Generally the First Stage of an Alternative Dispute Resolution System Is Peer Review

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(south)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Inquiry Projects in Cancer Systems Biology (U01 Clinical Trial Optional)

Activity Code

U01 Research Project – Cooperative Agreements

Related Notices

Run into Notices of Special Interest associated with this funding opportunity

September 1, 2021 - Notice of Change to the Expiration Date and the Concluding Receipt Date of PAR-nineteen-287, "Research Projects in Cancer Systems Biological science (U01 Clinical Trial Optional)". Meet Find Non-CA-21-110.
Janaury 27, 2021 - Observe of Special Interest (NOSI): Understanding the effects of cancer and cancer treatment on aging trajectories and aging outcomes. See Notice NOT-CA-21-031.
March 10, 2020 - Reminder: FORMS-F Grant Awarding Forms & Instructions Must be Used for Due Dates On or Afterward May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.
August 23, 2019 - Clarifying Competing Application Instructions and Find of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Inquiry. Encounter Notice NOT-OD-19-137.
July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. Come across Notice NOT-OD-19-128.

Funding Opportunity Announcement (FOA) Number

PAR-19-287

Companion Funding Opportunity

None

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

93.396, 93.395

Funding Opportunity Purpose

The National Cancer Institute's (NCI) Cancer Systems Biology Consortium (CSBC) supports systems biological science approaches to cancer research and includes U54 CSBC Research Centers, a U24 CSBC Coordinating Centre and, through this FOA, well-divers, detached and circumscribed U01 Research Projects. CSBC Inquiry Projects are expected to involve interdisciplinary teams of scientists, engineers, and cancer researchers who collaborate to advance our agreement of the mechanisms underlying cancer initiation, progression, and treatment. CSBC Research Projects proposed in response to this Funding Opportunity Announcement must be based upon explicit integration of experimental biological science and computational modeling to examination and validate novel hypotheses in cancer research.

Key Dates

Open up Date (Primeval Submission Engagement)

June 15, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

July xv, 2019, November 15, 2019, July 10, 2020, November 17, 2020, July 9, 2021, Jan 28, 2022, by 5:00 PM local time of bidder organization. All types of not-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to let adequate time to make whatever corrections to errors institute in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October-Nov 2019, Feb-March 2020, October-November 2020, February-March 2021, October-November 2021, February-March 2022

Advisory Quango Review

January 2020, May 2020, Jan 2021, May 2021, January 2022, May 2022

Earliest Start Appointment

April 2020

Expiration Date

New Date Jan 29, 2022 per issuance of NOT-CA-21-110

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Inquiry (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Detect from the 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 awarding instructions in the Awarding Guide as well as whatsoever program-specific instructions noted in Department Four. When the program-specific instructions deviate from those in the Application Guide, follow the programme-specific instructions. Applications that practise not comply with these instructions may be delayed or not accepted for review.

Tabular array of Contents

Part 1. Overview Information
Part ii. Full Text of the Declaration

Section I. Funding Opportunity Clarification
Section II. Award Data
Department 3. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Department VI. Accolade Assistants Information
Department VII. Agency Contacts
Section Viii. Other Information

Part 2. Full Text of Annunciation

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit research projects addressing challenging cancer problems using systems biological science approaches. In back up of this goal, the National Cancer Plant (NCI) has created the Cancer Systems Biology Consortium (CSBC).

Currently, the CSBC consists of:

Several U54 CSBC Inquiry Centers (supported under RFA-CA-15-014);
One U24 Coordinating Centre (supported under RFA-CA-15-015);
Several specialized U01 Inquiry Projects (currently supported under PAR-16-131; the U01 Research Projects to be supported under this FOA volition be added to this pool).

Information about the scientific goals of the currently funded CSBC Research Centers and Inquiry Projects tin be found at www.csbconsortium.org.

CSBC U01 Research Projects proposed in response to this FOA should accost a well-defined, discrete, and circumscribed research question in cancer incorporating quantitative experimentation, analysis, modeling, and validation, which are the hallmarks of systems biology.

Groundwork

The Cancer Systems Biological science Consortium (CSBC), which began in 2016, supports projects that apply cancer systems biology approaches focusing on disease mechanism. CSBC defines "cancer systems biology" as a holistic approach to the report of the complexities of cancer through the explicit integration of experimental biology and computational and mathematical methods to build predictive models of cancer that are tested or validated in a disease-relevant context. This definition requires an iterative framework, encourages interdisciplinary research, and leverages resource developed in other NCI programs. Because the range of specific cancer questions addressed past applicants to the CSBC is non prescribed, the unifying theme of the CSBC is the common pursuit of a mechanistic understanding of disease through the matrimony of experiments and computation. In a distinct, simply complementary fashion, NCI supports programs to develop bioinformatics technologies (NCI Informatics Technologies for Cancer Enquiry) and multiplex genomics screening efforts for drug development (NCI Cancer Therapeutic and Drug Discovery Network) which have resulted in novel algorithmic and experimental approaches.

General Objective and Structure of The Cancer Systems Biology Consortium

The CSBC initiative is intended to promote further development of the field of cancer systems biological science.

CSBC overall arrangement: Currently, the CSBC consists of U54 CSBC Research Centers, U01 CSBC Research Projects and a U24 Coordinating Center that coordinates activities betwixt the CSBC and a related program, the Physical Sciences in Oncology Network (PS-ON). All parts will exist governed past the CSBC Steering Commission with representatives from the currently funded CSBC U54 Research Centers and U01 Research Projects, the CSBC/PS-ON Coordinating Heart and NCI Program staff. Applicants are encouraged to visit the CSBC website for more information regarding the role of the U24 CSBC/PS-ON Coordinating Center. The CSBC functions equally a collaborative network allowing Research Centers and Projects to leverage resources, cross-test ideas, integrate diverse information sets, and validate (or refute) theoretical, experimental, or clinical models through monthly teleconferences, annual in-person meetings, and various scientific working groups.

As part of the CSBC, the U01 Research Project awardees to exist supported under this FOA will exist required to participate in Consortium activities (for details see Section Six.two Cooperative Understanding Terms and Weather condition of Honor.)

Governance of the CSBC: The CSBC program will be governed by the CSBC Steering Committee. This governance extends to CSBC U01 Enquiry Projects (meet Section Vi: Terms and Conditions of Cooperative Agreement.)

Evaluation of the Program: CSBC awardees (including Research Projects awardees) will be required to participate in an external evaluation process of the CSBC program coordinated by NCI Program Staff (meet Section 6: Terms and Atmospheric condition of Cooperative Agreement.)

Scope and Objectives of CSBC Research Projects nether this FOA

Applicants responding to this FOA should propose only ane single, cohesive project that is based upon a systems biology approach to cancer research. This approach should include explicit integration of experimental biology and computational or mathematical modeling to build, test and/or validate hypotheses or ideas.

At that place are a multifariousness of cancer research areas that are especially amenable to a systems biology arroyo. Examples include, just are not express to:

Decoding dynamic tumor-stroma and/or tumor-immune system interactions, including understanding the mechanisms past which the dynamics of these interactions influence tumor evolution and/or progression;
Building integrated models of chemic, molecular, structural, network, and localization information across space and time to understand tumor initiation, progression, and metastasis;
Quantifying how private jail cell states and behaviors (tumor and non-tumor) shape tumor ecosystems, including mathematical modeling of single-prison cell dynamics or development and testing of combined experimental and computational approaches that quantify how private cell behaviors manifest at the tumor, organ, and whole-body levels;
Determining the mechanisms by which external factors, such as the microbiome, affect tumor initiation, progression or treatment; and
Bridging the many cancer hierarchies through the integration of molecular systems biology and population-scale models of cancer, including the apply of mathematical or statistical formalisms to span a mechanistic systems biology model at one scale and a population-level model at the other.

Potential applicants are encouraged to visit the CSBC website or NIH Reporter to learn more nearly what U01 Enquiry Projects are included in the CSBC portfolio. A diversity of systems biological science approaches and cancer questions are of programmatic interest. Potential applicants are encouraged to contact NCI Program Staff prior to submission with questions regarding project goals and scope.

The emphasis of the proposed U01 projects must be on a specific cancer-relevant question or hypothesis. Nonetheless, such projects may include appropriate efforts to develop new experimental and/or computational and/or mathematical systems biological science approaches. Note: for projects entirely focused on methods or tools development, applicants should consider culling initiatives, such as those under the Informatics Technologies for Cancer Enquiry or Innovative Molecular Analysis Technologies programs. For projects focused on the physics of cancer, applicants should consider the Physical Science-Oncology Network.

Research with Human Subjects. Inquiry involving human subjects, albeit not required, is permitted under this FOA, including inquiry that meets the NIH definition of clinical trials stated in Not-OD-15-015. However, if such studies are proposed, they must be mechanistic (e.one thousand., designed to understand a biological phenomenon, etiology of disease, or machinery of action) and Non focused on the development of application of an intervention.

Resource Relevant to CSBC Research Projects

CSBC Research Project awardees volition have the opportunity to take advantage of consortium-wide working groups and organizations and will be expected to participate in consortium-related activities within the CSBC.

Depending on the focus of a given Research Project, interactions with investigators from other NCI-supported consortia may exist appropriate. In item, Research Projects focused on bridging molecular and population-level models may benefit from access to the resource inside the NCI Cancer Intervention and Surveillance Modeling Network (CISNET).

Non Appropriate for This FOA

The post-obit are examples of projects that are not appropriate for this FOA:

Enquiry projects focused on purely bioinformatic analyses of omics information that are not borne of a specific, testable hypothesis;
Research projects for which experimental validation or testing of systems biology predictions within a relevant cancer context is not proposed;
Research Projects proposing correlative studies related to host-microbiome interaction (or similar ecology factor) with no underlying mechanistic interrogation, or those cataloging changes in the microbiome (or similar ecology gene) due to tumorigenesis or drug treatment without a cancer systems biology model;
Research Projects proposing validation of clinical correlative statistical models, such as validation of hits from GWAS, in the absence of the study of disease mechanism; and
Research project proposing clinical trials that include clinical development or testing of therapeutic interventions, evaluation of intervention safety, efficacy, clinical direction etc. will be viewed as low programmatic priority.

See Department Eight. Other Information for honor regime and regulations.

Section II. Honour Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement ways that, later award, NIH scientific or program staff volition assist, guide, coordinate, or participate in projection activities. See Section Vi.2 for additional information near the substantial involvement for this FOA.

Application Types Allowed

Funds Available and Predictable Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Honor Upkeep

Awarding budgets are limited to $400,000 in direct toll per year and must reverberate the actual needs of the proposed project.

Award Projection Period

Project periods of up to five years may be proposed.

NIH grants policies equally described in the NIH Grants Policy Statement will utilise to the applications submitted and awards fabricated from this FOA.

Section 3. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

The following types of College Instruction Institutions are e'er encouraged to utilize for NIH support as Public or Private Institutions of College 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 Educational activity

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 Instruction)

For-Turn a profit Organizations

Pocket-size Businesses
For-Profit Organizations (Other than Pocket-size Businesses)

Governments

State Governments
County Governments
Eligible Agencies of the Federal Regime
U.S. Territory or Possession

Other

Non-domestic (non-U.Due south.) Entities (Foreign Institutions)

Foreign Institutions

Not-domestic (not-U.South.) Entities (Foreign Institutions) are eligible to utilize.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must consummate and maintain the post-obit registrations as described in the SF 424 (R&R) Application Guide to be eligible to use for or receive an accolade. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more than, so applicants should brainstorm the registration procedure equally shortly as possible. The NIH Policy on Late Submission of Grant Applications states that failure to consummate 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 exist issued a DUNS number. After obtaining a DUNS number, applicants tin begin both SAM and eRA Eatables registrations. The same DUNS number must be used for all registrations, besides as on the grant application.
System for Award Direction (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal procedure may crave as much time as the initial registration. SAM registration includes the assignment of a Commercial and Regime Entity (Muzzle) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Lawmaking – 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 to annals in eRA Eatables. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, merely all registrations must be in identify past time of submission. eRA Commons requires organizations to place at least 1 Signing Official (And then) and at to the lowest degree 1 Program Managing director/Principal Investigator (PD/PI) business relationship in order to submit an application.
Grants.gov – Applicants must accept an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(south)/PI(southward) must have an eRA Commons business relationship. PD(s)/PI(s) should work with their organizational officials to either create a new business relationship 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 Eatables account can take upwards to ii 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 Programme Managing director(s)/Principal Investigator(s) (PD(due south)/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 e'er encouraged to apply for NIH support.

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

Due to the multi-disciplinary nature of the projects and the focus on collaboration and expertise sharing, this FOA encourages the use of the multi-PD/PI mechanism.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more one application, provided that each application is scientifically singled-out.

The NIH will not have 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 awarding that has substantial overlap with another application pending entreatment of initial peer review (run across Non-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 organization-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 lot programme to use an institutional organization-to-system solution.

ii. Content and Class of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except 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.

Alphabetic character of Intent

Although a letter of intent is not required, is non binding, and does not enter into the review of a subsequent application, the data 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(south) of the PD(s)/PI(s)
Names of other primal personnel
Participating establishment(s)
Number and title of this funding opportunity

The alphabetic character of intent should be sent to:

Shannon Hughes, Ph.D.
Partition of Cancer Biology (DCB)
National Cancer Institute (NCI)
Phone: 240-276-6224
Email: Shannon.Hughes@nih.gov

Folio Limitations

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

Instructions for Awarding Submission

The following section supplements the instructions constitute in the SF424 (R&R) Awarding Guide and should exist used for preparing an awarding to this FOA.

SF424(R&R) Cover