training, etc.) in domestic and foreign institutions.
• Other opportunities facilitating professional development: Outline plans for a range of other research-related activities and/or available opportunities that may enhance investigators' skills and advance their progression towards becoming independent investigators. Activities/opportunities to consider include (but are not limited to):
• exposure to various research-associated activities (periodic attendance to relevant scientific conferences and presenting own research results, participation in institutional/departmental workshops, seminars, journal clubs, etc.);
• facilitated access to skills enhancing courses, workshops (e.g., in scientific writing, grantsmanship, mentoring/leadership); and/or
• any applicable approaches for gradually increasing responsibilities of junior investigators involved (commensurate with the skills and level of a given individual).

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:

Resource Sharing Plans should only be provided in the Overall component of the application.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this FOA, note the following:

The emphasis of this FOA is on highly meritorious research efforts around HIV-associated malignancies conducted jointly by U.S. investigators and investigators in LMICs. These research efforts must be focused on the specific needs of LMICs but are expected to advance the general understanding of HIV-associated malignancies. To be viewed as highly meritorious, the proposed U54 HAMRC must also have a distinct emphasis on professional enhancement opportunities for participating investigators in the U.S and the partnering LMIC institutions, particularly those at the early stage levels.

Scoring. Reviewers will provide an overall impact score for the entire U54 HAMRC (Overall). In addition, assigned reviewers will provide individual "criterion scores" for the Overall application but not for the other components.

Other components of the U54 HAMRC [i.e., Administrative Core, each individual Research Project, Developmental Core, and optional Other Shared Resource Core(s)] will be evaluated but each will receive only one overall adjectival (not numerical) rating.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the U54 HAMRC 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 U54 HAMRC 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 U54 HAMRC that by its nature is not innovative may be essential to advance a field.

Does the U54 HAMRC address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the U54 HAMRC are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: How suitable are the U54 HAMRC's choices of research projects and plans for cores for the goal of advancing the LMIC institutions as independent research centers for HIV-related malignancies in the region? What is the likelihood that the U54 HAMRC's research will advance the field of HIV-associated malignancies? Will such advancements in the areas corresponding to the U54 HAMRC research theme have meaningful clinically-relevant implications (in terms of prevention and/or diagnosis and/or treatment of HIV-associated malignancies)? How significant will the proposed activities of the U54 HAMRC be on advancing research independence of LMIC institutions and their investigators? How does the proposed U54 HAMRC enhance the ability to be a resource in research and professional development of junior investigators in the U.S. and in LMICs? How does the U54 HAMRC synergize the goals of the U54 HAMRC across different LMICs?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the U54 HAMRC? If Early Stage Investigators or those 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 to this FOA: Are the expertise and backgrounds of investigators from the partnering institutions in the LMICs and the U.S. complementary and appropriately balanced for the goals of the U54 HAMRC and the goals of the entire initiative? Are the leadership responsibilities optimally divided between the LMICs and U.S. investigators? In the context of the documentation for prior collaborations across the PDs/PIs and other senior investigators, what is the likelihood that the HAMRC multi-institutional leadership will interact efficiently and productively?

In addition, for applications involving clinical trials

Regarding the proposed leadership for the project, do the PDs/PIs and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the U54 HAMRC? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the U54 HAMRC 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

U54 HAMRC Integration: How well do the proposed research projects fit into the overall goals and the scientific theme of the U54 HAMRC? Are the professional enhancement activities properly integrated with the proposed research? Are the contributions of all components to the U54 HAMRC clearly articulated and well-integrated?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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 to this FOA: Are the teams and resources available at the partnering institutions in LMICs and the U.S. complementary and appropriately balanced for the goals of the U54 HAMRC and the goals of the entire initiative? Are the responsibilities optimally divided across the LMICs and U.S. institutions to take advantage of respective environments in each participating institution?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Research Projects but will give only one adjectival rating for the entire project (criterion scoring is not used for this component). A project does not need to be strong in all categories to have major scientific impact. For example, a Research Project that by its nature is not innovative may be essential to advance the field.

Significance

Do the research projects address an important problem or a critical barrier to progress on HIV-associated malignancies in the LMICs? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive any changes in the partnering LMICs?

Investigator(s)

Are the Project Leads, collaborators, and other researchers well suited for the projects proposed? If Junior investigators or 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 fields? If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

What is the project potential to generate innovative ways to reduce the burden of HIV-associated cancers in the partnering LMICs or improve the outcomes of patients with HIV-associated malignancies? Is the project using any novel concepts, approaches, tools or technologies?.

Approach

Is the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the research project involves human subjects and/or NIH-defined clinical research or clinical trial, are there plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals based on sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? How well integrated or even synergistic is a research project with the overall scientific theme and the other components of the proposed U54 HAMRC?

Environment

Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Does the environment of other HAMRC components provide any unique advantages (such as physical resources or availability of biological specimens or unique populations, etc.).

Reviewers will provide only one overall adjectival impact rating for the Administrative Core (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:

• Is the proposed Administrative Core well matched to the needs of the U54 HAMRC? Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, regulatory and personnel management?
• Are the plans for establishing the External Advisory Panel appropriate? Is its role in the U54 HAMRC clearly defined?
• If appropriate, how well do the proposed activities for strengthening research administration address the needs of the LMIC institutions?

Reviewers will provide only one overall adjectival impact rating for each Shared Resource Core (criterion scoring is not used for this component). Reviewers will consider each of the aspects below in the determination of the merit of a Shared Resources Core.

• How well is the proposed Shared Resource Core matched to the needs of the research being proposed by the U54 HAMRC?
• How strong is the justification of the proposed Shared Resource Core in terms of providing essential services for two or more research projects?
• What is the overall quality of the proposed core services? Are adequate quality control processes proposed for the facilities or services provided by the Shared Resource Cores (including procedures, techniques, and quality control)?
• How strong are the qualifications, experience, and commitment of the Shared Resource Core Director(s) and other Core personnel adequate in the context of their ability to provide the proposed services?
• How does the core strengthen existing or add new capabilities at the LMIC partner institutions?
• Is the environment for the shared resource core adequate to support the program as proposed?

Reviewers will provide only one overall adjectival impact rating for the Developmental Core (criterion scoring is not used for this component). Reviewers will consider each of the review aspects below in the determination of the merit of the Developmental Core.

• What is the likelihood that the proposed professional enhancement activities will meaningfully aid U.S. and LMIC junior investigators on their way towards research leadership in working in low resource settings?
• To what degree will these activities facilitate building HIV-associated malignancy research capacity at LMIC institutions?
• Are the U.S. and LMIC institutional commitments to facilitate professional enhancements of U.S. and LMIC junior investigators appropriate and sufficient to advance their careers?
• How reasonable and realistic are the plans for pilot research studies to be led (or co-led) by U.S. or LMIC junior investigators?
• How well are other strategies and activities proposed to enhance research leadership capabilities of U.S. and LMIC junior investigators matched to the needs of these investigators?

As applicable for the U54 HAMRC 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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the 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 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 U54 HAMRC 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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not applicable

Not applicable

Not applicable

As applicable for the U54 HAMRC 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 involvement 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 .

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

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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 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. Selection may be influenced by other factors, such as geographical and topic balance as well as relevance to the NIH/AIDS research priorities.

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

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

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Defining the overall research objectives and approaches of the U54 HAMRC;
• Overseeing and coordinating the efforts of individual U54 HAMRC components and ensuring their optimal integration;
• Overseeing the conduct of the U54 HAMRC research projects and ensuring their scientific rigor;
• Ensuring compliance with the applicable mandatory regulations (including protection of human subjects);
• Overseeing establishment and maintenance of appropriate quality control procedures;
• Overseeing final data analysis and interpretation and preparation of publications;
• Participating as a voting member in the activities of the Consortia of U54 HAMRCs Steering Committee;
• Overseeing the Administration of the U54 HAMRC and logistical support for joint activities; and
• Overseeing the preparation of required reports and informing, as needed, the NIH Program staff members concerning U54 HAMRC progress in research projects and other activities.

All PDs/PIs will be expected to maintain significant effort commitment not smaller than that stated in the application (at least 1.2 person-months throughout the entire project period).

Participation in the Annual Meeting of HAMRC Investigators: Investigators from all the individual U54 HAMRCs should meet annually at one of the U54 HAMRC sites to present updates on progress, to exchange ideas, to develop interregional collaboration and to discuss problems encountered. It is required that at least PDs/PIs, and project leaders will attend these meetings. Meetings of the U54 HAMRC awardees supported under this FOA may be combined with analogous meetings for the awardees funded under RFA-CA-16-018.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

A designated NCI Program Director, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NCI Project Scientist will be the main NCI contact for all facets of the scientific interaction with the awardees and will provide advice to the awardee on specific scientific and/or analytic issues in addition to programmatic issues. As needed, additional NCI scientific staff members with relevant expertise may also become substantially involved in the HAMRC Network activities as Projects Scientists.

Additionally, an NCI Program staff member will be responsible for the normal scientific and programmatic stewardship of the award and will be named as Program Official in the award notice.

The main responsibilities of substantially involved NCI Program Staff members will include (but will not be limited to) the following aspects.

• Providing technical assistance, scientific input, and assistance in effort coordination across the network of the U54 HAMRCs;
• Promoting collaborations across the different U54 HAMRCs;
• Facilitating interactions of the U54 HAMRCs with other ongoing programs and studies supported throughout the NIH to avoid duplication of effort and encourage sharing and collaboration among the different programs;
• Recommending additional research endeavors within the constraints of the approved research and negotiated budget of the U54 HAMRC;
• Facilitating the HAMRC Annual Meeting; and
• Participating as a voting member of the HAMRC Steering Committee.

Areas of Joint Responsibility include:

HAMRC Steering Committee. The HAMRC Steering Committee will be the Network governing body.

The PIs/PDs of awards funded under RFA-CA-16-018 will participate in the new HAMRC Steering Committee.

The HAMRC Steering Committee will be composed of the following voting members:

• PDs/PIs and any designated senior investigator so that that each HAMRC is represented by a balanced representation of U.S. and LMICs investigators (each HAMRC will have one vote no matter the number of PDs/PIs; and
• The NCI Project Scientist(s) (who will collectively have one vote for the NCI).

In addition, Program Official and other NIH staff members may participate in the HAMRC Steering Committee meetings as non-voting members.

The HAMRC Steering Committee will meet three times a year; twice by teleconference and once at the annual Investigators Meeting. These meetings are expected to be joint meetings with those of the Steering Committee for Collaborative Consortia funded under RFA-CA-16-018 (during the period of overlap of both initiatives).

The responsibilities of the HAMRC Steering Committee will include:

• Guiding the overall scientific directions of the HAMRC Network;
• Promoting collaborations across the individual HAMRCs;
• Overseeing, evaluating, and prioritizing the HAMRC pilot projects; and
• Interacting with the Collaborative Consortia Steering Committee in the areas relevant to both initiatives.

Dispute Resolution:

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3291
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
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.