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 non-competitive Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits an application to fund a single award to the Dana Farber Cancer Institute for a Human Tumor Atlas Network (HTAN) Data Coordinating Center (DCC). The HTAN-DCC will have three major areas of responsibility: (1) Data Standards, Storage, and Dissemination; (2) Consortium Coordination; and (3) Community Outreach. The HTAN-DCC will collect, store, curate, and disseminate all data, metadata, analysis and visualization tools, computational models, and completed atlases generated by the HTAN. Additionally, the DCC will lead the development and implementation of common data elements, data and metadata standards, clinical and epidemiological data requirements, and data processing pipelines. The DCC will also coordinate HTAN activities including in-person and virtual Network Steering Committee meetings and working groups. Finally, the HTAN-DCC will promote collaboration and communication between HTAN Investigators and the broader research community and coordinate the Network outreach activities.
The HTAN-DCC will be part of the Human Tumor Atlas Network (HTAN), which will also include HTA Research Centers (solicited under RFA-CA-23-039) and PreCancer Atlas (PCA) Research Centers (solicited under RFA-CA-23-040).

Rationale for Single Source

The current HTAN-DCC serves as an essential component of the HTAN program. The DCC is led by a multi-PI team from Dana Farber Cancer Institute, Sage Bionetworks, Memorial Sloan Kettering, and the Institute for Systems Biology. The DCC has been in place since 2018 and has performed admirably in developing and implementing data ingestion pipelines, leading data and metadata standards development, ingesting and sharing data, and working closely with the NCI Cancer Research Data Commons (CRDC) to facilitate sharing of controlled access data and long-term data sustainability.

To date, the DCC has developed and implemented data standards and metadata requirements for 16 distinct assay types along with establishing clinical and biospecimen data standards. The DCC has worked closely with HTAN investigators to ingest and share more than 80TB of harmonized data across nearly 4000 biospecimens. The DCC has also implemented several data visualization tools to support viewing and interacting with both genomics and imaging datasets. These include the cellXgene visualization tool for viewing single-cell sequencing data and the AutoMinerva tool for visualization highly multiplexed imaging data. The HTAN-DCC team has also worked over the last several years to develop a close working relationship with the NCI CRDC teams which is essential to both sharing of controlled access data and to support the long-term availability of HTAN datasets through NCI data infrastructure.

While the NCI recognizes and endorses the need for full and open competition, and by preference utilizes open competition in the vast majority of its initiatives, we believe that the investments made by the NIH and the proven effectiveness of the HTAN-DCC warrants an exception. Transferring the extensive data collection, reimplementing the data models, developing and implementing new visualization tools, and establishing new working relationships would incur a substantial time and financial cost. Therefore, a Single Source NOFO, which is open only to the Dana Farber Cancer Institute, is issued for the HTAN-DCC. The requested project would cover the same core elements of responsibility: (1) Data Standards, Storage, and Dissemination; (2) Consortium Coordination; and (3) Community Outreach.

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, multi-dimensional 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 that have the potential to impact cancer diagnosis, as well as inform the development of interception and treatment strategies. The HTAN has generated valuable resources for the community that include data and metadata standards, experimental protocols, analytical methods underlying the HTAN atlases, and open access publications. HTAN resources can be accessed at https://data.humantumoratlas.org/. More information regarding available HTAN atlases, datasets, protocols, and analytical tools can be found at www.humantumoratlas.org.

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

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 normal 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.

Research Objectives and Main Requirements

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.

The HTAN will support two types of atlas-building initiatives, please see each NOFO for additional details about atlas development:

• 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.

The atlas-building initiatives will be supported by the HTAN-DCC (this NOFO) which will be responsible for: (1) Data Standards, Storage, and Dissemination; (2) Consortium Coordination; and (3) Community Outreach.

Objective of the HTAN Data Coordinating Center

The overarching mission of the HTAN-DCC will be to collect, store, curate, and disseminate all data, metadata, experimental protocols and standard operating procedures, and analysis and visualization tools generated by the HTAN. Additionally, the DCC will lead the development and implementation of common data elements, data and metadata standards, clinical and epidemiological data requirements, and data processing pipelines. The DCC will also coordinate HTAN activities including in-person and virtual HTAN Steering Committee meetings, subcommittees, and working groups. Finally, the HTAN-DCC will promote collaboration and communication between HTAN investigators and the broader research community and coordinate Network outreach activities. The HTAN-DCC, HTAN investigators, and NCI staff will need to work closely together to accomplish the goals of the HTAN-DCC in a manner that will best benefit all HTAN investigators and the broader scientific community.

Specific activities and roles of the HTAN-DCC will include, but are not limited to:

Data Standards, Storage, Analysis, and Dissemination

• Developing and upgrading an HTAN Data Portal for user-friendly submission of and access to HTAN data (both raw data and derived datasets), metadata, experimental protocols and standard operating procedures, and analysis and visualization tools, generated by the HTAN.
• Establishing and maintaining a back-end database with an application framework to facilitate complex data loading including detailed experimental descriptions and metadata. The database should be flexible and extensible to manage and integrate all data types generated by HTAN Research Centers. The database will also need to incorporate dynamic 3D spatial data.
• Working closely with HTAN investigators and NCI staff through HTAN subcommittees and working groups to establish common data elements, data standards, metadata requirements, clinical and epidemiological data requirements, and controlled vocabularies for all HTAN data to ensure that the data are findable accessible, interoperable, and reusable (FAIR).
• Working closely with HTAN investigators and the NCI Cancer Research Data Commons (CRDC) team to develop and implement common data submission, processing, harmonization, and quality control pipelines for the diverse range of HTAN datasets.
• Working closely with HTAN investigators to reprocess HTAN datasets using common pipelines to facilitate integrative and pan-cancer analyses and data reuse.
• Working closely with HTAN investigators to implement data analysis and visualization tools at the HTAN Data Portal and the CRDC Cloud Resources to facilitate utilization and exploration of HTAN atlases by the broader research community.
• Participating in monthly CRDC-DCC meetings and annual NCI CRDC Symposia to ensure interoperability between CRDC and HTAN-DCC resources and long term resource and data storage options.
• Working closely with the CRDC team and NCI staff to deposit all HTAN data types, data levels, and derived datasets to NCI data resources to ensure the long-term availability beyond the HTAN funding period.

Consortium Coordination

• Working closely with HTAN Investigators and NCI staff to ensure that all data, protocols, biospecimen and reagent information, analysis and visualization tools, and atlas datasets generated or developed by HTAN Investigators are deposited in a timely manner and made accessible through the HTAN Data Portal consistent with NIH, NCI, and HTAN data sharing policies.
• Providing the administrative infrastructure necessary to facilitate and coordinate all common activities of the HTAN.
• Working with NCI staff to organize HTAN scientific meetings, including an HTAN Kickoff Meeting and semi-annual 2-3 day in-person HTAN Steering Committee Meetings.
• Working with NCI staff to organize and coordinate HTAN governing and advisory bodies including the HTAN Steering Committee and subcommittees, HTAN working groups, and external scientific consultants. Managing these activities by organizing web-based conferences, taking and publishing meeting minutes, and drafting reports for the various committees, working groups, and panels. Developing and making accessible all significant HTAN-related documents, including policies, reports, and standard operating procedures generated by the various HTAN committees.
• Facilitating other HTAN activities, including but not limited to: organizing small topical workshops; implementation of HTAN developed policies; and facilitating consortium opinion and perspective pieces.

Community Outreach

• Developing and maintaining a main HTAN Data Portal that will constitute the main entry point for the sharing of resources and information related to HTAN activities. Develop and implement user-friendly approaches to navigate and access resources generated by the HTAN, including protocols, data standards, biospecimen and reagent information, tutorials, analysis and visualization tools, and atlas datasets. 
• Developing and sharing tutorials, detailed walkthroughs, and other materials that facilitate use of HTAN-generated data, analysis and visualization tools, and completed atlas datasets by the broader scientific community.
• Hosting webinars, workshops, hackathons, and other events to showcase the availability of HTAN data and resources and provide guidance and how to use HTAN data and resources.
• Facilitating interactions with other NCI and NIH supported efforts, and/or non-NIH partners. These may include consortia, bio-repositories, databases, or non-profit organizations involved in activities relevant to the mission of the HTAN. The focus should be on developing interactions that can benefit both investigators and partners of the HTAN through the sharing of information, expertise, and reagents, or through leveraging the coordination of research and technology development in areas of common interest.
• Managing or facilitating other outreach activities, including but not limited to, organizing sessions and tutorials at scientific meetings and managing the HTAN social media presence.
• Evaluating the impact of outreach activities through tracking of data use and download.

Development of the HTAN-DCC will require the DCC team to work closely with all components of the HTAN, including funded investigators and NCI staff, to establish data and metadata standards, develop data submission and processing pipelines, establish data freezes and public release of data, and coordinate data integration and analysis. We anticipate that most datasets handled by the DCC will be spatial proteomics and transcriptomics data, single-cell and bulk sequencing data, proteomics and metabolomics data, pathology and clinical imaging, and epidemiological and clinical data. However, it is difficult to predict the exact volume and types of data that will be submitted over the lifetime of the HTAN Program. Increasing efficiencies in generating data along with potential changes in technology platforms may dramatically alter the types and volume of data to be stored, curated, and processed by the HTAN-DCC. Additionally, HTAN data will likely be generated across many disease types and cancer-relevant transitions, adding another layer of complexity to the curation and mining of the data. HTAN-DCC should demonstrate the expertise and flexibility to accommodate increasing data volume and evolving data types.

The HTAN-DCC is also expected to evolve, adapt, and improve during the project in response to the needs of the HTAN community. The DCC team should solicit user feedback and otherwise evaluate all aspects of the usability of the HTAN Web Portal and Data Portal to best serve the needs of the HTAN and broader research community. As the data generation, storage, analysis, and dissemination needs of the HTAN evolve over time, the DCC may be asked to implement modifications to its workflows as agreed upon by the HTAN investigators and NCI staff. The DCC should be flexible in their implementation of data coordination, analysis, and outreach workflows.

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 projects are outside the scope of this NOFO and will be considered non-responsive. (Non-responsive applications will not be reviewed.)

• Projects that do not address all sub-sections described in the Research Strategy instructions (see Section IV.2: Content and Form of Application Submission - PHS 398 Research Plan).

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

Only the following applicant may apply for this single source funding: the Dana Farber Cancer Institute.

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.

Only the PI/PDs associated with the award issued under RFA-CA- 17-036 to the Dana Farber Cancer Institute is eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details. 

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

Only the PI/PDs associated with the award issued under RFA-CA- 17-036 to the Dana Farber Cancer Institute is eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

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).

• Only a single award will be issued to the Dana Farber Cancer Institute under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details. 
• An investigator designated as the Contact PD/PI of an application under this NOFO must not be the designated Contact PD/PI of an application under the companion HTAN NOFOs RFA-CA-23-039 and RFA-CA-23-040.

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:

Sean E. Hanlon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3310
Email: sean.hanlon@nih.gov

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

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

In addition, applicants should:

• Demonstrate strong scientific expertise in the areas that are critical to the success of the application.
• Describe any experience in successfully leading the coordination of large complex consortia and managing data intensive activities such as those conducted by the HTAN.

R&R Budget

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

Leadership Effort Commitment: For single PD/PI applications, a minimum of 1.8 person-months 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-months of their time per year to the award. Commitment cannot be reduced in later years of the award below the levels stated above.

HTAN-DCC Administrator: Based on the complexity of the HTAN-DCC, the DCC PD(s)/PI(s) are required to propose and budget for an HTAN-DCC Administrator to manage day-to-day operations and work with the DCC PD(s)/PI(s), NCI staff, and HTAN Investigators to manage and coordinate the DCC activities.

HTAN Trans-Network Projects: Although not required, applicants may set aside up to 10% (Direct Cost) of their annual budget in Years 2-5 that will be used for HTAN-DCC participation in approved HTAN trans-network projects. Specific trans-network projects should not be specified within the application.

Travel Funds: The budget should include funds to support travel for HTAN activities, including but not limited to supporting the travel and participation of PD(s)/PI(s) and other HTAN-DCC members at the semi-annual HTAN Steering Committee meeting and annual site visits.

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: Specific Aims should address the four subsections described below (DCC Vision and Management; Data Standards, Storage, Analysis, and Dissemination; Consortium Coordination; and Community Outreach).

Research Strategy: In lieu of the standard sub-sections listed in the SF424 (R&R) Application Guide, the Research Strategy must consist of the following modified sub-sections.

Sub-Section A: DCC Vision and Management

Overview and Goals – Applicants should describe the ultimate goals/deliverables of the HTAN-DCC. Deliverables should be quantitative whenever possible and would include items such as:

• Maintain and further develop the HTAN Data Portal;
• Establish network-wide consensus for data formats and metadata requirements;
• Establish network-wide consensus for a data release policy;
• Develop and implement data submission, processing, harmonization, quality control assessment, and download pipelines;
• Implement common data processing pipelines across all HTAN data;
• Establish semi-annual in-person HTAN Steering Committee meetings;
• Implement analysis and visualization tools developed by HTAN Investigators at the HTAN Data Portal and at the CRDC Cloud Resources;
• Develop user manuals and tutorials for the HTAN Data Portal; and
• Lead outreach activities to promote use of HTAN resources.

As mentioned above, it will be difficult to predict the exact volume and types of data that will be submitted over the lifetime of the HTAN Program. As the data production, storage, analysis, and dissemination needs of the HTAN change with time, the HTAN-DCC may be asked to implement modifications to their workflow and deliverables and applicants must demonstrate their willingness and aptitude to be flexible in their implementation of HTAN coordination.

Previous accomplishments of the HTAN-DCC – Applicants should describe their previous activities related to data and program coordination within the HTAN program. Applicants should provide an overview of the previous HTAN-DCC structure and function and describe, at a high-level, any high-level changes that are planned for the next phase of the program based upon previous successes or challenges. Applicants should describe any new challenges they anticipate may impact the HTAN-DCC in the second phase of the program and describe how they will be overcome.

Management and Communication Plan – Applicants should describe the plans for management and integration of the HTAN-DCC activities. Applicants should describe how it will manage the proposed project, who will oversee the day-to-day activities (e.g., a DCC Administrator if not the PD/PI) and how the management structure will support achievement of the proposed goals and milestones. Useful elements of this description include the organization of the proposed project; its management structure; key personnel and leadership structure; and oversight mechanisms for evaluating progress towards milestones. Applicants should describe plans for ongoing communication within the HTAN-DCC and between the DCC and other components of the HTAN. Plans for addressing some of the anticipated challenges of the DCC should also be included. The plan should also describe how the various elements of the proposed production effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.

Sub-Section B: Data Standards, Storage, Analysis, and Dissemination

Data Portal Development – Applicants should describe plans for maintaining and improving the HTAN Data Portal. The HTAN Data Portal should provide access to both HTAN members and the broader scientific community. Applicants should describe a submission pipeline for both raw and derived datasets generated by HTAN Investigators. Each submitted dataset must be assigned a unique identifier that enables subsequent tracking for submitted data of all types. This pipeline must include quality assurance steps to monitor the quality of the submitted data and metadata, along with steps to release these data and metadata to the public data portal in a timely fashion. As the identity of the actual funded projects will not be known at the time that the applications in response to this NOFO are due, applicants should provide a general submission plan. It is anticipated that most datasets handled by the DCC will be spatial proteomics and transcriptomics data, single-cell and bulk sequencing data, proteomics and metabolomics data, pathology and clinical imaging, and epidemiological and clinical data. The plan should describe how the DCC will handle a range of data types and how the DCC will provide the flexibility to accommodate increasing data volume and evolving data types. The plan should describe the capacity to scale activities as data volumes or complexity change over the course of the project. Applicants should describe plans to work the NCI Cancer Research Data Commons (CRDC) throughout the project to deposit all HTAN data types, data levels, and derived datasets in NCI resources. By the end of the project, all HTAN data must be transferred to the CRDC.

Data Storage and Access – The HTAN DCC is responsible for housing all data generated by the HTAN. It is expected that the HTAN DCC will host and share all HTAN data within the network (both controlled and open access data), the HTAN DCC will only distribute open access data to the public. The HTAN DCC will be responsible for submitting any controlled access data generated by HTAN to the appropriate repository (e.g., the Cancer Data Service, the Genomic Data Commons, dbGaP) for distribution to the public through the NCI CRDC Cloud Resources. The data storage plan should describe a system that can distinguish between and segregate controlled-access and open-access data. The plan should also describe how all HTAN data will be made available to members of the HTAN network in an expedited pre-publication fashion to facilitate timely launch and completion of HTAN trans-network and pilot projects.

Information Technology and Technology Development – Applicants should discuss all pertinent informatics issues involved in providing the basic IT infrastructure/system administration for the proposed project. The plan should describe the existing framework that facilitates complex data loading including detailed experimental descriptions and metadata. The database infrastructure should be flexible and extensible to manage and integrate multiple types of data that may be generated by HTAN investigators, including spatial proteomics and transcriptomics data, single-cell and bulk sequencing data, proteomics and metabolomics data, pathology and clinical imaging, and epidemiological and clinical data. Incremental technology improvements may play an important role in increasing the efficiency and decreasing costs for the DCC. Applicants are encouraged to include plans for such technology development activities in their applications, such as supporting new software tools to improve data management or making existing software more efficient. The plans for technology improvement should be well described and the cost of the proposed technology development should be justified in terms of reducing the overall operating costs for the DCC.

Interactions with HTAN Data Producers – Development of the HTAN-DCC will require the DCC team to work closely with HTAN investigators and NCI staff. Applicants should describe plans and strategies for facilitating interactions that allow the efficient development of the DCC. DCC tasks that will require significant interaction with other members of the HTAN program include, but are not limited to:

• Work with HTAN investigators and NCI staff to establish standardized machine readable data formats and common data elements using well-defined formats and associated controlled vocabularies.
• Work with HTAN investigators and NCI staff to define standard experimental metadata, epidemiological data, and clinical data required to be submitted with each dataset.
• Work with HTAN investigators to develop and implement data submission, processing, harmonization, and quality control pipelines for all data types that will be submitted to the DCC.
• Work with HTAN investigators to facilitate the timely and efficient transfer of data, metadata, and completed atlas datasets to the DCC and the NCI CRDC resources.
• Work with HTAN investigators and NCI staff to establish regular data freezes and releases to quantify productivity and facilitate analysis activities.
• Work with HTAN investigators and the NCI CRDC to ensure only de-identified HTAN data is being submitted and shared.
• Work with HTAN investigators and NCI staff to establish a public data release policy. The DCC will need to be flexible and responsive in following the evolving NIH policies on data sharing.
• Work with HTAN investigators and NCI CRDC staff to develop outreach and training materials to promote the reuse of HTAN data and resources.

Data Wrangling – The DCC must provide mechanisms and staff to interact with the data production groups to facilitate the timely and efficient transfer of data, metadata, and completed atlas datasets to the DCC. Applicants should describe plans for working closely with HTAN investigators and NCI staff to ensure that all data and metadata, protocols, biospecimen and reagent information, analysis and visualization tools, and completed atlas datasets generated or developed by HTAN Investigators are deposited in a timely manner and made accessible through the HTAN Data Portal consistent with NIH, NCI and HTAN sharing policies.

Implementation of Analysis and Visualization Tools – Applicants should describe plans to implement analysis and visualization tools developed by HTAN Investigators at the HTAN Data Portal and the Cancer Research Data Commons Cloud Resources. Priority should be given to tools and software that are modular, open-source, include appropriate documentation, use standard formats for data input and output, and are considered likely to be broadly useful to the research community.

Data Export and Dissemination – Applicants should describe plans for developing an export process and pipeline to permit timely transfer of HTAN data to appropriate public repositories and community databases to ensure the long-term availability of HTAN generated data. These repositories may include, but are not limited to, the NCI Cancer Data Service (CDS), the NCI Genomic Data Commons (GDC), and the database of Genotypes and Phenotypes (dbGAP) at the National Center for Biotechnology Information (NCBI). Regardless of where datasets are deposited, the HTAN-DCC will facilitate user-friendly access to the open access HTAN-generated data and metadata for the duration of the Program. Data and metadata must be available in standard formats and adhere to the FAIR (findable, accessible, interoperable, and reusable) principles to ensure the data and results are maximally useful to members of HTAN and the broader scientific community.

Sub-Section C: Network Coordination

HTAN Policy Implementation – Applicants should describe plans to work closely with HTAN investigators and NCI staff to ensure that all data, protocols, biospecimen and reagent information, analysis and visualization tools, and completed atlas datasets generated or developed by HTAN Investigators are deposited in a timely manner and made accessible through the HTAN Data Portal and/or NIH/NCI repositories in a manner consistent with HTAN data, tools, and protocol sharing policies. Additionally, applicants should describe plans to identify incomplete data submissions.

HTAN Activity Coordination – Applicants should describe an approach to provide the administrative infrastructure necessary to facilitate and coordinate all common activities of the HTAN. HTAN activities that will be coordinated by the HTAN-DCC will include: semi-annual 2-3 day HTAN in-person Steering Committee Meetings and focused workshops, monthly HTAN virtual Steering Committee and subcommittees, virtual HTAN working groups, and external scientific panels. The plan should describe approaches for managing these activities through in-person or web-based meetings, taking and publishing meeting minutes, and drafting reports for the various committees and working groups. Additionally, the plan should describe an approach to develop, maintain, and make accessible all significant HTAN-related documents, including policies, reports, and standard operating procedures generated by the various HTAN committees, working groups, and panels. The plan should also include approaches to facilitate interactions and collaborations with outside groups, other NCI and NIH supported efforts, and/or non-NIH partners.

Sub-Section D: Community Outreach

Data Portal User Experience Testing: Applicants should provide plans to evaluate the user experience (UX) of the HTAN Data Portal. Plans should address the frequency of UX studies and how results of the studies will be shared with the HTAN community and used to improve the HTAN Data Portal.

Outreach, Documentation and User Support – Applicants should describe a plan and allocate sufficient resources to provide outreach to the user communities to educate the community about the HTAN and its data, resources, tools, and completed atlases. This plan should include resources for both specialists and non-specialists to make the best use of the HTAN data, computational models, tools, and completed atlas datasets. Examples include presentations, short courses, or symposia offered independently or in conjunction with scientific meetings attended by the user community. Provide plans to develop and update HTAN DCC user documentation to be made available on the HTAN Data Portal such as User’s guides, FAQs, Troubleshooting Tips, web-based tutorials and other content to assist HTAN DCC data consumers, data providers, and general users.

HTAN Resource User Support – Applicants should describe typical user support activities to be performed by the HTAN DCC staff including, but not limited to, receiving and addressing user inquires, providing email support, maintaining publicly accessible website for helpdesk operations, providing news and announcements, hosting application use reports, frequently asked questions and troubleshooting tips, and providing summary reports of questions and responses, including frequency of inquiries and duration between inquiry and resolution as appropriate.

HTAN Resource Training – Applicants should describe plans to offer hands-on training opportunities to explore HTAN resources. These may include HTAN Hackathons, Data Jamborees, and Tutorials that provide the broader research community the opportunity and training to utilize HTAN data and resources. Plans to evaluate the impact of the resource training activities should be described.

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 the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

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 proposed Data Coordinating Center address the needs of the research Network that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research Network? 

Specific to this NOFO: What is the likelihood that DCC, as proposed, will meet all the data management, consortium coordination, and outreach needs of the HTAN? How well will the proposed DCC be able to meaningfully contribute to HTAN, e.g., by resolving major challenges in data management, consortium coordination, and outreach?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Data Coordinating Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary research? Do the investigators demonstrate significant experience with coordinating collaborative large-scale omics and imaging-based research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, management plans, governance, plans for conflict resolution, and organizational structure appropriate for the Data Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this NOFO: How well do the PD(s)/PI(s) demonstrate evidence of experience working productively in collaborative environments and in large, distributed scientific projects?   

Innovation

Does the application propose novel data management, network coordination, and outreach strategies in coordinating the research Network the Data Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of data management, network coordination, and outreach strategies proposed?

Approach

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?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research Network the Data Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this NOFO: How well does the research plan address the HTAN-DCC's three major areas of responsibilities (1) Data Storage, Dissemination, Analysis, and Visualization; (2) Consortium Coordination; and (3) Community Outreach?

Environment

Will the institutional environment in which the Data Coordinating Center will operate contribute to the probability of success in facilitating the research Network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Data Coordinating Center proposed? Will the Data Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this NOFO: How adequate is the computational infrastructure to meet the needs of the project? How well does the environment promote the collaborations, transdisciplinary approaches, and flexibility required to solve the technical and scientific problems of the proposed HTAN-DCC?

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For Networks 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 National Cancer Institute (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.

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 development and management of the HTAN-DCC, reporting results to the scientific community, and disseminating data, approaches, methods, models, software, and tools broadly.
• Committing and maintaining throughout the life of the HTAN-DCC 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 HTAN-DCC 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 HTAN-DCC 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 HTAN-DCC 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 HTAN-DCC 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.
• Working closely with HTAN data generators to ensure that data, metadata, models, software, and completed atlases developed by the HTAN are deposited in the HTAN Data Portal and publicly released in a timely manner that is consistent with 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.
• Maintaining the confidentiality of the information developed or handled by the HTAN-DCC, including, but not limited to: unpublished data, informatics tools, protocols, data analysis, confidential exchanges between members of the HTAN, etc.
• 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-DCC personnel participate in atlas-related events, special interest groups, and/or working groups that promote collaboration and resource sharing across atlas efforts.

Recipients 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 HTAN-DCC 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 recipients in avoiding unwarranted duplications of effort across the HTAN.
• Facilitating collaborative research efforts that involve multiple HTAN Research Teams and would be suitable for consideration as a trans-HTAN collaborative project to be funded by restricted funds.
• Assisting the recipients 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 recipients and making recommendations on overall project directions and allocations of HTAN-DCC and HTAN Research Center funds.
• Reviewing the progress of the HTAN recipients (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 on matters 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 subcommittee 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 subcommittee 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: GrantsInfo@nih.gov (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: support@grants.gov

Sean E. Hanlon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3310
Email: sean.hanlon@nih.gov

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

Amy Bartosch 
National Cancer Institute (NCI)
Telephone: 240-276-6375
Email: amy.bartosch@nih.gov 

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.