Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title
3D Technologies to Accelerate HTAN Atlas Building Efforts (UH2 Clinical Trial Not Allowed)
Activity Code

UH2 Exploratory/Developmental Cooperative Agreement Phase I

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-CA-20-042
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393, 93.394, 93.395, 93.396, 93.399

Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) as a part of its Beau Biden Cancer Moonshot Initiative invites submission of applications requesting support for projects that will accelerate cancer research. Specifically, this FOA targets the following area designated as a scientific priority by the Blue Ribbon Panel (BRP) as Recommendation I: Generation of Human Tumor Atlases.

The overarching goal of this FOA is to accelerate research efforts conducted and led by the Human Tumor Atlas Network (HTAN, humantumoratlas.org) via the implementation of three-dimensional (3D) imaging technologies that will allow for a comprehensive view of the dynamic multidimensional ecosystems that define tumors in humans.

Each project will lead to the multiplexed 3D characterization of at least one cancer transition investigated by the HTAN (pre-malignant to malignant, primary to metastatic, therapy responsive to resistant). The data and analytical tools generated through this FOA will be made available for use by the research and clinical communities through the activities of the HTAN Data Coordinating Center.

Key Dates

Posted Date
June 25, 2020
Open Date (Earliest Submission Date)
October 09, 2020
Letter of Intent Due Date(s)

October 9, 2020

Application Due Date(s)

November 9, 2020

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

Expiration Date
November 10, 2020
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) as a part of its Beau Biden Cancer Moonshot Initiative invites submission of applications requesting support for projects that will accelerate cancer research. Specifically, the goal of this FOA is rapid implementation of promising new technologies into the Human Tumor Atlas Network (HTAN) to facilitate time-efficient, three-dimensional (3D) molecular characterizations of intact human tumor tissues. Successful applicants will apply their technologies to advance the HTAN mission of generating comprehensive human tumor atlases. A comprehensive human tumor atlas is defined as the multidimensional molecular, cellular, and morphological mapping of human cancers, complemented with critical spatial information (at the molecular, cellular, and/or tissue level) that facilitate visualization of the structure, composition, and multiscale interactions within the tumor ecosystem.

Background

Beau Biden Cancer Moonshot Initiative: NCI convened the Blue Ribbon Panel (BRP) in 2016 to provide recommendations for achieving the Cancer Moonshot's ambitious goal of making a decade's worth of progress in cancer prevention, diagnosis, and treatment in just 5 years, now called the Beau Biden Cancer Moonshot Initiative. The BRP was charged with assessing the state of the science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and in how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation for the Generation of Human Tumor Atlases (BRP Recommendation I). The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer Moonshot Initiative, including support for this FOA.

The Human Tumor Atlas Network (HTAN): Crucial transitions in cancer, including tumor initiation, metastasis, and therapeutic resistance, involve complex interactions betweenpre-malignant, malignant, and non-malignant cells, as well as extracellular components of the tumor ecosystem. Transformative single-cell and/or spatial genomics and proteomics methods now provide an opportunity to interrogate this complexity at unprecedented resolution. Aligned with BRP Recommendation I, The Human Tumor Atlas Network (HTAN) was established to harness these technologies for the development of longitudinal three-dimensional (3D) maps of human tumor evolution and intra-tumor heterogeneity. The HTAN currently includes five Human Tumor Atlas Research Centers (awarded under RFA-CA-17-034, five Pre-Cancer Atlas (PCA) Research Centers (awarded under RFA-CA-17-035), and an HTAN Data Coordinating Center (HTAN-DCC; awarded under RFA-CA-17-036) responsible for data storage, harmonization, distribution, and compilation of the final human tumor atlas collection. Tumor atlases are expected to advance the discovery of molecular markers of early detection, cancer progression, and therapy responsiveness. For more information, see the HTAN Website and the NCI HTAN Fact Sheet.

3D imaging: Spatio-molecular imaging techniques are a central component of ongoing HTAN efforts, surveying the expression of tens to thousands of genes across tumor tissues, often at single-cell resolution. However, their application is generally limited to two-dimensional (2D) analyses of thin tissue slices rather than intact tumor tissue. Reconstruction of 3D views consequently requires the acquisition of sequential, neighboring 2D tissue sections, which is time-consuming and may be destructive to the tissue architecture. The resulting 3D views may not accurately preserve spatial relationships, particularly irregular structures such as the tumor vasculature, extracellular matrix components, and heterogenous tumor tissue. Moreover, the detection of rare cell types can require large numbers of disconnected sections, causing image selection bias and the potential omission of key physiological landmarks. This poses a significant impediment to the BRP recommendation to create dynamic 3D tumor maps.

Research Objective and Main Requirements

In recent years, near single-cell resolution 3D technologies for the time-efficient, molecular mapping of protein, RNA, and other biomolecules in structurally intact tissues of mm3 volumes have advanced significantly, and several approaches that were unavailable at the time of the initial HTAN awards are now sufficiently developed to warrant integration within the network.

Through this FOA, the NCI invites cooperative agreement (UH2) applications from all Principal Investigators (PIs) with relevant expertise to apply near single-cell 3D imaging technologies to HTAN-relevant tumor tissues. Over the course of the award, non-HTAN grantees joining HTAN via this FOA are expected to apply their technology to HTAN-procured biospecimen, either by identifying collaborators within HTAN-funded research centers, or by leveraging shared tumor sources established as part of HTAN trans-network efforts. Research proposals may include initial plans to work with separately secured tumor specimen aligned with HTAN tumor types. Preference will be given to applications that investigate an HTAN-relevant cancer transition. See the HTAN Website and the NCI HTAN factsheet for a summary of tumor types and transitions investigated by the HTAN. Applicants are further encouraged to participate in HTAN trans-network projects meant to compare and harmonize data analysis and acquisition approaches using shared tumor tissue sources. Preliminary data demonstrating the use of the technology in a cancer context, including appropriate tissue preparation and data analysis capabilities, are required.

Successful efforts at multiplexed 3D characterizations of human tumor tissues will advance our understanding of intra- and inter-tumor heterogeneity by accurately preserving and characterizing spatial relationships that may help identify targetable cell-cell and cell-microenvironment interactions. Examples of suitable assay types include, but are not limited to: i) microscopy approaches that allow for the non-destructive imaging of mm3 biospecimen; and ii) sequencing approaches that infer relative cell positions based on biomolecule proximity in intact tissues. Analyses of components that could not satisfactorily be addressed using 2D imaging visualization, such as tumor vasculature, extracellular matrix components, and the detection of rare cell types, are of particular interest.

Applicants are encouraged to leverage, where feasible, technology from related NCI-sponsored informatics initiatives, for example, the NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research; the Innovative Molecular Analysis Technologies (IMAT) program, which supports the development, technical maturation, and dissemination of novel and potentially transformative next-generation technologies; or the NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact.

If applicable to the type of research being proposed, address how health disparity populations or data will be integrated into the proposed studies. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. In this context, efforts are encouraged to address the needs of racially/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates.

Coordination of the Human Tumor Atlas Network

Governance of the HTAN: All components of the HTAN, including individual UH2 awards, will be governed by the HTAN Steering Committee (see Section VI: Terms and Conditions of Cooperative Agreement). UH2 PDs/PIs must participate in monthly HTAN Steering Committee meetings and actively engage in HTAN activities, including but not limited to working groups and semi-annual face-to-face meetings. See the HTAN Website for a detailed description of HTAN organization and activities.

Evaluation of the Program: As the efficiency of the funded research is an important priority for NCI, all HTAN Research Centers, the HTAN DCC and individual UH2 awards will be expected to make themselves open to and fully cooperate with an external evaluation process of the HTAN coordinated by NCI program staff (see Section VI: Terms and Conditions of Cooperative Agreement).

Cancer Moonshot Public Access and Data Sharing Policy

Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer Moonshot Initiative that requires applicants to submit a Public Access and Data Sharing Plan that: (1) describes their proposed process for making resulting publications and to the extent possible, the Underlying Primary Data immediately and broadly available to the public upon publication; and (2) if applicable, provides a justification to NCI if such sharing is not possible. NCI will give competitive preference and funding priority to applications that comply with the strategy described here. To comply with these mandates, HTAN has established a comprehensive data sharing and management agreement (https://humantumoratlas.org/resources/), which, together with the NCI Cancer Moonshot Public Access and Data Sharing Policy, will become term and condition of the award. Data and computational tool sharing by HTAN members will follow Findable, Accessible, Interoperable, and Reusable (FAIR) principles. All data, protocols, and standard operating procedures for multi-parameter data collection, and, preferably, open-source analysis workflows must be deposited with the HTAN DCC and made available to the network following appropriate quality control.

Non-responsive Applications

The following types of analyses are outside the scope of this FOA and applications describing them be considered non-responsive:

  • Imaging approaches that do not provide near single-cell resolution.
  • Projects proposing early-stage exploratory development of new technologies and approaches that are not ready for immediate implementation and adoption.
  • Analyses of non-HTAN relevant tumor types.
  • 3D image reconstruction from 2D image analyses of serial tumor tissue sections.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI intends to commit $1.75 M in FY 2021 to fund four awards.

Award Budget

Application budgets are limited to $250,000 in direct cost per year and must reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 2 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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 Governments

  • 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
Foreign Institutions

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

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

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

Required Registrations

Applicant organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

 

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

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 FOA. 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 SF424 (R&R) Application Guideexcept where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

 

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

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

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

The letter of intent should be sent to:

Philipp Oberdoerffer, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-760-6681
Email: Philipp.Oberdoerffer@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

 

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

PIs must budget for travel to HTAN semi-annual face-to-face meetings and applicable open access publication fees. Applicants are strongly encouraged to identify an HTAN collaborator to align tissue procurement with HTAN objectives. A budget for tissue sourcing must be included.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Significance:

  • Describe how the proposed 3D imaging approach captures high-resolution tumor architecture and spatial distribution of target analytes that might enhance our understanding of mechanisms underlying cancer progression and/or treatment decisions for cancer patients.
  • Describe how the proposed research improves time efficiency and throughput of molecular characterizations of large (mm3) tumor biopsies.

Approach:

  • Provide a rationale for the molecular markers that will be assayed with the 3D imaging approach.
  • Demonstrate the feasibility of the 3D imaging assay(s) in HTAN-relevant tumor specimens, and describe how the proposed 3D analyses integrate with and complement existing HTAN atlas building efforts (see the HTAN Website and the NCI HTAN factsheet).
  • Describe how the 3D technology improves time-efficiency of the molecular characterization of large tumor volumes.
  • Demonstrate capability to analyze the resulting complex data sets.
  • Applicants are expected to identify an HTAN collaborator to align tissue sourcing with HTAN objectives. In the absence of an identified HTAN collaborator, applicants are required to describe tissue procurement and how it aligns with current HTAN tumors.

Milestones and Timeline:

Define a clear set of tentative semi-annual milestones with metrics that will document progress towards the proposed research goal. Scientifically justified and, where appropriate, quantitative milestones are required to provide clear indicators of the project's continued success or emergent difficulties. Milestones will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years.

Milestones and timeline must be provided in a separate heading at the end of the Approach section and should:

  • Provide appropriately detailed (quantitative) criteria by which milestone achievement will be assessed.
  • Provide a detailed timeline for the anticipated attainment of each milestone and the overall goal.
  • Identify any impediments that could significantly impact the research plan, milestones, or timeline with a discussion of alternative approaches.

If applicable to the type of research being proposed, address how health disparity populations or data will be integrated into the proposed studies. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. In this context, efforts are encouraged to address the needs of racially/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates.

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.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, are expected to adhere to the HTAN Data and Materials Sharing Agreement (https://humantumoratlas.org/resources/) and the NCI Cancer Moonshot Public Access and Data Sharing Policy.

  • Applicants should consider pre-existing intellectual property rights associated with the use of existing models/technologies/biospecimens. If proprietary tools/devices are used, applicants should clearly describe such tools/devices along with any related licensing agreement and are advised to contact NCI and seek assistance as needed from the NCI Technology Transfer Center in determining whether such arrangements are appropriate and/or adequate.

Addressing the Cancer Moonshot Open Access Pilot Program: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer Moonshot Initiative that requires applicants to submit a Public Access and Data Sharing Plan that: (1) describes their proposed process for making resulting publications and to the extent possible, the underlying primary data immediately and broadly available to the public upon publication; and (2) if applicable, provides a justification to NCI if such sharing is not possible. NCI will give competitive preference and funding priority to applications that comply with the above policy. The data sharing plan will become a term and condition of award.

Appendix:

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

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-definedclinical 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.

PHS Assignment Request Form

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

4. Submission Dates and Times

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 Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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 NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

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.

 

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 FOA

To what degree does the proposed 3D imaging approach capture high resolution tumor architecture and spatial distribution of target analytes that might enhance our understanding of mechanisms underlying cancer progression and/or treatment decision for cancer patients? How well does the project propose to characterize samples spanning a cancer transition investigated by the HTAN?

 

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?

 

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?

 

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?

Specific to this FOA

How clearly have the applicants defined the HTAN tumor type and preferably a cancer transition investigated by the HTAN as the subject of their proposed research? How well do the preliminary data demonstrate the capabilities for their proposed 3D imaging approach in a tumor type investigated by the HTAN? How well do the proposed 3D analyses integrate with and complement existing HTAN atlas building efforts? How well does the proposed research improve the time efficiency and throughput of molecular characterizations of large (mm3) tumor biopsies? How sufficient are the milestones to ensure successful 3D characterization of an HTAN-relevant cancer transition? How adequate are the investigators' plans presented to include a population representative of the diverse population of the United States?

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?

 

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.

How well does the application provide a plan for sharing data in accordance with the NCI Cancer Moonshot Public Access and Data Sharing requirements?

 

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

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

 

When the proposed 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.

 

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

 

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

 

Not Applicable

 

Not Applicable

 

Not Applicable

Additional Review Considerations

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.

 

Not Applicable

 

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

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS), and (4) the NCI Cancer Moonshot Public Access and Data Sharing requirements.

 

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

 

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

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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.
  • Compliance with the Cancer Moonshot Open Access and Data Sharing Policy
  • Compliance with the HTAN Publication Policy, the HTAN Protocol and Computational Tool Sharing Policy, the HTAN External Data Sharing Policy and the HTAN Data and Materials Sharing Agreement (https://humantumoratlas.org/resources/).

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 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 grantee’s business official.

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

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

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

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 FOA.

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 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), and other HHS, PHS, and NIH grant administration policies.

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

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

  • Overseeing the scientific research in the Research Project, 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 award a minimum of 1.2 person-months of effort per year for the investigator designated as the Contact PD/PI.
  • Agreeing to be an active participant in the HTAN, including attending the semi-annual in-person meetings and the monthly virtual Steering Committee Meeting, participating in other network-sponsored meetings and workshops, and participating in collaborative activities.
  • Serving on the HTAN Steering Committee. The PD/PI (Contact PD/PI for applications with multiple PD(s)/PI(s)) is required to serve as a voting member 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.
  • Leveraging, where feasible, technology from related NCI-sponsored informatics initiatives, for example the NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research, or the Innovative Molecular Analysis Technologies (IMAT) program, which supports the development, technical maturation, and dissemination of novel and potentially transformative next-generation technologies.
  • Coordinating with and leveraging, where feasible, the technology of the NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact.
  • Ensuring that data are deposited in a timely manner to the HTAN Data Coordinating Center, and that models, software, and other tools and resources developed as part of this award are made publicly available according to HTAN data sharing policies (https://humantumoratlas.org/resources/) and in accordance with the Cancer Moonshot Public Access and Data Sharing Policy. Additionally, all HTAN members will be required to utilize the resources within the HTAN Data Coordinating Center, including common data elements and metadata dictionaries developed in collaboration with HTAN investigators.
  • Ensuring that results are published in a timely manner.
  • Organizing scientific working groups to facilitate collaborative projects and cross-testing of experimental and analytical concepts.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NCI staff 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 involvement as Project Scientist(s) for the HTAN.

In carrying out its stewardship of Cancer Moonshot initiatives, the NCI will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act.

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 Data Coordinating Center (RFA-CA-17-036), individual Human Tumor Atlas (RFA-CA-17-034) and PreCancer Atlas (RFA-CA-17-035) Research Centers, and UH2 (this FOA) awardees in avoiding unwarranted duplications of effort across the HTAN.
  • Facilitating collaborative research efforts that involve multiple HTAN Research Centers.
  • Assisting the awardees as a resource 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 Data Coordinating Center data- and tool-sharing infrastructure is provided to HTAN members including UH2 awardees in a reasonable and expeditious way.
  • Evaluating the effectiveness and facilitating 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 UH2 funds.
  • Reviewing the progress of the HTAN awardees (including HTAN Data Coordinating Center), conducting periodic site visits, and taking other actions as needed.
  • Participating in organizing semi-annual HTAN meetings, specialized workshops, and webinars of the Network.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

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 one representative (contact PD/PI or other senior level investigator) from each HTAN awardee, i.e., from Human Tumor Atlas Research Centers, PreCancer Atlas Research Centers, the HTAN Data Coordinating Center, and UH2 awards, who will have one vote each.

NIH/NCI program staff members will participate in HTAN Steering Committee meetings as non-voting members.

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

Three PD(s)/PI(s), representing three different HTAN awards, are elected to serve as chairpersons of the Steering Committee. Chairpersons serve 2-year terms. All HTAN Steering Committee decisions and recommendations that require voting will be based on a majority vote.

The HTAN Steering Committee will meet monthly by videoconference, in-person at the HTAN semi-annual Steering Committee Meeting and as needed.

The HTAN Steering Committee will:

  • Identify scientific and policy issues that need to be, or can benefit by being, addressed at the Network level and develop recommendations to NIH/NCI Program Officials for addressing such issues.
  • Review progress of the HTAN toward meeting the overall Network goals.
  • Ensure that all HTAN members utilize the resources developed by the HTAN-DCC.
  • Discuss and prioritize the collaborative projects to be supported by the restricted "HTAN Collaborative Project" funds within each Research Center.
  • Coordinate dissemination of Network output to the broader cancer research community.
  • Ensure that the Network takes advantage of existing NCI and NIH resources and programs.
  • Establish, as necessary, subcommittees to ensure progress of the individual Centers and the Network.

Dispute Resolution:

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

3. Reporting

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

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

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

Application Submission Contacts

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

Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov

Scientific/Research Contact(s)

Philipp Oberdoerffer, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-760-6681
Email: Philipp.Oberdoerffer@nih.gov

Shannon Hughes, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6224
Email: Shannon.Hughes@nih.gov

Tracy Lively, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5944
Email: livelyt@mail.nih.gov

Sudhir Srivastava, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-7028
Email: srivasts@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.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.

Authority and Regulations

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.


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