Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for Precancer Atlas (PCA) Research Centers, one of the three scientific components of the Human Tumor Atlas Network (HTAN) (NCI Human Tumor Atlas Network). HTAN is a collaborative research initiative for constructing 3-dimensional (3-D) and dynamic atlases of the cellular, morphological, molecular, and spatial features of human cancers and their surrounding microenvironments as they progress from precancerous lesions to advanced disease. Each PCA Research Center will construct one 3-D precancer atlas that comprehensively characterizes a pre-malignant lesion with an explicit focus on understanding the transition from a precancerous lesion to malignancy. The other two HTAN components are Human Tumor Atlas (HTA) Research Centers and a Data Coordinating Center (DCC). Each HTA Research Center will conduct research to develop one spatial tumor atlas at single-cell resolution driven by specific topics in cancer biology across the continuum from cancer initiation to metastasis. The DCC will serve the dual role of network and data coordination. It will also be responsible for meeting coordination. PCA Research Centers have three major areas of responsibility: (1) biospecimen acquisition, processing, and annotation, (2) molecular, cellular, and spatial characterization, and (3) data processing, analysis, modeling, and visualization. PCA Research Centers will collaborate with other PCA and HTA Research Centers and the DCC. Research Centers will work with the DCC to make the data and analytical tools available to the research community.

PCA Research Centers will construct atlases that utilize spatial and omics data in conjunction with multimodal patient data to characterize precancerous lesions as they progress to invasive cancer, regress, or obtain a state of equilibrium. A precancer atlas is a comprehensive, dynamic, high-resolution, multidimensional, multiparametric, temporal and scalable atlas of precancerous lesions and their surrounding microenvironment for select organ sites, including cancers that disproportionally affect minority, underserved, and high-risk populations. The data will be interrogated to characterized precancerous lesions and understand the subsequent events that drive the transition from a premalignant lesion to a malignant cancer as a function of time, find molecular markers of risk and early detection, identify targets to intercept and prevent development of invasive cancer and for predictive modeling to chart the potential trajectories of tumor development and progression.

The overall goal of the PCA Research Centers is to build atlases that:

1. Delineate biological, molecular, immunological, and pathological features of precancerous (precancer) lesions and their microenvironment. In case of familial and hereditary at-risk individuals, atlases should provide somatic and germline landscapes for precancer lesions and their evolution to cancer.
2. Lead to identification of neoantigens, neoepitopes, and actionable targets for interception in the context of cancer prevention.
3. Develop hypotheses that correlate the atlases features with biology such as precancer growth and aggressiveness and identify molecular drivers suitable for early intervention.
4. Develop hypotheses that correlate the atlases features with clinical endpoints to identify high-risk patients to inform clinical decision, identify low-risk patients to reduce un-necessary treatments, and develop better tools for improved screening for all individuals.

Definitions

Precancer: In absence of a consensus definition of precancer, a working definition has been generated for the purpose of this NOFO. Precancerous lesions are regions of histologically and/or molecularly abnormal tissues that more often progress to invasive carcinoma than healthy or normal tissue. Precancers can be defined as the following: lesions that may or are likely to progress to invasive cancer; lesions where there is clear evidence of an association with increased risk of invasive cancer; lesions which are different from normal cells and share molecular and phenotypic features with invasive cancer. Additional criteria to consider in precancer definition are: 1) somatic clonal evolution in normal tissue; 2) truly benign growths ( benign tumors ) that do not invade nearby tissue or spread, can share driver mutations, and press on vital structures; 3) limited to the epithelium without breaking any biological barriers (i.e., basement membrane); and 4) lesions identified in prophylactic resection specimens without evidence of invasive cancer. The definition of precancer also varies significantly by organs and cancer types.

Precancer Atlas: A precancer atlas is defined as a multidimensional cellular, morphological, and molecular map of a precancerous lesion. It is complemented with critical spatial information (at cellular and/or molecular level) obtained by utilizing a variety of methodological approaches including genomics, proteomics, imaging, modelling, and data visualization. The atlas should enable comprehensive visualization and understanding of the structure, composition, and multiscale interactions within the precancer and its ecosystem over time resulting in progression to invasive cancer, regression or obtain a state of equilibrium.

Background

NCI’s HTAN was launched as a community resource generating program in 2018 in response to Recommendation I (Generation of Human Tumor Atlases) of the Cancer Moonshot Initiative’s Blue-Ribbon Panel (BRP) Report and the authorization of the 21st Century Cures Act. The purpose of this recommendation was to create dynamic 3D maps of human tumor evolution to document the genetic lesions and cellular interactions of each tumor as it evolves from a precancerous lesion to advanced cancer . In alignment with this recommendation, the NCI called for a concerted effort among multidisciplinary research teams to generate molecularly defined, multidimensional spatial atlases of human tumors for a deeper understanding of the important transitions during tumorigenesis that span across precancer to invasive cancer transition, development of recurrence and/or metastasis, and response or resistance to treatment. The original Funding Opportunity Announcements were RFA-CA-17-034, U2C (HTAN-HTA), RFA-CA-17-035, U2C (HTAN-PCA) and RFA-CA-17-036, U24 (HTAN-DCC). The HTAN teams were directed to build atlases that could be employed to answer specific biological and/or clinical questions, such as how co-evolution of the tumor and tumor microenvironment direct precancer and invasive cancer development over time, impact response to therapy or promote or impede metastatic spread. Importantly, the atlases constructed by HTAN investigators have contributed to the fundamental understanding of precancer and cancer biology that have the potential to impact cancer diagnosis, as well as inform the development of interception and treatment strategies. The HTAN has generated valuable resources for the community that include data and metadata standards, experimental protocols, analytical methods underlying the HTAN atlases, and open access publications. HTAN resources can be accessed at https://data.humantumoratlas.org/. More information regarding available HTAN atlases, datasets, protocols, and analytical tools can be found at www.humantumoratlas.org.

To achieve these goals, the HTAN teams (HTA and PCA Research Centers) employed multimodal single-cell technologies, spatial genomics, proteomics, and multiplex tissue imaging in conjunction with clinical data to generate atlases across six tumor types (lung, breast, colon, pancreas, melanoma, and pediatric leukemia). The initial set of atlases leveraged advancements in single-cell and molecular imaging technologies to provide insights into the biology of precancers, invasive and metastatic cancers, and therapy resistance, and suggest opportunities for translation of a number HTAN findings.

Overarching Goals and Scope of HTAN

The overarching goal of the HTAN (HTA and PCA Research Centers) is to map tumor evolution using multimodal approaches, advanced multiplex technologies, and spatial image analysis (preferably 3D analysis) to capture the extensive interactions within precancerous lesions and tumors and the surrounding ecosystems as a function of space and time. These comprehensive atlases will allow the development of new classifiers for risk prediction, biomarkers for early detection, identification of potential targets for preventive interceptions, enhancement of diagnostic and treatment strategies for advanced cancers, and generation of hypotheses and insights to facilitate future research on underlying biological mechanisms.

Applicants must propose to build one atlas that aims to address a significant biological question in cancer research that is poised for translation to improve human outcomes. Applicants may focus on one cancer type that may span multiple transitions of the cancer continuum or focus on one site of common metastasis across tumor types.

The following elements are important aspects of all atlases to be constructed under the current set of NOFOs for PCA and HTA Research Centers.

• The tumor or tissue type is not prescribed, but atlases that add significant value to the current set of HTAN atlases (www.humantumoratlas.org) will be prioritized. Significant value may be added through multiple approaches, including but not limited to, proposing tumor or tissue types not included in the first phase of HTAN, proposing to include a unique sample set that diversifies or extends the impact of an atlas constructed in the first phase of HTAN, and/or adding longitudinal samples that increase the insight and impact of atlases constructed during the first phase of HTAN.
• Applicants must propose collecting at least two existing HTAN data types for which data and metadata standards and levels exist (at least one must be a spatial assay) to accelerate data sharing and integrative analysis (https://humantumoratlas.org/standards; https://humantumoratlas.org/explore ; https://humantumoratlas.org/data-access)
• Priority will be given to HTAN atlases that propose a diversity of patient populations consistent with the requirements of the NIH Inclusion Policies for Research Involving Human Subjects (as described in https://grants.nih.gov/policy/inclusion.htm). This may include patients with rare tumor types or subtypes. There must be an adequate representation of race and ethnicity so that future translational research based on the HTAN atlases are beneficial to a diverse population.
• Applicants must demonstrate in their preliminary data that the approaches proposed for atlas construction and refinement are reliable and reproducible and that the highest standards are exercised in biospecimen processing, experimental approaches, and data analysis.

HTA and PCA Research Centers will function in coordination with the HTAN-DCC and the NCI Cancer Research Data Commons to support the housing and widespread dissemination of data emerging from the HTAN atlases.

HTAN will support two types of atlas-building initiatives:

• PCA Research Centers (RFA-CA-23-040) will construct atlases characterizing precancerous lesions and their transitions to invasive cancers or regression or stabilization of the lesions. For cancer prevention, it is important to characterize at-risk tissues, including regions (tissue microenvironment) adjacent to the precancerous lesion. Where applicable, the interplay between somatic mutations and at-risk tissues and tissues' associated with inflammation and other chronic conditions should be taken into consideration. Tissues associated with germline mutations provide opportunities for the joint study of germline and somatic variants in relation to disease initiation and progression. Proposed atlases should discuss such complexities in the histologically normal tissues and illustrate the relationships with molecular, cellular and tumor microenvironment features to define the progression from precancer to cancer.

To the extent possible, precancer atlas construction supported by this NOFO should leverage tools, resources and infrastructure developed by HTAN and focus on streamlined technical approaches to achieve the clinically relevant goals at a faster pace. Because of the challenging nature of analyzing small premalignant lesions, the PCA Research Centers may focus on deriving insight from the most informative measures, which could be weighted towards bulk or single cell assays, and spatial assays. Precancer atlases must be constructed using an adequate and population-representative number of biospecimens. Priority will be given to cancer types that are easily accessible for longitudinal sample collection from the same patients and be associated with clinical outcomes.

• HTA Research Centers (RFA-CA-23-039 , U01 ) will construct atlases describing one or more transitions spanning the entire cancer continuum: precancer to locally invasive cancer to metastatic cancer, relapse/recurrence, dynamic response to therapy, and development of therapeutic resistance. The atlas efforts must leverage and expand upon the current HTAN resources and infrastructure and focus on creating spatial atlases at single-cell resolution that are driven by specific topics in cancer biology across the continuum from cancer initiation to metastasis, development of relapse/recurrence, and treatment response and/or resistance. HTA Research Centers will use dissociative single-cell/nuclei or bulk sequencing or other molecular assays in a supporting role to the proposed spatial analysis.

These atlas-building initiatives will be supported by the HTAN DCC (RFA-CA-23-041 , U24 ) which will be responsible for: (1) Data Standards, Storage, and Dissemination; (2) Consortium Coordination; and (3) Community Outreach

Specific Research Objectives and Scope of the PCA Research Centers

The objective of each PCA Research Center is to construct one multimodal, dynamic, and spatial atlas of a precancerous lesion by conducting comprehensive molecular, cellular, and tissue characterization of a human precancerous lesion and its microenvironment with spatial resolution. PCA Research Centers should focus on deriving insights from the most informative measures, that could be bulk or single cell molecular analysis. Applicants must propose to collect at least two existing HTAN data types (https://humantumoratlas.org/standards; https://humantumoratlas.org/data-access) for which data and metadata standards and levels exist (at least one must be a spatial assay) to accelerate data sharing and integrative analysis. When possible, the Centers must include longitudinally collected specimens from the same patients where outcome can be evaluated. These atlases should provide a deeper understanding of the transition of precancerous lesions to invasive cancer, generate testable hypotheses and have the potential to identify markers for early detection and risk assessment and molecular targets for preventive intervention.

Research conducted by PCA Research Center may include, but is not limited to:

• Determining the dynamics of somatic mutations; the interaction of germline mutations with somatic mutations, copy number alterations or other molecular changes that affect cellular fitness and immunity and contribute to initiation and progression of precancer lesions to frank malignancy, or regression.
• Leveraging recent developments in high-content molecular analyses (including single-cell and bulk analysis) to determine spatial and temporal dynamics (longitudinal measurements) of precancerous lesions and the surrounding microenvironment in detection of genomic drivers of progression or regression.
• Detecting spatial, functional and/or temporal features that are based on clinical context and allow for the development of methods (biomarkers) for cancer risk assessment or early detection and/or for the identification of targets for prevention of invasive cancers.

The rationale for selection of organ site should include following:

• Impact on Public Health: The proposed atlas should have the potential to have a substantial impact on clinical decision-making as well as its use by the scientific community. This is determined by public health burden, prevalence of the tumor, nature of the clinical question to be addressed, health disparities in racially and ethnically diverse populations, high risk populations and care settings.
• Access to Technologies and Biospecimens: The applicants must have access to state-of-the-art technologies and the resources to obtain well-characterized and well-annotated biospecimens (cross-sectional and longitudinal). Collected samples must be of high quality, quantity (for use in a variety of assays) and purity. While the final atlas-building effort should use uniformly collected and extensively annotated, longitudinal biospecimens, applicants are encouraged to apply HTAN developed and standardized technologies to interrogate retrospective samples (https:\\www.humantumoratlas.org).
• Feasibility of Atlas Construction: The feasibility of atlas construction is based on the available cohorts, number of available biospecimens, rate of progression to cancer and available tools and technologies.

Synergistic Partnerships for Maximizing Resources: The ability to partner with ongoing initiatives (federal, foundation, industry, etc.) is vital as this will increase access to cohorts, technologies, and other resources necessary for atlas construction. In this context, applicants are encouraged to collaborate with major programs under the Division of Cancer Prevention (https://prevention.cancer.gov/major-programs) including Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT), Cancer Preclinical Drug Development Program (PREVENT), Early Detection Research Network (EDRN), Translational and Basic Science Research in Early Lesions (TBEL) Program), Cancer Prevention Clinical Trials Network (CP-CTNet) and NCI Community Oncology Research Program (NCORP).

PCA Research Centers Organization

PCA Research Centers must be organized around three integrated functions: (1) Biospecimen acquisition, processing, and annotation, (2) Molecular, cellular, and spatial characterization, and (3) Data processing, analysis, modeling, and visualization. Applicants must address how they will fulfill these functions.

Biospecimen acquisition, processing, and annotation: The proposed atlas should be constructed with high-quality, well-annotated biospecimens that utilize prospective, longitudinal human samples when possible. Applicants should consider analysis of samples in partnership with ongoing clinical trials or well-established, cancer-specific tissue banks (i.e. Cooperative Human Tissue Network).

The type and frequency of biospecimen collection will depend on the precancerous lesion and the clinical context. Information pertaining to biospecimen collection, including but not limited to, clinical and epidemiological data and metadata, pathologic analysis, anatomic location (including information about landmarks that might aid in atlas construction), and pre-analytical processing must follow HTAN data standards (https://data.humantumoratlas.org/standards). Biospecimen and clinical data will be shared with members of the HTAN and the broader scientific community in accordance with appropriate NIH and HTAN data sharing policies. HTAN data and resource sharing policies can be found on the HTAN Data Portal under HTAN Policy Documents (https://data.humantumoratlas.org/resources). Applicants should read and share HTAN policy documents with collaborators to ensure that compliance is possible before submitting an application.

Molecular, cellular, and spatial characterization: The goal of a PCA Research Center is not to generate a data catalog, but to contribute to a framework for understanding tumorigenesis based upon the spatial architecture of the molecular and cellular components of the precancerous lesion. Applications that propose to primarily use dissociative techniques that do not preserve or otherwise inform spatial information or propose to primarily study non-cellular fluids will be of low priority or, if exclusively proposing these techniques without any attempt to reconstruct the multidimensional tumor ecosystem, will be considered non-responsive (see the Non-Responsive Applications section below for a comprehensive list of non-responsive criteria). Rather, it is envisioned that dissociative techniques might be utilized in support of in situ analysis techniques in an iterative fashion.

Applicants should leverage and expand upon existing knowledge within the field and are required to collect at least two existing HTAN data types, including one established spatial data type, for which data and metadata standards and levels exist to accelerate data sharing and integrative analysis. Characterization methods proposed must produce demonstrably high quality and robust data for integrative analysis. The proposed atlas workflow needs to be flexible in its design such that new technologies introduced through HTAN collaborative projects and/or related atlas-building projects might be quickly tested, validated, and adopted over the course of the award lifetime.

Data processing, analysis, modeling, and visualization: PCA investigators will pursue two important goals:

(1) Design and conduct at least one study illustrating how the collected data or data deposited in the HTAN DCC could be utilized to build a testable, predictive model of progression from a precancerous lesion to invasive cancer. The proposed use cases can utilize HTAN pilot funding to test atlas-derived hypotheses using human or non-human samples and/or experimental models (including data from the first phase of HTAN or from other atlas building efforts). The strongest use cases will generate biological insights poised for translation at the conclusion of HTAN funding.

(2) The Center’s informatics, computational biology, and data science experts will be expected to work in collaboration with other HTAN investigators, the HTAN DCC, and the NCI Cancer Research Data Commons to ensure consistency in data labeling, processing, and analytics across the HTAN program. The success of critical data-sharing efforts will require close coordination between the project personnel leading the biospecimen, characterization, and data analysis activities. Project personnel responsible for data analysis, integration, modeling and/or visualization will be expected to participate in HTAN scientific working groups focused on development and sharing of analysis and visualization tools, especially in regard to quality control, analysis, integration, and visualization of spatial data types. It is expected that representatives from all HTAN-funded projects will work in collaboration to ensure that HTAN data is usable by the biomedical research community. HTAN data and resource sharing policies can be found on the HTAN Data Portal under HTAN Policy Documents (https://humantumoratlas.org/resources). Applicants should read and share HTAN policy documents with collaborators to ensure that compliance is possible before submitting an application.

HTAN Organization, Governance, and Evaluation

Organization: HTAN will consist of HTA Research Centers (RFA-CA-23-039 , U01 , U01 ), PCA Research Centers (RFA-CA-23-040, U01), and a HTAN-DCC (RFA-CA-23-041 , U24 ), solicited under three separate NOFOs in Fiscal Year 2024. The HTAN will function as a collaborative Network allowing Research Centers to cross-test ideas, integrate diverse data sets, and validate (or refute) hypotheses derived from analysis of HTAN data. HTAN team leads and other members with relevant expertise will be expected to participate in HTAN working groups and work cohesively.

Applicants, regardless of which NOFO is of interest to them, are urged to read the companion HTAN NOFOs and to visit the HTAN Data Portal (www.data.humantumoratlas.org) to familiarize themselves with the Network and its research and/or data coordination requirements.

Governance: All components will be governed by the HTAN Steering Committee (see Section VI. Award Administration Information: Cooperative Agreement Terms and Conditions of Award) with representatives from the funded HTA and PCA Research Centers, the DCC, and the NCI Program Officials. The Steering Committee will provide input towards and oversight of HTAN collaborative activities, data sharing, data deposition to the HTAN-DCC, as well as overall integration of efforts among all HTAN awardees. The Co-Chairs of the Steering Committee will be PDs/PIs of HTAN cooperative agreement awards (U01 and U24) and will be elected by the Steering Committee after the launch of the second phase of HTAN.

Evaluation: The efficiency of funded research is an important priority for NCI. Therefore, the HTA and PCA Research Centers along with the HTAN-DCC will be expected to work with NCI Program Officials to collaboratively create project and program milestones prior to award. HTAN awardees are also expected to participate in an external evaluation process of the HTAN, which will be coordinated by the NCI Program Officials (see Section VI. Award Administration Information: Cooperative Agreement Terms and Conditions of Award). NCI Program Officials may also engage external program consultants who are not part of the HTAN program but with relevant scientific and consortium experience to provide input on the goals and direction of HTAN (see Section VI. Award Administration Information: Cooperative Agreement Terms and Conditions of Award).

Non-responsive Applications

The following types of applications are outside the scope of this NOFO; applications proposing them will be considered non-responsive and will not be reviewed.

• Applications primarily focused on the pursuit of a biological mechanism through basic research that does not result in an atlas.
• Applications focused on the progression of invasive cancer to metastasis are not responsive to this NOFO but may be responsive to RFA-CA-23-039 , U01 for HTA Research Centers.
• Applications proposing atlases constructed through exclusive use of non-human biospecimens.
• Applications based upon one experimental measurement and do not propose methods that provide multidimensional data/information regarding the spatial distribution of cellular and/or non-cellular components of the tumor.
• Applications that propose to primarily study biofluids for identification of biomarkers without any attempt to reconstruct the multidimensional tumor ecosystem.
• Applications that do not propose to collect at least two existing HTAN data types (at least one must be a spatial assay) for which data and metadata standards and levels exist,
• Applications that are not able to satisfy current HTAN policies,
• Applications that do not include biospecimens representative of patient diversity in the United States, as required by NIH policy.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

It is expected that applications will include multiple PDs/PIs to accomplish the goals of this NOFO. An investigator designated as a Contact PD/PI of an HTAN Research Project application must not be the designated Contact PD/PI of another application under this NOFO or under the companion NOFOs (RFA-CA-23-039 , U01 and RFA-CA-23-041 , U24 ). The Contact PD/PI can be an MPI or a Co-I on another application, whether for this NOFO or the companion NOFOs. An MPI on a PCA Research Center application may be an MPI or a Co-I on another application, whether in response to this NOFO or the companion NOFOs.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity

• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

PCA HTAN Team
National Cancer Institute (NCI)
Telephone: 240-276-6224
Email: [email protected]

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

For this specific NOFO, the Research Strategy must not exceed 30 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

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

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

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

Specific names provided for Other Attachments must be no more than 50 characters including spaces.

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instruction:

• Please review Section 1. Funding Opportunity Description: Required Capabilities of the PCA Research Project to ensure that the application includes all necessary expertise.
• The PCA Research Project must have a designated Project Manager who will liaise with NCI Program Officials and the DCC. Although the Contact PD/PI is expected to serve as the Project Manager, another person can be designated to fulfill this role.
• Other key personnel may include, but are not limited to, a research coordinator, surgical nursing staff, and/or laboratory technicians.
• Key personnel responsible for the biospecimen acquisition, processing, and annotation function must have expertise in collection, annotation, and characterization of clinical biospecimens.
• Key personnel responsible for the molecular, cellular, and spatial characterization must have expertise in multidimensional, multimodal, multiplex and spatial profiling of human tissue samples.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

a) PD(s)/PI(s) Effort: For single PI applications, a minimum of 1.8 person month of their time per year must be committed. For multi-PD/PI applications, the Contact PD/PI and all other PDs/PIs must commit a minimum of 1.2 person month of their time per year to the award. Commitment cannot be reduced in later years of the award below the levels stated above.

b) Set-Aside Funds for HTAN Pilot Projects and Trans-Network Projects (TNPs): Applicants must set aside 15% (Direct Cost) of their annual budget in Years 2-5 to facilitate the testing of hypotheses derived from atlas construction and to develop TNPs. The set-aside amount should be presented in the "Other Direct Costs" category under the heading Consortium Collaborative Funds". The use of the set-aside funds will be restricted until pilot projects and/or TNPs are developed. These pilot and collaborative studies will be developed in the last quarter of Year 1 and will be subject to evaluation by the Steering Committee and NCI authorization. Use of the restricted funds will be contingent upon the recommendation of the Steering Committee. Examples of such projects include testing of HTAN-derived hypotheses in appropriate pre-clinical systems (this could include PDX, patient-derived organoids, or other mammalian systems) or validating an emerging theme (e.g., specific cell-cell interactions) from the HTAN Projects spanning across multiple cancer transitions and/or cancer types. The TNP topics are subject to discussion after the launch of the second phase of HTAN. Do not include a description of pilot projects or TNPs within the application.

c) Support for Early-stage/Junior Investigators: The budget should include funds to enhance professional development (e.g., participation in projects, attendance of meetings) of early-stage/junior investigators. Activities can include, but are not limited to, participation in cross-consortium junior investigator meetings (i.e., the NIH Junior Atlas Builders meeting).

d) Travel Funds: Applicants must budget for travel and per diem expenses for biannual HTAN in-person meetings. At a minimum, the Contact PD/PI together with at least one MPI, or other senior investigator, and an early-stage/junior investigator will attend two in-person HTAN meetings each year of the award. The NCI intends to conduct at least one virtual site visit in the 5-year funding period, so travel funds will not be needed for this purpose.

R&R Subaward Budget

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

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

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

Specific Aims:?In addition to the specific aims, applicants should succinctly describe the atlas to be constructed by the PCA Research Center. While the type of precancerous lesion is not being prescribed, a clear understanding of the progression being investigated must be provided and a statement regarding how the atlas significantly adds to the current repertoire of HTAN atlases and contribute toward cancer prevention, risk assessment and/or early detection.

Research Strategy: In lieu of the standard Research Strategy subsections, applicants should use the subsections defined below to present a concise plan for the proposed PCA Research Center. For this specific NOFO, the Research Strategy section is limited to 30 pages. Suggested/recommended page lengths are mentioned in parentheses.

Subsection A: Proposed Precancer Atlas Overview (2 pages)

• Describe the precancerous lesion atlas that will be constructed and how it will contribute to the understanding of the progression of precancerous lesions to invasive cancers.
• Provide background and rationale for the selection of tissue type and outline the significance and potential impact provided by the atlas.
• Describe the envisioned final structure of the atlas, including the types of data to be collected and plans for visualization and what additional information the atlas will provide beyond what is available in current publicly accessible big-data efforts. Include information on what challenges will need to be overcome to effectively share data and how they could be addressed through HTAN scientific working groups, HTAN-DCC and the NCI Cancer Research Data Commons.
• Briefly describe how the atlas might be employed by the scientific and clinical communities.
• Provide one use case that illustrates how the proposed atlas datasets could be utilized to build a predictive model.

Subsection B: Research Team (2 pages)

This subsection should provide a concise description of the team structure of the Research Center including:

• How the team brings complementary multidisciplinary scientific expertise required for the integration of multidimensional, multiparametric data to build an atlas to address the key biological/clinical research problem proposed.
• How the diverse expertise of the team members increases the capability for innovation, the ability to anticipate new directions, and the flexibility to redirect research when needed.
• The research team should be composed of a team of at least three (2-3) investigators, including one early-stage investigator (ESI). The junior investigator/ ESI may hold the title of Postdoctoral Fellow, Staff Scientist, Research Associate, Instructor, Assistant Professor, or equivalent and should be within 6-8-years following completion of a professional degree or subsequent mentored academic or clinical training program.

Subsection C: Integrated Functions of the PCA Research Center (12 pages)

PCA Research Centers must be organized around three integrated functions: (1) Biospecimen acquisition, processing, and annotation, (2) Molecular, cellular, and spatial characterization, and (3) Data processing, analysis, modeling, and visualization. Applicants must address how they will fulfill these functions and present an overall project management plan. Preliminary data demonstrating the Center’s capabilities required to perform these functions should be provided. Applicant should also review the information in the Specific Research Objectives and Scope of the PCA Research Center section under Section I. Funding Opportunity Description.

Biospecimen acquisition, processing, and annotation

Describe the methods used for the identification, collection, preservation, labeling, and quality control of all biospecimens used to construct the proposed atlas. At a minimum, provide the following information:

• A biological and statistical justification for collection frequency, sample type, and volume of biospecimens to be acquired that are relevant to the specific atlas being proposed by the PCA Research Center. Applicant must specifically address the requirement to include biospecimens from a diversity of patient populations in (see Sub-section D: Addressing Cancer Health Disparities).
• Evidence of access to human biospecimens (i.e., ongoing clinical trial or other ongoing study that is accruing patients) relevant to the proposed atlas.
• Information on quality assurance and quality control metrics employed to ensure high sample quality upon collection, after preservation, and upon pre-analytical processing. Provide parameters that define sample quality. Include information about how tissue will be processed and/or preserved to facilitate the molecular and spatial characterization of the biospecimens.
• A short description of retrospective human samples, non-human tissues and/or alternative in vivo and/or ex vivo human models that maybe used in the conduct of the proposed research. Data contained in the final atlas developed by the PCA Research Center is to be derived from human clinical biospecimens, preferably prospectively collected. However, it is recognized that biospecimens from retrospective studies, non-human models or in vivo and ex vivo platforms derived from human tissues or tumors, such as tumor organoids, patient-derived xenograft models, and other systems that maintain native tissue and or tumor architecture may be useful during development of standard operating procedures for tissue processing, preservation, and characterization and during testing of atlas-derived hypotheses.
• If applicable, address how diverse locations of the project personnel may or may not influence downstream processing. Describe and, preferably, demonstrate through presentation of preliminary data strategies to minimize confounding variables during sample collection.

Molecular, cellular, and spatial characterization

Describe methods that will be used to characterize the biospecimens that will be used to develop the precancer atlas. At a minimum, provide the following information:

• A biological and statistical justification for types and volumes of data to be acquired that will be used to construct the atlas.
• Assay methods and platforms to be employed, their reproducibility and preliminary data that demonstrate their use within the context of the proposed atlas construction. Note that it is required that each atlas include at least two common HTAN data types (one must be a spatial data type) for which data and metadata standards have been developed (https://data.humantumoratlas.org/standards).
• A strategy to monitor and ensure data quality, including action plans for when quality issues are discovered. Applications should describe typical error rates for the proposed assay methods and technology platforms. Identify an individual who will participate in data quality assurance activities across the entire HTAN.
• The expected data collection workflow, QA/QC points, and potential challenges associated with the analysis of small or variable samples.
• A plan for how biospecimens will be divided for analysis If technology platforms are located across different institutions.

Data processing, analysis, modeling, and visualization

Describe methods that will be used for data processing, analysis, modeling, and visualization of atlas data. At a minimum, provide the following information:

• Methods that will be used to process and analyze the molecular, cellular, and spatial data generated by the PCA Research Center. Methods for modeling and visualization should also be described.
• Existing or proposed data processing pipelines to be employed by the PCA Research Center, specifically in regard to imaging, spatial and omics data. State the degree to which the resulting processed data is interoperable and meets the qualifications for FAIR data sharing standards. If standard data processing pipelines are not being employed within the Center, provide justification for the use of in-house pipelines and provide examples of downstream analyses utilizing the output of the data processing pipeline (to demonstrate interoperability).
• The different levels of ontologies that will be utilized to describe information within the atlas.
• Plans for how the resulting human precancer atlas dataset can be utilized to build a predictive computational model of progression from a precancerous lesion to an invasive cancer. Describe the clinical or biological insight that can be gained from the modeling effort and steps required to test hypotheses derived from the modeling effort.
• Plans to aggregate and integrate data and metadata from the broad range of experimental and computational approaches outlined throughout the application into a precancer atlas.
• Investigators ability to incorporate disparate data types generated by other members of the HTAN and provide evidence of collaboration and/or use of open-source algorithm and computational tool development. Analytical flexibility is an important aspect of the Research Center because final breadth of data types developed by the Network remains to be determined.

Note on Informed Consent

Biospecimens collected by the PCA Research Center will be characterized using the technology platforms proposed in the application, including the potential for new and cutting-edge data collection techniques that are not currently used in any PCA or HTA Research Center. Therefore, careful attention must be given to the design of patient consent forms at the time of specimen collection. Consent forms must allow for broad data sharing as required by the Beau Biden Cancer Moonshot Public Access and Data Sharing Policy. Include an approved consent form in the Appendix materials or provide evidence that approval is expected.

Subsection D: Addressing Cancer Health Disparities (1 page)

As outlined in the 2023 National Cancer Plan, research efforts are encouraged to address the needs of racially and ethnically diverse populations, and those from urban and rural areas who are poor and medically underserved, and those who continue to suffer disproportionately from certain cancers that have higher morbidity and mortality rates. All HTAN atlases should contain a diversity of patient populations consistent with the requirements of the NIH Inclusion Policies for Research Involving Human Subjects. NCI is especially interested in applications where samples are collected from patients whose self-identified racial and ethnic communities are expected to have genetic ancestries currently underrepresented in cancer research, underserved populations, or populations who experience disparate cancer outcomes. In all cases, applicants are strongly encouraged to, at a minimum, mirror the demographic distribution reported by the U.S. Census Bureau. Consequently, applicants must address how the proposed atlas will impact people historically underserved or excluded from biomedical research and the benefits derived thereof. Highlight any opportunities derived from atlas construction that, if implemented, could reduce disparities in cancer incidence, diagnosis, and/or outcome. Provide detailed information on any specific community outreach and/or education efforts. Explain how the proposed sample collection scheme will contribute to capacity and/or trust building within the communities being served. Detail any new or ongoing initiatives that will encourage a patient-as-partners viewpoint.

Subsection E: Project Management Plan (2 pages)

Outline the organization PCA Research Center. Describe the lines of responsibilities, including, as applicable, the effort distribution across the participating institutions (i.e., institution submitting application and participating institutions on a sub-contractual basis).

Benchmarks of Progress

Applicants should provide benchmarks for each specific aim. Outline benchmarks with quantitative metrics that will document progress towards the achievement of the overall Center milestones. Applicants should include plans for critically evaluating and revising these benchmarks on a regular basis. Applicants should describe how they will prioritize their activities to ensure that the main goals of the PCA Research Center will be achieved. Benchmarks may be revised at the time of the award with approval by NCI Program Officials.

Network-wide Collaboration

Describe plans to collaborate with the HTAN Data Coordinating Center and other HTAN Research Centers in developing common data formats and interoperable tools and procedures allowing seamless integration and presentation of the atlases across the entire HTAN. Additionally, describe how analysis workflows or pipelines will facilitate consistent use of the algorithms by numerous experimental labs.

Demonstrate through evidence of collaboration and/or open-source algorithm and computational tool development the flexibility of the Data Analysis Unit to incorporate disparate data types generated by other members of the HTAN. Analytical flexibility is an important aspect of the Data Analysis because the HTAN has not yet formed and the breadth of data types across the Network is currently unknown.

Letters of Support: In addition to standard items, applicants must provide letters from the respective leadership official(s) in the institution(s) documenting specific institutional commitments for the PCA Research Center. Letters should also be included that reflect any additional resources and partnerships (e.g., collaborators, non-profit organization, industry, large cohorts) that will be employed to achieve the goals of the Center. If applicable, letters should clearly document sample accessibility, timelines, and alternative plans if sample collection delays are encountered.

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan as outlined in the NIH Grants Policy Statement. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

• All applicants are required to adhere HTAN policies and the Beau Biden Cancer Moonshot Public Access and Data Sharing Policy.

All applicants are required to adhere HTAN policies and the Beau Biden Cancer Moonshot Public Access and Data Sharing Policy.

Only limited Appendix materials are allowed. 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 (and when applicable, clinical trials research experience) 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 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.

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

3. Unique Entity Identifier and System for Award Management (SAM)

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). 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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.

5. Intergovernmental Review (E.O. 12372)

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.

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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 (CSR) and responsiveness by 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

Section V. Application Review Information

1. Criteria

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.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission (https://grants.nih.gov/grants/guide/url_redirect.php?id=11149) are evaluated for scientific and technical merit through the NIH peer system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project 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 project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO:

How strong is the translational potential of the proposed atlas in terms of increasing the understanding the biology of the progression of precancerous lesions to cancer, and identifying targets for cancer prevention or biomarkers for risk assessment or early detection?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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 NOFO:

• How strong is the PD(s)/PI(s)' demonstrable expertise to fulfill the three areas of integrated responsibility: (1) biospecimen acquisition, processing, and annotation, (2) molecular, cellular, and spatial characterization, and (3) data processing, analysis, modeling, and visualization?
• How well does the interdisciplinary balance between translational and clinical researchers match the scope and goals of the proposed research and the overall goals for the HTAN?

Innovation

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

Specific to this NOFO:

To what extent does proposed precancer atlas employ and rationalize strategies for integrating and visualizing large-scale molecular, immunological, cellular, non-cellular and clinical datasets and/or predictive modeling?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the 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 project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals 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 NOFO:

• How well does the applicant’s preliminary data support their capability to construct the proposed atlas? Does the rationale for the proposed organ site(s) follow the recommended criteria (impact on public health, access to technologies and biospecimens, feasibility of atlas construction, and synergistic partnerships for maximizing resources) outlined in the NOFO?
• How clearly do the applicants describe a delineated and integrated Project Management Plan that has the potential to lead to successful atlas construction?
• How reasonable and achievable are proposed timeline and milestones?
• How clearly do the investigators document their access to the appropriate cohorts and/or their ability to collect longitudinal biospecimens?
• How does the applicants plan to achieve a diverse sample set consider the patient population that will be sampled?

Environment

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

Specific to this NOFO:

• How well the scientific environment described in which the work will be done contribute to the probability of success?
• How strong is the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed?
• How conducive is the environment to meet the needs of project in relation to subject populations, or collaborative arrangements?

Additional Review Criteria

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

Integration

• Will the proposed PCA Research Center be a truly integrated entity, rather than a collection of unrelated research ventures and support services?
• How well does the PCA Research Center organization promote scientific and administrative integration, synergy, and a cohesive research goal?
• How well do the proposed interactions and collaborations between the PCA Research Center PD(s)/PI(s), Unit Leads, and other key personnel unite the components and advance the atlas building efforts of the Research Center?
• How sufficient is applicant's stated evidence of their willingness to collaborate and share samples, data, software, and other resources within the PCA Research Centers and across the Network?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of 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.

Vertebrate Animals

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 Animals Section.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, NIH 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 will receive a written critique.

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.

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

Applications will be assigned to NCI. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• The potential for the proposed atlas to add significant value to the current set of HTAN atlases.
• The potential for the proposed atlas to benefit the full diversity of patients within the United States.
  

3. Anticipated Announcement and Award Dates

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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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: Recipient 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2 CFR Part 200, 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

Primary responsibilities of PD/PIs

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

• Overseeing the scientific research, analyzing and interpreting research data, reporting results to the scientific community, and disseminating approaches, methods, models, software, and tools broadly.
• If there is only one PD/PI named on the award, the PD/PI must maintain a minimum of 1.8 person-months of effort per year.
• If it is a multiple PD/PI award, every PD/PI must maintain a minimum of 1.2 person-months of effort per year.
• Being an active participant in the HTAN, including attending the semi-annual HTAN meeting, participating in other network sponsored meetings and workshops, and participating in collaborative activities.
• Serving on the HTAN Steering Committee. The PCA Research Center PD(s)/PI(s) (i.e., contact PD/PI and multi-PD(s)/PI(s)) are required to serve as members of the Steering Committee.
• Abiding by the governance policy of the HTAN and all program policies agreed upon by the HTAN Steering Committee and approved by NCI Program Officials to the extent consistent with the applicable rules and regulations, including current HTAN policies.
• Reporting all research progress and outreach activities annually to the NCI Program Officials. The PD(s)/PI(s) will provide additional information, outside the scope of the standard reporting requirement, as needed and requested by NCI Program Officials.
• Preparing and arranging logistics for site visits by NCI Program Officials.
• Participation in NCI-coordinated evaluation of the HTAN program.
• Leveraging, where feasible, technology from other NCI-sponsored informatics initiatives, for example the NCI Informatics Technology for Cancer Research (ITCR) program.
• Coordinating with and leveraging, where feasible, the technology of the NCI Cancer Research Data Commons.
• In accordance with HTAN and NIH/NCI policies, depositing data, models, software, and other tools and resources at HTAN Data Coordinating Center (DCC) where they are made publicly available in accordance with the Beau Biden Cancer Moonshot Public Access and Data Sharing Policy and the NIH Data Management and Sharing Policy.
• Utilizing the resources within the HTAN Data Coordinating Center, including common data elements and metadata dictionaries developed in collaboration with HTAN investigators.
• Publishing results from research conducted the PCA Research Center in a timely manner.
• Organizing and actively participating in scientific working groups to facilitate collaborative projects and cross-testing of experimental and analytical concepts.

Recipient’s 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 DHHS, PHS, and NIH policies.

Primary Responsibilities of NIH Program Staff

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The substantially involved NCI program staff member(s), acting as Project Scientist(s), will coordinate in a centralized fashion the various activities of the recipients.

In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, NCI will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act.?NCI also reserves the right to modify the budget or duration of funding or to curtail an award in the event of: (a) substantive changes in the project not approved in advance, (b) use of funds for activities not within the scope of the specific aims, (c) failure to make sufficient progress toward the project milestones, including timely pre-publication deposition of data or reagents in accordance with approved Consortium Policies, (d) failing to comply with the terms and conditions of the award or establish necessary statutory, regulatory, policy approval required for conducting the project, or (e) ethical or conflict of interest issues.

Specific responsibilities of the NCI Project Scientist(s) will include, but will not be limited to:

• One or more designated NCI Program staff members will have substantial scientific and programmatic involvement as Project Scientist(s) for the HTAN.
• Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
• Serving as non-voting members of the HTAN Steering Committee.
• Assisting the Steering Committee, the HTAN DCC and individual Research Centers in avoiding unwarranted duplications of effort across the HTAN.
• Facilitating collaborative research projects which involve multiple HTAN Research Centers that would be suitable for consideration as a trans-HTAN collaborative project to be funded by the Research Centers restricted funds.
• Assisting recipients to broaden their interactions with other NCI and NIH programs to disseminate results, tools, and models from the HTAN and take advantage of existing NIH/NCI resources and infrastructures. This will include acting as a liaison between the HTAN and other atlas-building programs.
• Convening and providing oversight to the PCA Sub-Committee in executing the projects as listed in the funded application and facilitating collaboration across PCA Research Centers.
• Ensuring that the HTAN DCC’s data and tool sharing infrastructure is provided to HTAN members in a reasonable and expeditious way.
• Ensuring consortium-wide adoption of data-sharing and tool-sharing and interoperability practices.
• Monitoring the operations of HTAN awardees and making recommendations on overall project directions and allocations of PCA and HTA Research Center funds.
• Reviewing the progress of the HTAN awardees (including HTAN DCC), conducting periodic site visits.
• Participating in organizing semi-annual HTAN meetings, specialized workshops, and HTAN webinars.
• Participating in frequent planning and coordinating activities with the HTAN DCC.

External Program Consultants:?As part of the HTAN program, NCI program staff will engage 5-10 external consultants (EPCs); investigators who are not part of HTAN but have relevant scientific expertise and experience working with consortia to provide input and advice to NCI program staff. This could include reviewing and evaluating the progress of the entire HTAN as well as recommending changes in priorities for HTAN based on scientific advances within and outside the Network. NCI is solely responsible for appointing EPCs for variable durations of service. EPCs, who agree to a confidentiality policy, are invited to participate in Network meetings, Steering Committee calls and the biannual investigator meetings. A subset of EPCs may also meet virtually at other times of the year, as needed. Annually, the EPCs will provide individual assessments to NCI program staff on the progress of the Network and will present individual expert recommendations regarding any changes in the HTAN as necessary.

Areas of Joint Responsibility

Steering Committee: The Steering Committee will be the main HTAN governing body. The Steering Committee will be composed of one representative (contact PD/PI for multi-PI award and PI for single PI award) from each HTAN awardee, i.e., from HTA Research Centers, PCA Research Centers, and the HTAN DCC who will have one vote each.

NCI Program Officials will participate in HTAN Steering Committee meetings as non-voting members and will provide final approval of HTAN policies.

Two PD(s)/PI(s), representing two different HTAN awards, will be selected to serve as chairpersons of the Steering Committee starting at the first meeting of the Steering Committee following awards issuance. It is expected that most HTAN decisions will be made by consensus, but decisions and recommendations that require voting will be based on a majority vote.

The HTAN Steering Committee will meet monthly by video-conference and in-person at the HTAN biannual Steering Committee Meeting and as needed.

The HTAN Steering Committee will:

• Identify scientific and policy issues that need to be, or can benefit by being, addressed at the Network level and develop recommendations to NCI Program Officials for addressing such issues.
• Review progress of the HTAN toward meeting the overall Network goals.
• Ensure that all HTAN members utilize the resources developed by the HTAN DCC.
• Discuss and prioritize the collaborative projects to be supported by the restricted "HTAN Pilot and Trans-Network Projects" funds within each Research Center.
• Coordinate, organize, and disseminate Network output to the broader cancer research community, potentially including the organization of coordinated publications and/or presentations.
• Ensure that the Network takes advantage of existing NCI and NIH resources and programs.
• Establish, as necessary, working groups, special interest groups, or subcommittees to accomplish the goals of the HTAN program.

PCA Sub-Committee: The PCA sub-committee will be composed of all PCA Research Centers PIs. Other HTAN investigators, NCI Program Staff, and ad-hoc members are encouraged to participate. PCA Sub-committee will focus on scientific and administrative directions for PCA and integration of efforts across PCA Centers. The PCA sub-committee is required to report to the HTAN Steering Committee on a regular basis.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between 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 recipient. This special dispute resolution procedure does not alter the recipient'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.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.

Section VII. Agency Contacts

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: https://www.era.nih.gov/need-help (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: 301-480-7075

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

Sudhir Srivastava, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-7028
Email: [email protected]

Nicholas Hodges, PhD
National Cancer Institute (NCI)
Telephone: 240-309-8155
Email: [email protected]

Indu Kohaar, PhD
National Cancer Institute (NCI)
Telephone: 240-620-0875
Email: [email protected]

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

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6885
Email: [email protected]

Section VIII. Other Information

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 and 2 CFR Part 200.