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

Revision Applications to National Cancer Institute (NCI)-supported P01 Awards to Include Research on the NCI's Provocative Questions (P01)

Activity Code

 P01 Research Program Projects

Announcement Type

Reissue of RFA-CA-16-013

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-CA-17-021

Companion Funding Opportunity

RFA-CA-17-019, R01 Research Project Grants

RFA-CA-17-020, U01 Research Project - Cooperative Agreements

RFA-CA-17-022, P50 Specialized Centers    

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

 93.393, 93.394, 93.395, 93.396, 93.399   

Funding Opportunity Purpose

 This Funding Opportunity Announcement (FOA) invites revision applications from currently funded NCI P01 Program Projects. These revision applications are expected to focus on research related to one of the 12 of the NCI's Provocative Questions (PQs) published in RFA-CA-17-017 and RFA-CA-17-018 that are intended for new R01 and R21 applications, respectively. This FOA encourages research that directly addresses PQs, including research that helps validate PQ research outcomes or adopt and disseminate PQ research results that impact cancer research and clinical care. Studies proposed in the revision applications must correspond to a new research project expanding the scope, yet integrated into the overall theme, of the entire parent P01 award. 

Key Dates
Posted Date

March 13, 2017

Open Date (Earliest Submission Date)

May 28, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

June 28, 2017; October 30, 2017; June 28, 2018; October 30, 2018, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.

No late applications will be accepted for this Funding Opportunity Announcement.

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

October-November 2017; March-April 2018; October-November 2018; March-April 2019  

Advisory Council Review

January 2018; May 2018; January 2019; May 2019

Earliest Start Date

April 2018

Expiration Date

October 31, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

  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.

Learn more about the various submission options.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), invites revision applications from currently funded NCI P01 Program Projects with at least two (2) years of support remaining on the parent grant at the estimated time of award. This FOA encourages sound and innovative research that directly addresses the PQs, including research that helps validate PQ research outcomes or adopt and disseminate PQ research results that impact cancer research and clinical care (http://provocativequestions.nci.nih.gov).  Studies proposed in the revision applications must correspond to a new research project, expanding the scope the parent Program Project grant. There are also two FOAs intended for new project applications (RFA-CA-17-017, and RFA-CA-17-018 for R01, and R21 grants, respectively.)

To be responsive to this FOA, each application must specifically address a particular scientific problem identified as one of the PQs listed in this FOA.

Background

The objective of the Provocative Questions Initiative is to stimulate specific areas of cancer research that are understudied, neglected, paradoxical, and/or have been difficult to address in the past. As with past issuances of the program, FOA publication has been preceded by several NCI-sponsored workshops to identify, articulate, and prioritize particularly compelling but understudied problems in cancer research to create a list of PQs.

The PQs included in this revision application FOA are identical to the PQs in RFA-CA-17-017 (R01) and RFA-CA-17-018 (R21). The current list of 12 PQs represents diverse fields relevant to cancer research, but all are framed to inspire interested scientists to conceive new approaches and/or feasible solutions. These PQs are not intended to represent the full range of NCI's priorities in cancer research. Rather, they are meant to challenge cancer researchers to think about and elucidate specific problems in key areas of cancer research that are deemed important but have not received sufficient attention.

The Nature of Scientific Problems Underlying PQs

Regardless of topical area, most scientific problems underlying the corresponding PQs fall into one of three broad types:

  • Ignored or neglected cancer-relevant problems that are brought back into focus.  These problems typically relate to intriguing older observations or unresolved issues, for which satisfactory, rigorous research answers may open up qualitatively new research avenues and/or result in substantial progress in a given area.
  • More recent findings that are perplexing or paradoxical, revealing important gaps in current knowledge. Research answers to these problems are expected to have exceptionally high potential to re-shape current key conception and paradigms about cancer. 
  • Problems of recognized high importance that were previously particularly difficult to explore but became more addressable because of recent scientific discoveries and technical advances.

List of PQs for this FOA:

Each application must address one and only one specific PQ from the list below, exactly as defined in this FOA. In order to facilitate the submission and peer-review processes, PQs are numbered 1-12. However, the order of the numbering of questions is arbitrary and should not be construed to indicate any order of priority or funding potential.

PQ1: What molecular mechanisms influence disease penetrance in individuals who inherit a cancer susceptibility gene?

Intent: Individuals who carry a mutation in a cancer susceptibility gene, for example individuals with Li-Fraumeni, Cowden, or Lynch Syndrome, have a dramatically increased risk over non-carriers of developing cancer.  This Provocative Question calls for research to determine how the rate of disease penetrance is influenced by various life experiences such as environmental exposure, patient natural history (e.g., abnormal changes in hormone levels), or interactions with other genes/biological pathways.  The intent of this question is to go beyond association studies, which identify factors that change disease penetrance in individuals with an inherited cancer susceptibility gene, and determine the mechanisms that explain how these changes influence disease occurrence.  Mechanistic studies of events that either increase or decrease rates of penetrance are suitable for study.  Preclinical or computational models may also be used to understand how disease penetrance may be altered.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ2: How do variations in immune function caused by comorbidities or observed among different populations affect response to cancer therapy?

Intent: Although the immune system has the potential to detect and eliminate cancer, considerable variability in immune function exists among populations and in response to comorbidities. These variations may help to explain observed differences in response to cancer therapies among patients and different populations. This Provocative Question seeks applications that will identify and/or validate immune response variations among cancer patients (including tumor-associated immune responses and/or host immune responses) and investigate how these variations may positively or negatively affect response to cancer therapy.  Successful applications might include mechanistic or epidemiological studies to investigate how population-based differences in immune traits (e.g., across such populations as racial/ethnic groups, age groups, and/or gender) can influence therapeutic outcomes.  Furthermore, applications may seek to determine how comorbid conditions (e.g obesity, heart disease, diabetes, etc.) may influence immune function and elucidate mechanism(s) by which this influence may affect therapeutic responses.   

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ3: Do genetic interactions between germline variations and somatic mutations contribute to differences in tumor evolution or response to therapy?

Intent: Cancer is characterized by numerous genetic and epigenetic alterations occurring in both the germline and somatic (i.e., tumor) genomes. Independently, projects focused on characterizing the germline and tumor genomes have led to improved understanding of cancer etiology and biology that will be exceedingly valuable as starting points for the identification of prognostic, diagnostic and therapeutic markers as well as therapeutic targets for the development of new treatments. This Provocative Question seeks research that would integrate germline and somatic genetic data in a systematic manner to gain a comprehensive picture of how the genetics of both the person and the tumor interact to affect tumor evolution, progression, or response to therapy.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ4: Can we develop tools to directly change the expression or function of multiple chosen genes simultaneously and use these tools to study the range of changes important for human cancer?

Intent: Progression of human cancers is driven by the simultaneous dysregulation of multiple genes and gene products. However, these changes are often studied in isolation or in experimental systems that are not amenable to multiple genetic or epigenetic perturbations. This Provocative Question calls for development of approaches and systems that enable simultaneous, sequential, and/or spatially controlled tuning of the expression or function of multiple chosen genes in cancer-relevant mammalian systems. Applications must be grounded in a context of human cancer, and successful applications should demonstrate that the proposed approach facilitates modulation and quantification of phenotypes relevant to human cancer progression and/or response to treatment, ideally within an in vivo or ex vivo system.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ5: How does mitochondrial heterogeneity influence tumorigenesis or progression?

Intent: Mitochondria within one cell, among closely related cells, or between different individuals can display heterogeneity in mtDNA sequences, proteome, morphologic and spatial dynamics, and functional capacities. This Provocative Question asks researchers to propose mechanistic studies that will characterize how mitochondrial variation within individual tumor cells, among cells within tumor microenvironment(s), or in the same cell types from different individuals influences tumorigenesis or progression. Successful applications will examine how mitochondria vary over time and how they alter or contribute to tumor development, adaptation, stemness, phenotypic plasticity, resistance, invasion and metastasis.  Research that examines whether mitochondrial heterogeneity can be used as a basis for disease monitoring, understanding response to therapy, or in the development of new therapies is also encouraged.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ6: How do circadian processes affect tumor development, progression, and response to therapy?

Intent: Circadian processes, driven by natural 24-hour rhythms, maintain the internal clocks critical for physiological homeostasis and adapting to a fluctuating environment. On a molecular level, circadian processes are regulated by a core transcription-translation negative feedback loop that drives expression and oscillatory regulation of genes that coordinate processing information from both extrinsic (i.e., light/dark, wake/sleep) and intrinsic (i.e., nutrient/hormone/inflammatory) stimuli. This Provocative Question seeks research to understand the mechanisms by which circadian or other oscillatory processes, and the consequences of their disruption, influence cancer development and outcomes. Such influences likely involve interactions across multiple time scales and levels (molecular to organismal) and involve both circadian and other oscillatory processes. Applications that focus on one scale or bridge multiple scales are equally encouraged, as are applications from researchers across all cancer-related disciplines from cell biologists to biobehavioral and population scientists, oncologists, clinicians, translational scientists, and care givers. Understanding how circadian and other oscillatory processes influence cancer development, progression, and response to therapy should illuminate potential new avenues to manage or treat cancer.

Applications that do not explore issues presented in this Intent Statement will be withdrawn as scientifically nonresponsive to this Provocative Question.

PQ7: How do cancer-specific subcellular pathognomonic structures develop, what is their function, and can they be a source of novel therapeutic targets?

Intent: Our current understanding of pathognomonic structures characteristic for cancers is limited.  Pathologists are trained to recognize and classify cancers based on distinct features and patterns in cells and tissues, most routinely aided by stains and conventional microscopy. This provocative question seeks research applications that expand the concept of pathognomonic figures. Can technologies be advanced to reveal the existence of new pathognomonic forms or features at the subcellular scale or bridging multiple scales? Mechanistically, how are pathognomonic structures formed, what are their cancer biology dynamics and function, and how do they contribute to distinct cancer phenotypes? How might this information be leveraged to improve detection, diagnosis or develop new treatment strategies? One goal of the PQ7 is to encourage interdisciplinary science that fosters innovation and new insights on basic pathognomonic cancer biology and its utility to inform and advance strategies to advance our understanding of cancer biology on a subcellular level.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ8: What are the predictive biomarkers for the onset of immune-related adverse events associated with checkpoint inhibition, and are they related to markers for efficacy?

Intent: Immune checkpoint inhibitors, including anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and anti-programmed cell death protein 1 (PD-1) or its ligand 1 (PD-L1) monoclonal antibodies (mAbs), enhance anti-tumor immune responses in multiple cancers through restoration of T-cell function. However, many patients treated with immune checkpoint inhibitors experience variable degrees of immune-related adverse events (irAEs) in diverse organ systems. If these irAEs are identified early, they can be managed properly. It has also been reported that clinical response to anti-CTLA-4 mAb is potentially associated with the presence of irAEs. This Provocative Question (PQ) invites research applications for identification and/or validation of mechanistic biomarkers for prediction of on- or post-treatment irAEs associated with therapies involving immune checkpoint inhibitors. This PQ also encourages unbiased evaluation of the relationship between biomarkers of irAEs and extended survival benefits in cancer patients treated with immune checkpoint inhibitor therapies. The ultimate goals of this PQ are to provide clinically-validated biomarkers that may inform clinical trial designs, and guide physicians to select and sequence therapies involving immune checkpoint inhibitors for the purpose of reducing or avoiding life-threatening irAEs in individual cancer patients.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ9: Can we develop bifunctional small molecules that will couple oncoproteins or other cancer causing molecules of interest to inactivating processes such as degradation and achieve tissue-specific loss of function?

Intent: Proteolysis Targeting Chimeras, or PROTACs, are heterobifunctional small molecules that link targeted proteins to the E3 ubiquitin ligase system, leading to target protein degradation through the ubiquitin-proteasome system. This Provocative Question seeks to extend the concept of inactivating oncoproteins or cancer-causing molecules through the use of bifunctional molecules, defined as small molecules that include a ligand moiety specific for a target oncoprotein or cancer-causing protein, linked to a second moiety involved in protein inactivation (inactivation moiety). The ultimate goal of this PQ is identification and/or preclinical development of novel bifunctional molecules that lead to tumor-specific loss or inactivation of selected target proteins for therapeutic benefit. Studies that test this concept on currently “undruggable” targets are encouraged as are studies that use novel protein inactivation moieties. Responsive applications may focus on design of bifunctional molecules, and/or testing of the biological functions of new or existing bifunctional molecules.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ10: How do microbiota affect the response to cancer therapies?

Intent: This Provocative Question seeks grant applications that use our increasing knowledge of the resident human microbiota to understand how these organisms or their secreted products affect cancer therapies. Approaches may include studies that focus on effects of the changing microbiota (i.e. their alteration of host barrier, metabolic, and immune functions) within an individual patient undergoing treatment or among different patients undergoing identical therapy but with different outcomes.  Analogous studies in pre-clinical models are also invited.  Key aspects of study might include either how the microbiota alter the composition, concentration, stability, or effectiveness of standard or experimental classes of therapies, or the identification and study of microbial regulatory mechanisms that mediate these changes.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ11: Through what mechanisms do diet and nutritional interventions affect the response to cancer treatment?

Intent: This Provocative Question seeks grant applications that address how diet and nutritional interventions affect the response to cancer treatment, treatment-related adverse events, cancer prognosis and related health outcomes. All types of studies that serve to elucidate the mechanisms of how diet and nutrition effect cancer outcomes are encouraged, including clinical trials, observational studies, and mechanistic studies in animals and humans. Transdisciplinary research and studies which consider multidimensional and/or dynamic dietary patterns (where dynamism includes the timing of meals and circadian rhythms, as well as changing diets over the course of treatment and survival) are also encouraged. Research applications may examine the association of diet and nutritional interventions with a range of outcomes among cancer patients and survivors, but should also address the mechanisms (such as influence of the microbiome, metabolome, immunology, and epigenetics) by which these relationships occur. Proposed studies should take into account other known prognostic factors that may influence cancer and related outcomes, such as weight/body composition, activity levels, and other lifestyle factors.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

PQ12: What are the molecular and/or cellular mechanisms that underlie the development of cancer therapy-induced severe adverse sequelae?

Intent: While many acute toxicities can be adequately managed during cancer therapy (e.g., febrile neutropenia, acute nausea and vomiting) and will resolve once therapy has been completed (e.g., mucositis), there are other adverse sequelae that persist after completion of therapy and for which there are no effective management strategies. These include, but are not limited to, therapy-induced peripheral neuropathy, neurocognitive impairments, cardiovascular toxicity, pulmonary fibrosis, arthralgias, and immune system-related adverse events. This Provocative Question seeks research that will (1) identify novel mechanisms that induce such chronic sequelae, (2) apply the knowledge gained from understanding these mechanisms to facilitate design of new treatments (or approaches) that may decrease or reverse adverse cancer therapy effects, or (3) facilitate mechanism-based design of new cancer therapies that are expected to show decreased adverse effects when compared with existing therapies.  Such studies may be performed in pre-clinical, non-clinical, and/or clinical settings. Successful applications must focus on adverse therapy related sequelae (whether immediate or delayed in onset) for which current management or treatment strategies are limited or ineffective.

Applications that do not explore issues presented in this Intent Statement will be considered nonresponsive to this Provocative Question.

Specific Requirements

Scientific Scope. The collective scientific scope of this FOA is defined by the list of PQs. These PQs define research areas appropriate for this FOA. They should NOT be construed as examples of specific topics. The scientific scope of each individual application must clearly and distinctly correspond to one (and only one) of the PQs listed above. Within an area defined by a given PQ, applicants may propose and pursue any topic they deem relevant as a "research answer" to that PQ. It is important, however, that applicants carefully read the Intent Statement for each PQ. Additional information for each PQ pertaining to context, background, feasibility, and expectations of needs to be accomplished for a successful solving of the problem is available on the Provocative Questions web site (provocativequestions.nci.nih.gov). 

Individual Goals. Within the research area defined by a specific PQ chosen, the overarching goal of the proposed research project must be an attempt to provide definitive, comprehensive, and thorough research answers to the problem or portions of the problem presented by that question. The proposed research solutions are expected to be creative and highly original with a high potential for transformative impact on current concepts and paradigms in cancer research.

Within this general requirement, specific topics for the proposed investigations, strategies, priority directions, and other details of study design and execution are left to the discretion, originality, and creativity of the applicants. The creativity and originality (combined with scientific rigor) are particularly important, given that the areas identified by the individual PQs are generally understudied. Therefore, the applicants have the full freedom to identify the most promising direction(s) to address the selected PQ, formulate Specific Aims, choose optimal experimental approaches, and adapt appropriate specific benchmarks as measures of accomplishing the overarching goal of the project. It is expected that these specific benchmarks will be in line with the Intent Statement for the selected PQ.

Original Rigorous Concepts versus Preliminary Data. In general, research projects under P01 awards are usually expected to be well-developed and supported by extensive preliminary data from researchers' laboratories. The requirement for well-developed projects extends to this FOA.

However, it is realized that for many of the PQs there could be gaps in background information and original preliminary data may be scarce or difficult to obtain beforehand. Since the intention of this FOA is, by definition, to exploit understudied areas, the emphasis is on the novelty and significance of the concepts to be explored with a relaxed requirement for preliminary data. These concepts must be original but also rigorous in terms of integrating to the extent possible the available incomplete information for a given area from various sources. Reviewers will assess both aspects jointly; if the conceptual aspects of the proposed project are viewed as exceptionally strong, applicants will not be penalized for some gaps in the preliminary data. The focus of the FOA is definitely on the "power of the ideas" (but combined with rigorous plans to validate those ideas).

Non-Responsive Projects

The following types of projects will be considered non-responsive to this FOA, and applications proposing such projects will not be reviewed:

  • Applications that fail to choose a specific PQ from the list above, address more than one PQ within a single application, and/or re-write a PQ; and
  • Applications that do not explore issues presented in the Intent Statement for the selected PQ (as defined in PQ description above).

IMPORTANT NOTE: Applicants uncertain as to whether their intended project meets the requirements of this FOA are encouraged to contact the Scientific/Research Contact listed below in Section VII.

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

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

Revision applications (for eligible NCI-supported P01 parent awards).

Resubmission (but only of Revision applications originally submitted in response to this FOA or a predecessor PQ revision FOA, but only if the identical PQ is being addressed).

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NCI expects to commit up to $750,000 (total cost) in fiscal year 2018, and an equivalent amount in FY2019 to this FOA. The number of awards is contingent upon the submission of a sufficient number of meritorious applications.

Award Budget

The budget may not exceed $150,000 in direct costs per year.    

Award Project Period

 Applicants may request support for up to two years, not to exceed the remaining number of years on the parent grant. The parent grant must be active when the application is submitted. If a no-cost extension is needed on the parent grant, it must be in place before the revision application is submitted.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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)

Governments

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

Other

  • 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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

 The PD/PI (or Contact PD/PI for multi-PD/PI awards) on the parent award must remain the same on the revision application.

If appropriate and desirable, applicant investigators (including a PD/PI) may collaborate on PQ Revision applications based on other parent awards.     

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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).

 If an applicant organization wishes to submit multiple revision applications based on the same P01 parent award, each revision application must address a different PQ and be based on different projects in the parent award.   

Section IV. Application and Submission Information
1. Requesting an Application Package

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

Emily J. Greenspan, Ph.D.
Office of the Director
National Cancer Institute
Telephone: 301-395-2871
Email: greenspanej@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Project (use for Research Project)

6

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

Instructions for the Submission of Multi-Component Applications

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

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

  • Overall: required
  • Research Project: required; maximum of 1
Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Outline the overall scientific scope of the parent award and the main goals of the already active research projects. Explain how the proposed revision research project will enhance research of the parent award.

Specific Aims:  List the Specific Aims of the parent award and explain how the proposed new project will relate to them.       

Research Strategy:  Research Strategy for Overall should be structured in sub-sections as defined below (instead of standard subsections defined in SF424 Application Guidelines).

Sub-section A. Provocative Question (PQ) Choice. Identify one (and only one) specific PQ from the list that is being addressed in the proposed project and briefly describe how you propose to provide an answer to the selected PQ using conceptually original but also rigorous strategy.

Sub-section B. Progress on the Parent Award. Summarize concisely the highlights of research progress made for the parent, including each funded project and shared resource core(s).

Sub-section C. Significance and Integration with Ongoing Research. Provide the rationale and justification for adding the proposed new project. Explain how it will affect the overall theme, goals, objectives, aims, and research strategy of the ongoing program.  

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Resource Sharing Plan should be provided only under the 'Overall' component but it should cover all the activities proposed for the Revision Research Project.

Appendix:

 Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

PHS Assignment Request Form (Overall)

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

Research Project

When preparing your application in ASSIST, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Resources: Describe any extraordinary aspects and/or resources that provide novel or enhanced opportunities to investigate the selected PQ in a way that would not be possible elsewhere even in generally excellent scientific environments. For example, list and explain any relevant unique, newly developed/acquired technical capabilities that are not available anywhere else.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
Budget (Research Project)

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

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

PHS 398 Research Plan (Research Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  Outline the Specific Aims of the proposed project.     

Research Strategy:  Describe the Research Project focused on the Provocative Question Choice identified in the Overall component. In Research Strategy, describe how you propose to provide an answer to the selected PQ using approaches that are expected to be conceptually original but also rigorous. Use the standard Research Strategy subsections (Significance, Innovation, and Approach) as defined in SF424 Application Guide. This description should also address all the specific aspects listed below.

  • Explain the likelihood that the project will yield far- or broad-reaching advances in the understanding of the research problem defined by the selected PQ.
  • For high-risk projects: indicate the potential benefits that would justify taking high risks.
  • Explain the originality of the concepts and/or proposed research directions relative to any ongoing work and point to other creative, innovative aspects that go beyond simply taking the next logical step.
  • If supporting preliminary data are limited or incomplete, explain and justify the exceptional strength of conceptual aspects.
  • Outline the strategy to optimize the experimental design to ensure generation of informative results for the selected PQ (ideally, even negative results should be informative)

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Resource Sharing Plans should only be included in the Overall component of the application.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.    

PHS Inclusion Enrollment Report (Research Project)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.  

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

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

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

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.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

To be viewed as having potential high impact, the proposed revision research as designed, must be likely to yield far- or broad-reaching advances in the understanding of the research problem defined by the selected PQ. Thus, potential impact of the applications will be judged in large part on the power of the ideas behind the proposed research.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the proposed revision research 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 research proposed).

Scored Review Criteria - Overall

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 revision research address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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 extent is this proposed revision research, as designed, likely to yield far- or broad-reaching advances in our understanding of the selected PQ?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their 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?  

Innovation

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

Specific to this FOA: Does the proposed revision research provide opportunity for novel findings that would be informative as answers for the selected PQ? For high risk projects, is the potential for benefit justifiably high? In cases where the proposed revision research is an extension of ongoing work, does it address truly original concepts and/or research directions not covered by the ongoing work and/or use preliminary data in a creative, innovative way rather than simply taking the next logical step?  

Approach

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

If the research 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 children, justified in terms of the scientific goals and research strategy proposed?  

Specific to this FOA: Is the experimental design optimal to ensure generation of important information for the selected PQ? If negative results are obtained, how likely is it that these results will be informative for our understanding of the selected PQ? Do the applicants propose a conceptually original and rigorous strategy to solve the problem defined by the selected PQ? If supporting preliminary data are limited or incomplete, how well are such gaps compensated by exceptional strength of conceptual aspects?  

Environment

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

Specific to this FOA: Are there any extraordinary aspects and/or resources that provide novel or enhanced opportunities to investigate the selected PQ in a way that would not be possible elsewhere even in generally excellent scientific environments? For example, are there any unique, newly developed/acquired technical capabilities (without which the project could not be proposed) that are not available anywhere else?  

Additional Review Criteria - Overall

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 six 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 six 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 Children 

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 children 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 Animal 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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 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 .

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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 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.

Prior Approval of Pilot Projects

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

Emily J. Greenspan, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-395-2871
Email: greenspanej@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)

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@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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