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
Cancer Adoptive Cellular Therapy Network (Can-ACT) Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices
  • August 29, 2022 - Notice of Pre-application Webinar for Cancer Adoptive Cellular Therapy Network (Can-ACT) for Adult (RFA-CA-22-028) and Pediatric Cancers (RFA-CA-22-029), and Coordinating Center (RFA-CA-22-030). See Notice NOT-CA-22-123.
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
Funding Opportunity Announcement (FOA) Number
RFA-CA-22-030
Companion Funding Opportunity
RFA-CA-22-028 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
RFA-CA-22-029 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
Assistance Listing Number(s)
93.395
Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) intends to support a coordinating center to manage the Cancer Adoptive Cell Therapy (Can-ACT) Network a network of UG3/UH3 awardees that will conduct adoptive cell therapy research and clinical trials for patients with solid tumors (see companion UG3/UH3 FOAs - RFA-CA-22-028 and RFA-CA-22-029). The U24 Coordinating Center will organize and administer a Steering Committee for the Can-ACT Network to ensure that the goals of the network are achieved. The Coordinating Center will oversee the management of network activities to facilitate multi-site clinical trial coordination and data collection, harmonization, quality, and sharing.

Key Dates

Posted Date
August 24, 2022
Open Date (Earliest Submission Date)
September 28, 2022
Letter of Intent Due Date(s)

30 days prior to application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 28, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

Expiration Date
October 29, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) intends to support a Coordinating Center to manage the Cancer Adoptive Cell Therapy Network (Can-ACT), a network of UG3/UH3 awardees (see companion UG3/UH3 FOAs - RFA-CA-22-028 and RFA-CA-22-029) that will conduct research and early phase/proof of principle adoptive cell therapy clinical trials for patients with solid tumors. The U24 Coordinating Center will organize, lead, and administer a Steering Committee for the Can-ACT Network to ensure that the goals of the network are achieved. The Coordinating Center will facilitate the receipt and review of administrative research supplements intended to support related research on newly emerging cell therapy technology, to invite collaborators into the network, or to enhance collaborations within the Can-ACT Network. In addition, the Coordinating Center will facilitate network activities to achieve multi-site clinical trial coordination and data collection, harmonization, quality, and sharing.

Background

Progress in cancer adoptive cell-based therapy (ACT) for hematologic malignancies, along with an enhanced understanding of the tumor immune microenvironment and advances in cellular and molecular technologies, has now permitted the expansion of ACT to solid cancers. ACT can be further divided into several subtypes, among them: 1) chimeric antigen receptor (CAR) T-cell therapy; 2) tumor-infiltrating lymphocyte (TIL) therapy; 3) engineered T cell receptor (TCR)-T cell therapy; and 4) natural killer (NK) cell and dendritic cell (DC) therapies. CAR T-cell therapies are the best studied and most widely known, as several have been approved by the Food and Drug Administration (FDA) for the treatment of patients with acute lymphoblastic leukemia, non-Hodgkin lymphoma, and multiple myeloma. However, improvements in adoptive cell therapeutic strategies are needed to effectively treat adult cancer patients with solid tumors.

The NCI has a long history of supporting the immuno-oncology research community in basic, translational, and clinical studies through grants and clinical trial networks. The NCI convened workshops in 2018 and 2020 to identify areas of need in cell-based immunotherapy for solid tumors. These meetings brought together extramural academic researchers, industry scientists, FDA representatives, and NCI staff, allowing NCI to gain insight on major challenges and future directions in the field (see published meeting summary).

Existing needs identified by the ACT community for further development of cell-based strategies for solid tumors include: improved manufacturing approaches, studies of immune cell fitness/persistence and trafficking, strategies to overcome the immunosuppressive tumor microenvironment, development of novel biomarkers and imaging methods, a core laboratory to measure critical quality attributes of manufactured cell products and perform quality control (QC) testing on cell therapy-related reagents, and support for small proof-of-concept clinical trials to rapidly gain knowledge of promising new treatment approaches.

In an effort to continue to support the ACT community, the NCI has established the Immune Cell Network Core Facility (ICN Core) at the Frederick National Laboratory for Cancer Research (FNLCR). The ICN Core has the capabilities for the production of GMP-grade cell products and vectors, and standardization of assays. The ICN Core will provide guidance for quality systems and regulatory affairs for all sites, when requested, and cell product manufacturing for multi-site clinical trials.

Organization of the Can-ACT Network

The Can-ACT Network is designed to accelerate the development and testing of adoptive cell therapy for solid tumors in adult and pediatric patients. The UG3/UH3 milestone-driven NCI-collaborative grant mechanism will allow awardees to explore novel cell therapy approaches and to generate preclinical IND-enabling data during the initial UG3 phase, and then rapidly test these approaches in early phase, proof of concept, or first-in-human clinical trials in the UH3 phase. The UG3/UH3 awardees are expected to communicate scientific approaches and data within the network. While single-site trials are permitted, the intent of the network is to leverage the Frederick National Laboratory for Cancer Research (FNLCR) Cell Production and Immune Cell Network Core (ICN Core) facilities and services for small multi-site trials to achieve timely accrual goals. The U24 Coordinating Center will facilitate interaction and cooperation between UG3/UH3 awardees, the FNLCR Cell Production and ICN Core facilities, and NCI project scientists and program officers.

Three FOAs listed below along with the ICN Core at FNLCR will support the Can-ACT Network:

  • Can-ACT for Adult Cancers (RFA-CA-22-028);
  • Can-ACT for Pediatric Cancers (RFA-CA-22-029); and
  • Can-ACT Coordinating Center (RFA-CA-22-030).

The NCI will work with the U24 Coordinating Center and Can-ACT network to determine how data from the cell therapy products used in the clinical trials supported under this FOA as well as the clinical trial data will be developed, collected, stored, shared, and maintained.

The Can-ACT Network will be governed by the Can-ACT Steering Committee.

Resources provided by NCI: Immune Cell Network (ICN) Core

The FNLCR houses the ICN Core, which will be providing services for the Can-ACT Network. What follows is the general assistance to be provided by the ICN Core. Based on the applications received, awards made, and ongoing guidance from the Division of Cancer Treatment and Diagnosis (DCTD), minor changes may be made to best align with the needs of the Can-ACT Network.

The ICN Core will facilitate and support the following activities:

  • Quality Oversight: The ICN Core will provide Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) compliance evaluations for the sites, as requested. The ICN core will perform virtual or on-site visits, as appropriate, for Good Clinical Laboratory Practices (GCLP) compliance.
  • Product Attributes Evaluation: In consultation with the Can-ACT members and NCI, the ICN Core will develop and standardize characterization assays for cell therapy products to be used for clinical trials. The ICN Core may produce and distribute key assay reagents and Standard Operating Procedures to Can-ACT members. The ICN Core will provide quality assurance and regulatory guidance to Can-ACT members, as well as guidance and review of materials for IND submission to the FDA.
  • Multi-site Trial Current Good Manufacturing Practice (cGMP) Production: The ICN Core will be available to Can-ACT member sites for the production, testing, release, and distribution of cGMP cell therapy products for multi-site Can-ACT clinical trials, including the coordination of autologous raw material and final product logistics between clinical and manufacturing sites. The ICN Core will develop innovative engineering and production processes, as needed.

Specific Research Objective and Requirements

The long-term objective of Can-ACT is to foster innovation and promote early-stage clinical testing of novel state-of-the-art cell-based immunotherapies for solid tumors in adults and pediatric patients and leverage NCI resources to support the cell therapy community. The U24 Coordinating Center will act as the hub for scientific and organizational leadership to the Can-ACT. The Coordinating Center, in conjunction with NCI staff, will facilitate collaborations within the network. The Can-ACT network will be governed by a Steering Committee established by the U24 Coordinating Center and composed of the funded UG3/UH3 awardees, as well as representatives from the Coordinating Center, the ICN Core, and NCI project scientists and program officers.

The U24 Coordinating Center will operate as supporting infrastructure for the Can-ACT network and will be responsible for providing coordinated support as outlined below:

  1. Scientific Coordination
  • Lead and administer Steering Committee for Can-ACT Network;
  • Coordinate collaborative research efforts that involve multiple Can-ACT centers;
  • Develop and implement a governance strategy for shared data use and develop a strategy to define critical data elements and minimal data collection requirements;
  • Provide bioinformatics and statistical support for Can-ACT projects;
  • Develop, maintain, and make accessible Can-ACT policies, resources, and standard operating procedures for the Can-ACT network members;
  • Coordinate receipt and facilitate review of the administrative supplements to expand the network of collaborators, enhance collaborative projects within the Can-ACT network, and to support related research on newly emerging cell therapy technology;
  • Identify new scientific areas of mutual interest;
  • Establish and support working groups around topics identified by Can-ACT award recipients in consultation with NCI staff;
  • Coordinate and assure communication between Can-ACT members, the ICN Core, NCI, and other sites added to the Can-ACT Network;
  • Develop strategic plans to promote Can-ACT activities and outreach, in coordination with NCI; and
  • Generate reports as required by the NCI.
  1. Administrative Coordination
  • Provide the necessary administrative infrastructure and develop a comprehensive communication plan to facilitate and coordinate all common activities of the Can-ACT network. The U24 Coordinating Center will coordinate the Steering Committee meetings (monthly and annual) and other virtual network meetings as required. Additional details on the composition and functions of the Can-ACT Steering Committee are provided in Section VI.2, Cooperative Agreement Terms, and Conditions of Award.
  • Serve as a communications hub for multi-center trial activities, providing guidance on best practices. This may include the establishment of working groups or committees and recurring meetings with Can-ACT sites to allow for efficient communications and consistencies across the network sites.
  • Support annual meetings of the Can-ACT network, provide logistics and potential travel support to annual workshops to present Can-ACT progress, provide relevant training related to IT/data, cGCP, cGMP, and GCLP compliance, and solicit input from the research community.
  • Develop and maintain a public-facing website for Can-ACT; this website will not house preclinical or clinical trial data.
  • Facilitate the procuring and sharing of reagents and specimens.
  • Design and implement a process for the network to establish standards for data types, formats, minimal requirements, compatibility for storage and analysis, integration, and sharing of clinical and correlative data among the network members in accordance with NIH Policy for Data Management and sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html).
  • Assist in the standardization of clinical and laboratory immune monitoring protocols.

Additional Information

Pre-Application Teleconference: A technical assistance teleconference will be held for potential applicants. NIH staff will be available to answer questions related to this FOA. The time, date, and dial-in information for the call will be announced in an NIH Guide Notice.

Non-responsive Applications

The following types of activities remain outside the scope of this FOA, and applications proposing them are non-responsive to this FOA and will not be reviewed:

  • Projects focused on scientific hypothesis testing or technology development;
  • Projects that do not address both scientific and administrative aspects of coordination; and
  • Projects that do not include a description of collaboration with the ICN Core.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NCI intends to commit $500,000 in FY 2023 to fund 1 award. Future year amounts will depend on annual appropriations.

Award Budget

Application budget may not exceed $300,000 in direct costs (excluding sub-award F&A costs) per year and must reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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 not 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.

  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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:

Kasia Bourcier, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute (NCI)
Telephone: 301-846-1101
Email: bourcierkd@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Specific to this FOA

Investigator(s)

The experience of the investigator will help with fostering scientific collaborations among grantees of the Can-ACT Network. The scientific expertise would strongly enable managing of a Steering Committee, and External Advisory Board, as well as a method for shared data governance, and centralized scientific and IRB review for multisite studies. The experience of the applicants should be adequate in creating a public-facing website. The scientific expertise of the team members in Immuno-Oncology/Cell-based therapies should be sufficient to contribute to the successful management of the outlined activities. The PI must dedicate at least 1.8 person months effort per year to the project for the life of the award. If the project has Multi-PIs, then each must dedicate at least 1.2 person months effort per year to the project for the life of the award.

R&R Budget

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

In addition, applicants must include provisions for:

Funds for Travel: Include the cost of participating in meetings and conferences including travel to annual in-person Can-ACT Steering Committee meetings and site visits to the ICN Core.

Budget requests must include travel costs for the PD(s)/PI(s) to attend the initial in-person kick-off meeting, and for the PD(s)/PI(s) and other members of the project team (up to four people in total) to attend the annual Can-ACT Investigators' meetings. Meetings will be held in the Washington DC metropolitan area. PDs/PIs are encouraged to include early career scientists in Can-ACT activities and should include budget to travel at least one graduate student or postdoctoral fellow to the Annual Investigators Meeting. The PI must dedicate at least 1.8 person months effort per year to the project for the life of the award. If the project has Multi-PIs, then each must dedicate at least 1.2 person months effort per year to the project for the life of the award.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Outline the specific aims of the proposed Coordinating Center.

Research Strategy: Applicants must organize the Research Strategy to include the subsection elements identified below. Applicants may include other sub-sections as needed but must include the information requested below.

Sub-section A. Scientific Coordination

  • Describe the overall vision of the Coordinating Center;
  • Describe how the applicant’s leadership experience will help with achieving Can-ACT goals;
  • Describe the organization and coordination of the Steering Committee, which will include voting representation from all UG3/UH3 awardees, U24 awardee, and NCI Program and Scientific Officers, as well as non-voting members from supplemental P30/P50 awardees and the ICN Core;
  • Describe the organization and coordination of an External Advisory Board;
  • Describe plans for facilitating collaboration between the research project investigators within Can-ACT;
  • Describe plans for coordination of receipt of administrative supplements;
  • Outline plans for an outreach strategy to promote Can-ACT to the wider scientific community;
  • Describe how the Coordinating Center will facilitate procurement and sharing of reagents, specimens, and coordinate strategy to define critical data elements and minimal data collection requirements and data sharing plans;
  • Describe how computational and bioinformatics support for data collection, management and visualization will aid Can-ACT;
  • Establish a governance policy for the utilization of shared data within the Can-ACT network; and
  • Describe plans for coordinating the management of clinical and correlative data and ensuring the data are adherent to specified data types, formats, standards for storage, analysis, reporting, integration, sharing, future reusability, and in compliance with the NIH Policy for Data Management and Sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html).

Sub-section B. Administrative Support

  • Describe the appropriate administrative infrastructure necessary to support activities of Can-ACT;
  • Describe the leadership plan and address how the components of the Coordinating Center, including key personnel, will interact within the Coordinating Center itself, with the Can-ACT investigators, the ICN Core, and NCI staff; and
  • Describe strategies for facilitating reagent and specimen sharing among the members of the Can-ACT Network.

Sub-section C: Timeline

A timeline of the initiation and completion of the aims should also be included.

Specific to this FOA

Innovation

The applicant’s plan should encourage novel collaborations among UG3/UH3 network awardees. The plan is expected to promote innovative approaches for data collection, coordination, and sharing. The plan should be strong for choosing research topics and seeking applications for supplemental awards to accelerate development and collaboration.

Approach

The approach should describe plans for sharing specimens, assay protocols, and data within the network. Describe the plan for managing the Steering Committee and the vision for the operation of that Committee. Describe the plan for encouraging intra-network collaborations, collecting applications for use of restricted collaborative funds, and presenting recommendations for use of restricted collaborative funds to NCI staff. Describe the plan for facilitating data management and harmonization of UH3 awardee clinical and correlative data, which will adhere to specified data types/formats and standards for storage, analysis, reporting, integration, sharing, and future reusability. Describe how the methods are adequately developed, well-integrated, feasible, and appropriate for data coordination and information technology to support specific Can-ACT activities.

Letters of Support: Applicants may collaborate with industry partners or academic laboratories as needed. Letters of support from these entities will be required.

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

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Investigator(s)

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

Specific to this FOA

How well will the experience of the investigator help with fostering scientific collaborations among grantees of the Can-ACT Network?

How strong is the scientific expertise that would enable managing of a Steering Committee as well as a method for shared data governance, and centralized scientific and IRB review for multisite studies?

How adequate is the experience of the applicants in creating a public-facing website? How sufficient is the scientific expertise of the team members in Immuno-Oncology/Cell-based therapies that will contribute to the successful management of the outlined activities?

Innovation

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

Specific to this FOA

How adequate is the plan for encouraging novel collaborations among UG3/UH3 network awardees?

How well is the applicant’s plan expected to promote innovative approaches for data collection, coordination, and sharing?

How strong is the plan for choosing research topics and seeking applications for supplemental awards to accelerate development and collaboration?

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA

How strong is the approach to sharing specimens, assay protocols, and data within the network?

How feasible is the plan for managing the Steering Committee and how appropriate is the vision for the operation of that Committee?

How feasible is the plan for encouraging intra-network collaborations, collecting applications for use of restricted collaborative funds, and presenting recommendations for use of restricted collaborative funds to NCI staff?

How feasible is the plan for facilitating data management and harmonization of UH3 awardee clinical and correlative data, which will adhere to specified data types/formats and standards for storage, analysis, reporting, integration, sharing, and future reusability?

How adequately developed, well-integrated, feasible, and appropriate are the methods for data coordination and information technology to support specific Can-ACT activities?

Environment

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

Specific to this FOA

How optimal are the applicant’s institutional resources for supporting the goals of Can-ACT?

To what extent will these environment(s) help respond to the needs of Can-ACT?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

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 (GDS).

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 will receive a written critique.

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

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

Applications will be assigned 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 recipient's business official.

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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

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

PD(s)/PI(s) Responsibilities

  • Providing logistic infrastructure to support the activities of the network recipients and the Steering Committee, which will include voting representation from all UG3/UH3 recipients, U24 recipient, and NCI Program and Scientific Officers, as well as non-voting members from supplemental P30/P50 recipients and the ICN Core;
  • Scheduling and coordinating monthly (virtual) and annual (in person, if possible) Steering Committee meetings;
  • Working with the UG3/UH3 recipients to facilitate collaboration between the recipients including sharing of information, reagents, specimens, and data;
  • In conjunction with Can-ACT members, establishing and implementing a plan to manage and harmonize clinical and correlative data from each member site, that will adhere to specified data types/formats and standards for storage, analysis, reporting, integration, sharing, and future reusability;
  • Creating a public-facing website for the network;
  • Identifying area of research needs for administrative supplemental funding;
  • Serving as a voting member on the Can-ACT Steering Committee;
  • Adhering to the Steering Committee recommendations and policies (to the extent consistent with applicable NIH policies) to ensure that the goals of the network are accomplished;
  • Coordinating with and leveraging, where feasible, the technology of The NCI Cancer Research Data Commons (cbiit.cancer.gov/cancerdatacommons), a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact;
  • Developing and implementing a governance policy for shared data;
  • Working with, cooperatively interacting with, and actively seeking input from NCI Project Scientists; and
  • Participating in NCI-coordinated evaluation of the Can-ACT program.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. Developing and implementing a governance policy for shared data will be the responsibility of the U24 Coordinating Center.

NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Scientist(s), will coordinate in a centralized fashion various activities of the recipients. Specific responsibilities of the NCI Project Scientist(s) will include, but will not be limited to:

  • Participating in the development and evaluation of trans-network activities;
  • Assisting in avoiding unwarranted duplications of effort across the network;
  • Providing scientific and technical input and advice as needed to the Coordinating Center;
  • Organizing review of the Administrative Supplements;
  • Working directly with the recipient to facilitate interactions with and use of the ICN Core;
  • Promoting and helping to coordinate efforts with other NIH-sponsored programs;
  • Helping coordinate collaborative research efforts that involve multiple recipients including approving restricted supplemental funding to UG3/UH3 recipients for collaborative activities;
  • Attending Can-ACT Steering Committee meetings; and
  • Assisting the network recipients as a liaison in stimulating their broader interactions with other NCI and NIH programs to disseminate results and outcomes and effectively leverage existing NIH/NCI resources and infrastructures (e.g., databases).

Additionally, an NCI Program Director acting as a Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NCI reserves the right to terminate the award in the event of deficiencies in scientific coordination and administrative support as proposed in the application.

Areas of Joint Responsibility

Steering Committee

The Can-ACT Steering Committee will serve as the initiative’s main governing board of the Can-ACT. The Steering Committee will be jointly established by the PDs/PIs from each UG3/UH3 recipient site, the PD/PI from the Can-ACT-U24 Coordinating Center, a representative of the ICN Core, and NCI-designated staff members. The Can-ACT Steering Committee will provide strategic coordination for cross-site activities. The Steering Committee will hold monthly meetings to share ongoing work, discuss current challenges, provide overall advice on future research directions, and foster the exchange of ideas, data, and collaborations across the Network.

Voting members of the Can-ACT Steering Committee will include:

  • One representative from each UG3/UH3 project award (a PD/PI or a designated senior investigator) who will have one vote;
  • One representative from the U24 (a PD/PI or a designated senior investigator) who will have one vote; and
  • NCI Program Officers and Project Scientists will have voting privileges. The ratio of NIH Project Scientists’ votes to recipient votes will be adjusted to ensure the ratio does not exceed 1:3.

Non-voting members of the Can-ACT Steering Committee will include a representative of the ICN Core. The Can-ACT Steering Committee may decide to add non-voting members as needed, e.g., associate members, patient advocates, and/or scientific experts.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

  • Recommending research topics to be solicited by the U24 site for the eventual awarding of administrative supplements;
  • Encouraging the use of the ICN Core;
  • Encouraging and fostering collaboration and research data sharing among network members;
  • Evaluating progress at network sites and making recommendations to NCI officials for expanding or reducing areas of research focus;
  • Providing overall guidance for the use and further development of the ICN Core;
  • Providing guidance to NCI regarding the use of supplemental funds;
  • Establishing network policies and procedures;
  • Establishing policies and procedures for collaborative projects, and protocols;
  • Advising the Coordinating Center regarding the formulation of policies and procedures for data management, harmonization, and sharing;
  • Identifying impediments to success and implementing strategies to overcome them;
  • Identifying opportunities for sharing techniques, materials, information, and tools;
  • Ensuring the Can-ACT leverages existing NIH resources and programs;
  • Evaluating collaborative activities, and providing feedback to the NCI Program Staff; and
  • Serving as a hub for a broader outreach to the entire extramural research community investigating adaptive cell therapies in solid tumors

The Steering Committee may decide to establish subcommittees for specific purposes. The NCI Project Scientists and Program Officers may serve on such sub-committees, as they deem appropriate.

The Steering Committee will formulate strategic decisions and policies for Network-wide activities. The Can-ACT recipients will be required to accept and implement these decisions and policies to the extent consistent with applicable grant regulations. All SC scientific and policy decisions and recommendations that require voting will be based on a majority vote. The Can-ACT Steering Committee will be constituted at the initial Can-ACT meeting and will meet regularly (monthly or quarterly), including at least once in-person during the annual Can-ACT Investigators Meeting. The chairperson of the Can-ACT Steering Committee will be elected from the representatives of all recipients and is responsible for coordinating the Can-ACT activities with U24 Can-ACT Coordinating Center. The Steering Committee may also choose to replace the Can-ACT Steering Committee chairperson at any time based on poor job performance or failure to follow the relevant procedures and guidelines.

Dispute Resolution:

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

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Kasia Bourcier, Ph.D.
National Cancer Institute (NCI)
Telephone: 202-657-7589
Email: bourcierkd@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)

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@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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