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

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications for Human Tumor Atlas (HTA) 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 (3D) 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 HTA Research Center will construct one human precancer or advanced cancer atlas with an explicit focus on how evolving spatial relationships contribute to important transitions in cancer from tumor initiation to metastasis. The other two HTAN components are Precancer Atlas (PCA) Research Centers and a Data Coordinating Center (DCC). Each PCA Research Center will construct one 3D precancer atlas that comprehensively characterizes a premalignant lesion with an explicit focus on understanding the transition from a precancerous lesion to malignancy. The DCC will serve the dual role of network and data coordination. It will also be responsible for meeting coordination. 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.

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 local recurrence and/or metastasis, and response and/or resistance to treatment. The original Funding Opportunity Announcements were RFA-CA-17-034 (HTAN-HTA), RFA-CA-17-035 (HTAN-PCA) and RFA-CA-17-036 (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 and 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. More information regarding available HTAN atlases, datasets, protocols, and analytical tools can be found at www.humantumoratlas.org.

There are several organized single-cell atlas programs funded by the NIH (HuBMAP, SenNet, BRAIN Initiative Cell Census Network, GUDMAP, LungMAP) as well as the international community (Human Cell Atlas, Chan Zuckerberg Initiative Seed Networks) that are focused on building molecularly resolved atlases of non-diseased tissues. Additional efforts are systematically mapping specific non-malignant (NIH Kidney Precision Medicine Program, Helmsley Gut Atlas) or premalignant (Gray Foundation BRCA Team Science Project) disease states. HTAN investigators will be encouraged to participate in events, special interest groups, and/or working groups that promote collaboration and resource sharing across atlas efforts.

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 HTA and PCA Research Centers.

• The cancer 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 to collect 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).
• 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:

• HTA Research Centers (RFA-CA-23-039) will construct atlases describing one or more transitions spanning the entire cancer continuum: precancer to locally invasive cancer, early invasive cancer to more advanced stages and metastatic cancer, relapse/local 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.
• 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.

These atlas-building initiatives will be supported by the HTAN DCC (RFA-CA-23-041) 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 HTA Research Centers

The objective of each HTA Research Center is the construction of no more than one tumor atlas that describes the molecular, cellular, and tissue-level spatial, functional, and/or temporal relationships of cellular and non-cellular components of the tumor ecosystem.

Multimodal mapping requirement: HTA Research Centers must include multimodal technological platforms for molecular, cellular and tissue characterization of selected biospecimens and leverage the existing HTAN infrastructure and assay types to establish a well-informed decision on the selection of modalities for robust data generation. As mentioned earlier, the plan should include at least two existing HTAN data types for which data and metadata standards and levels exist (at least one must be a spatial assay).

Spatial mapping requirement: HTA Research Centers should aim to quantify the 3D characteristics of tumor evolution. Atlases derived from technologies that ensure maximum information preservation within the 3D tumor microenvironment are desired. Furthermore, atlases constructed using only bulk or dissociative-omics technologies in the absence of a spatial (2D or 3D) mapping focus will be considered non-responsive (i.e., only single-cell DNAseq, RNAseq or ATAC-seq, or mass spectrometry-based proteomics, glycomics or lipidomics).

Dynamic mapping requirement: Atlases must include detailed clinical data matched to patient biospecimens to guide analysis of the spatially reconstructed molecular, cellular, or tissue dynamic phenotypes that predict tumor initiation, progression, locoregional recurrence, metastasis, and response and/or resistance to therapy. Tumor atlases supported under this NOFO must focus on one of the following transitions in cancer:

• The transition from non-malignant to malignant disease, including, but not limited to, atlases characterizing precancer or carcinoma in situ lesions and matched recurrent non-malignant lesions and advanced cancers from the same patients, and precancers and other atypical lesions found in surgically resected specimens or rapid autopsy specimens in association with invasive cancers.
• The transition from locally invasive to more advanced stages and metastatic cancer, including, but not limited to, atlases characterizing multiple metastatic sites, atlases describing the transition into or out of tumor dormancy, atlases capturing colonization of early disseminated tumor cells at distant sites.
• The locoregional recurrence of disease within the same patient following treatment of the primary cancer.
• The dynamic response to therapy, including, but not limited to, atlases describing a positive response to traditional, targeted and/or immunotherapies, atlases that describe no response, incomplete response, or negative response to traditional, targeted and/or immunotherapies.
• The development of therapeutic resistance, including atlases describing the transition from responsive to traditional, targeted, and/or immunotherapy to resistant to that therapy.

Atlas use case requirement: The proposed atlas should generate testable hypotheses based upon a specific and timely use case that is clearly defined within the application. For example, atlas driving use cases might include, but are not limited to:

• Discovery and validation of emergent tumor behaviors, such as tumor plasticity, recurrent cellular neighborhoods, stable or transient molecular or cellular gradients, morphomechanical relationships, and/or cellular cooperative behaviors, etc. that can only be recognized through spatial tumor reconstruction;
• A quantitative, spatially aware atlas of tumor-microenvironment co-evolution and/or cell-cell communication during tumor development, treatment, or metastasis that suggests more accurate tumor staging or treatment plans;
• A spatial map of how genotype relates to 2D and 3D phenotype during the transition from an abnormal tissue state to malignancy, from locally invasive cancer to metastatic disease, or as tumors become resistant to therapy; or
• Connection of molecular genotypes, circulating factors, and/or multi omics data to image-measured cell responses/phenotypes in human samples to guide therapy development or treatment decisions.

Testing of subsequent hypotheses, which is allowable via use of set-aside funds within the HTAN structure, should generate biological insight with strong translational potential. Of note, the development of projects for utilization of set-aside funds will be achieved after the launch of the Network.

Tumor type or tissue type requirement: Proposed atlases that add significant value to the current set of HTAN atlases (www.humantumoratlas.org) will be considered high priority. 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;
• Addressing a cancer type of major public health concern and of high clinical priority, such as cancers with a clear disparity in outcome across populations.

As outlined in the 2023 National Cancer Plan, NCI is focused on addressing the needs of racially and ethnically diverse populations and those from urban and rural areas who are economically and medically underserved, as well as those who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates. All atlases generated by HTA Research Centers will contain 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). 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.

HTA Research Centers Organization?

HTA 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 applicable. It is strongly suggested that applicants consider analysis of samples in partnership with ongoing clinical trials or well-established, cancer-specific tissue resources (i.e., Cooperative Human Tissue Network).

The type and frequency of biospecimen collection will depend on the driving use case of the proposed atlas (i.e., which cancer type and which transition is being addressed, as well as the clinical setting serving as the key source for the biospecimens). Information pertaining to biospecimen collection, including but not limited to, clinical and epidemiological data and metadata, pathologic analysis, anatomic location (including information about coordinates and/or 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.

Molecular, cellular, and spatial characterization: The goal of an HTA 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 precancer and/or tumor ecosystem. 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, 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: In this function, HTA 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 cancer. The proposed use cases can utilize HTAN set-aside 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 with 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://data.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), PCA Research Centers (RFA-CA-23-040, U01), and an 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 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

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

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 HTA Research Center application must not be the designated Contact PD/PI of another application under this NOFO or under the companion NOFOs (RFA-CA-23-040 and RFA-CA-23-041). 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 an HTA 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:

NCI 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, with the following exceptions:

For this specific NOFO, the Research Strategy section should 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.

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

• Please review Section 1. Funding Opportunity Description: Required Capabilities of the HTA Research Project to ensure that the application includes all necessary expertise.
• The HTA 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.
• Key personnel responsible for data processing, analysis, modeling, and visualization function must have expertise in analysis of large-scale, multidimensional, multimodal, and spatial data sets from human tissue samples.
• 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 of completion of a terminal research degree or a clinical training program

R&R or Modular Budget

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

a) PD(s)/PI(s) Effort: For single PD/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 Research Centers 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 generated by the HTA Research Center. As mentioned earlier, the tumor type is not being prescribed, but a clear understanding of the important cancer transition being mapped must be provided and a statement regarding how the atlas significantly adds to the current repertoire of HTAN atlases should be included.

Research Strategy: In lieu of the standard Research Strategy sub-sections, applicants should use the sub-sections defined below to present a concise overall vision and plan for the proposed HTA Research Center. Applicants may include other sub-sections, if needed, but must include the information requested below.

Applicants are strongly suggested, but not required, to limit the sub-sections to the following page lengths:

Sub-section A: Proposed Atlas Overview (2 pages)

In this sub-section address the following aspects of the HTA Research Center:

• Define the precancer or cancer atlas that will be constructed within the HTA Research Center and how it addresses at least one of the high-priority transitions in cancer as defined in the Research Objectives section. Outline the significance and potential impact of the atlas on the field.
• Provide background and rationale for the selection of tissue or tumor type and selection of technological approaches.
• Explain how the atlas adds significant value to the currently available HTAN atlases.
• Succinctly describe the envisioned final structure of the spatial atlas to be created, including the nature of the data and plans for visualization of the data, the target user base and what additional levels of information the atlas will provide beyond what is available via current publicly accessible big-data and/or single-cell efforts.

Sub-section B: Research Team (2 pages)

This sub-section should provide a concise description of the team structure of the Research Center including, at a minimum, the following aspects:

• How the skills of individual team members will translate into the collective capability of the HTA Research Center to accomplish the stated atlas construction goals.
• 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 of completion of a terminal research degree or a clinical training program.

Sub-section C: Integrated Functions of the HTA Research Center (12 pages)

The HTA 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. The strongest applications will demonstrate the proposed atlas building pipeline from sample identification and collection through analysis and predictive modeling of the resulting atlas dataset. Applicant should also review the information in the Specific Research Objectives and Scope of the HTA Research Center section under Section I. Funding Opportunity Description. Describe a plan for sharing samples, data, software or any other useful resources within the HTA Research Center and with members of the HTAN.

Biospecimen acquisition, processing, and annotation

This functional unit is responsible for identification, collection, preservation, labeling, and quality control of all biospecimens used to construct the proposed atlas and must be founded upon strong biospecimen science. At a minimum, provide the following information:

• A biological and statistical justification for biospecimen collection frequency, sample type, and volume of biospecimens to be acquired that is motivated by the specific atlas use case being proposed by the HTA Research Center. Applicant must specifically address the requirement to include biospecimens from a diversity of patient populations (see Sub-section D: Addressing Cancer Health Disparities).
• Evidence of access to a source of human samples and epidemiological and clinical data (i.e., ability to recruit patients and/or a prospective cohort, ongoing clinical trial or other approved and accruing cancer-related study) relevant to the proposed precancer or tumor atlas immediately upon award. Provide information on how samples will be tracked within the Center.
• Information regarding the quality assurance (QA) and quality control (QC) metrics employed to ensure high sample quality upon collection, after preservation, and upon pre-analytical processing. Include information on how tissue will be processed and/or preserved to facilitate biospecimen characterization activities, including optimization of pre-analytical processing of tissue for multiple imaging and omics assays.
• Because histopathological examination remains important and serves as the gold standard for clinical diagnosis, describe how the biospecimens submitted for characterization will be verified by trained pathologist(s) to ensure that the samples meet the protocol guideline standards. Describe how morphologic information will be preserved for correlation with characterization data.
• If applicable, address how disparate geographical locations of the Center personnel may or may not influence downstream processing and the activities related to sample characterization. Describe and, preferably, demonstrate through presentation of preliminary data strategies to minimize confounding variables during sample collection and processing.

Molecular, cellular, and spatial characterization

This functional unit is responsible for data generation via multidimensional molecular, cellular and spatial characterization of all biospecimens proposed to be utilized for atlas construction. Note that it is required that each atlas include at least two common HTAN data types for which data and metadata standards have been developed (one must be a spatial data type). At a minimum, provide the following information:

• A workflow that addresses the multimodal, spatial and dynamic mapping requirements outlined in the Specific Research Objectives and Scope of the HTA Research Center section under Section I. Funding Opportunity Description.
• A biological and statistical justification for data collection frequency, data type, and data volume to be acquired that is motivated by the specific atlas use case proposed by the HTA Research Center.
• The data collection technology(ies)/platform(s) to be employed. Each technology platform is expected to be reliable and reproducible with preliminary data demonstrating its use within the context of the proposed tumor atlas.
• A strategy to monitor and ensure data quality across the HTA Research Center, including action plans for when quality issues are discovered. Applications should describe typical error rates for the proposed technology platforms. Identify an individual who will participate in data quality assurance activities across the HTAN.
• The expected data collection workflow, including all technologies and QA/QC points, and potential challenges associated with small or variable sample dimensions (i.e., needle biopsies).
• If technology platforms are located across Institutions, provide a plan for how biospecimens collected will be divided (or not) for analysis.
• How the team will take advantage of the HTA Research Center infrastructure and the HTAN program to allow for alternative approaches or perspectives to be quickly employed.

Data processing, analysis, modeling, and visualization

This functional unit is responsible for data processing, analysis, modeling, and visualization of atlas data. Additionally, personnel named to this function must work closely with all Center members to quickly determine data quality and provide feedback for rapid course correction. Personnel within this functional unit are also responsible for demonstrating the value of the atlas dataset through identification and coordination of atlas use cases. At a minimum, provide the following information:

• Plans for completion of at least one use case example that will demonstrate how the resulting human tumor atlas dataset can be utilized to build a predictive computational model of cancer. Describe the clinical or biological insight that will be gained from the modeling effort and steps required to test hypotheses derived from the modeling effort.
• Describe and demonstrate any existing or proposed data processing pipelines to be employed within the HTA Research Center, specifically with regards to imaging/spatial and omics data collection. State how these pipelines might be scaled to meet the demands of increased throughput within the HTA Research Center or across the HTAN. 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).
• Describe and demonstrate plans to aggregate and integrate data and metadata from the broad range of experimental and computational approaches outlined throughout the application into a tumor atlas. At a minimum, include the following information:
  • Describe how dynamic spatial relationships will be reconstructed or maintained within the proposed tumor atlas through employment of image analysis and visualization approaches.
  • Address how anatomical relationships will be maintained within the tumor atlas. The importance of precision registration between in vivo and ex vivo data sets may vary in importance for clinical predictions depending on the atlas proposed. If applicable, a theoretical discussion concerning the importance of in vivo to ex vivo registration methodology and how it might subsequently be realized/applied in a clinical environment should be included.
  • Describe the different levels of ontologies that will be utilized to describe information within the atlas.
  • Demonstrate through evidence of collaboration and/or open-source algorithm and computational tool development the flexibility to incorporate disparate data types generated by other members of the HTAN. Analytical flexibility is an important aspect because the breadth of data types developed by the Network remains to be determined.

Note on Informed Consent: Biospecimens collected within the Center will be characterized using the technology platforms proposed herein, including the potential for new and cutting-edge data collection techniques that will be introduced within the HTAN after award. Therefore, careful attention must be paid 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.

Sub-section 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 economically and medically underserved as well as those who continue to suffer disproportionately from certain cancers and 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 (as described in https://grants.nih.gov/policy/inclusion.htm). 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. For applications that propose to focus on precancers or cancers with known health disparities (i.e., triple negative breast cancer, prostate cancer, bladder cancer, etc.), patients from the affected population must be overrepresented within the sample collection plan. In all cases, applicants are strongly encouraged to, at a minimum, mirror the demographic distribution reported by the U.S. Census Bureau and there must be an adequate breadth of samples included within each Center so that future translational research based on the HTAN atlases are beneficial to a diverse population. 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. Detail any new or ongoing initiatives that will encourage a patients-as-partners viewpoint.

Sub-section E: Project Management Plan (1 page)

Applicants must address how they will fulfill the outlined functions and present an overall project management plan. 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). Outline plans of communication within the HTA Research Center to demonstrate a united approach in advancing the atlas building efforts, with NCI Program Officials, and with DCC. Outline plans for evaluation of project progress and measures to mitigate any unexpected challenges. Provide names of key personnel responsible for data management and data deposition to HTAN DCC.

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 HTA 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 project. 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. 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 to 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 and responsiveness by National Cancer Institute (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.

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 rationale for selection of the organ site and precancer or cancer transition(s)? How well does the proposed atlas describe the visualizing of structure, composition, and multiscale interactions at distinct points in the proposed precancer or advanced cancer transition(s)? To what extent does it enhance our understanding of possible mechanisms underlying the transition(s) included in this application and enhance opportunities for translation? How well does the proposed atlas enhance and enrich the data and resources generated in the first phase of HTAN? What is the potential of the atlas to be useful to the diverse population of the United States?

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 adequate is the PD(s)/PI(s) and the larger team's expertise needed to fulfill the three areas of responsibility: (1) biospecimen acquisition, processing, and annotation; (2) molecular, cellular, and spatial characterization; and (3) data processing, analysis, modeling and visualization? How well balanced is the expertise needed for the proposed atlas construction?

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 the atlas provide novel insights into linking genotype and phenotype characteristics in a spatial context, identifying potential biological mechanisms, and help charting novel avenues for tumor risk categorization, and development of prevention and treatment strategies?

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 strong is the study rationale and selection of biospecimens and technological modalities? How sufficient is the applicant's access to biospecimens from appropriate cohorts and/or tissue sources and/or any ongoing clinical trial and is there a strong plan to include biospecimens from diverse US populations? How strong is the biospecimen science (e.g., collection, processing, implementation of measures to recognize and control pre-analytical variables, annotation) and the proposed downstream workflow that entails data generation/integration and linking of multimodal data/modeling approach? How well do the applicant’s preliminary data and expertise support their capability to construct the proposed atlas? How well does the applicant's 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?

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.

Specific for this NOFO:
Integration

• Will the proposed HTA Research Center be a truly integrated and synergistic entity with a cohesive research goal rather than a collection of unrelated research ventures and support services?
• How well do the proposed team organization and communication plan among the Research Center team members unite the functions and support the atlas building efforts?
• Does the applicant indicate willingness to collaborate and share samples, data, software, and other resources within the HTA 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

Not Applicable.

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 the NCI, in accordance with NIH peer review policies and practices, 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 the appropriate NIH Institute or Center. 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 sent 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 (HHS) 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 purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 NIH as defined below.

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

• Overseeing the scientific research of the HTA Research Center, analyzing, and interpreting research data, reporting results to the scientific community, and disseminating approaches, methods, models, software, and tools broadly.
• Committing and maintaining throughout the life of the HTA Research Center a minimum of 1.8 person-months of effort per year for the investigator designated as the contact PD/PI, if there is only one PD/PI named on the award.
• Committing and maintaining throughout the life of the HTA Research Center a minimum of 1.2 person-months of effort per year for any investigator designated as the contact PD/PI or the multi-PD(s)/PI(s).
• Agreeing to be an active participant in the HTAN, including attending the biannual HTAN meetings, participating in other network sponsored meetings and workshops, and participating in collaborative activities.
• Serving on the HTAN Steering Committee. The HTA 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 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 progress to the NCI Program Officials on all HTA Research Center research and outreach activities annually. The PD(s)/PI(s) may be expected to provide additional information, outside the scope of the standard reporting requirement, as needed and requested by Program staff members.
• Being prepared for site visits of NCI Program staff members and participation in the NCI-coordinated evaluation of the HTAN program. The contact PD/PI should coordinate participation in Research Center evaluation activities, including generation of progress reports and logistics of site visits.
• Coordinating with and leveraging the NCI Cancer Research Data Commons infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact.
• Ensuring that data are deposited to the HTAN Data Coordinating Center (DCC) in accordance with HTAN and NIH/NCI policies, and that models, software, and other tools and resources developed as part of this Research Center are made publicly available according to HTAN policies and in accordance with the Beau Biden Cancer Moonshot Public Access and Data Sharing Policy and the NIH Data Management and Sharing Policy. Additionally, all HTAN Research Centers will be required to utilize the resources within the HTAN DCC, including common data elements and metadata dictionaries developed in collaboration with HTAN investigators. The HTAN DCC will be funded under the companion NOFO (RFA-CA-23-041).
• Ensuring that scientific results are published in a timely manner.
• Organizing and actively participating in scientific working groups to facilitate collaborative projects and cross-testing of experimental and analytical concepts.
• Ensuring that HTAN Center personnel participate in atlas-related events, special interest groups, and/or working groups that promote collaboration and resource sharing across atlas efforts.

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. Participating HTA Research Center members are also encouraged to organize and participate in other HTAN meetings and workshops, organize collaborative activities, and promote Trans-Network collaborations, and organize and participate in scientific and programmatic working groups.

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

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.

In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the 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.

The specific roles of the substantially involved NCI staff members include the following activities:

• Serving as non-voting members of the HTAN Steering Committee.
• Assisting the Steering Committee, the HTAN DCC, and individual U01 awardees in avoiding unwarranted duplications of effort across the HTAN.
• Facilitating collaborative research efforts that involve multiple HTAN Research Centers and would be suitable for consideration as a trans-HTAN collaborative project to be funded by restricted funds.
• Assisting the awardees in facilitating their broader 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 specifically include acting as a liaison between the HTAN and other atlas-building programs.
• Ensuring that the HTAN DCC data- and tool-sharing infrastructure is provided to HTAN members in a reasonable and expeditious way.
• Ensuring consortium-wide adoption of data- and tool-sharing and interoperability practices.
• Monitoring the operations of the HTAN awardees and making recommendations on overall project directions and allocations of HTAN Research Center funds.
• Reviewing the progress of the HTAN awardees (including HTAN DCC), conducting periodic site visits, and taking other actions as needed.
• Participating in organizing semi-annual HTAN meetings, specialized workshops, and webinars of the network.
• Participating in frequent planning and coordinating activities with the HTAN DCC and working collaboratively to administer the HTAN program.

External Program Consultants (EPCs):?As part of the HTAN program, NIH staff will engage 5-10 external program consultants (EPCs) not funded as part of the program but with relevant scientific and consortium experience to provide input and advice to NCI Program staff. This could include reviewing and evaluating the progress of the entire HTAN program as well as recommending changes in priorities for the HTAN program based on scientific advances within and outside of the Consortium. The EPCs will be scientific experts who are not directly involved in the activities of the HTAN program and who agree to a confidentiality policy, engaged on an as-needed basis to advise on specific issues.? NCI is solely responsible for appointing EPCs for variable durations of service. EPCs are invited to participate in Consortium meetings and Steering Committees calls and the biannual investigator meetings. A subset of EPCs may also meet by phone or web at other times of the year, as needed. Annually, the EPCs will provide individual assessments to the NCI of the progress of the Consortium and will present individual expert recommendations regarding any changes in the HTAN program as necessary.

Areas of Joint Responsibility include:

Steering Committee: The Steering Committee will be the main governing body for the HTAN. The Steering Committee will be composed of representatives (contact PD/PI and multi-PD(s)/PI(s)) from each HTAN recipient , i.e., from HTA Research Centers, PCA Research Centers, and the HTAN DCC; each Center will have one vote.

NIH/NCI Program staff members will participate in HTAN Steering Committee meetings as non-voting members but will provide final approval of HTAN policies.

If needed, other government staff members may also participate in HTAN Steering Committee meetings as non-voting members.

Two PD(s)/PI(s), representing two different HTAN awards, will be elected by the Steering Committee to serve as chairpersons starting at the first meeting of the Steering Committee following award 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 videoconference, and in-person at the HTAN biannual Steering Committee Meeting, and as needed.

The HTAN Steering Committee will be responsible for:

• Identifying scientific and policy issues that need to be, or can benefit by being, addressed at the Network level and develop recommendations to NIH/NCI Program Officials for addressing such issues.
• Ensuring progress of the HTAN toward meeting the overall Network goals.
• Ensuring that all HTAN members are utilizing the resources developed by the HTAN-DCC.
• Discussing and prioritizing the collaborative projects to be supported by the restricted "HTAN Pilot and Trans-Network Projects" funds within each Research Center.
• Coordinating, organizing, and disseminating Network output to the broader cancer research community, potentially including the organization of coordinated publications and/or presentations.
• Ensuring that the Network takes advantage of existing NCI and NIH resources and programs.
• Establishing, 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 NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS 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]

Shannon Hughes, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6224
Email: [email protected]

Sharmi Ghosh-Janjigian, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7122
Email: [email protected]

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

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6375
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.