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
Pancreatic Ductal Adenocarcinoma Stromal Reprogramming Consortium Coordinating and Data Management Center (PSRC CDMC) (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

  • August 05, 2021 - Pre-Application Webinar for the "PDAC Stromal Reprograming Consortium (PSRC)": RFA-CA-21-041 and RFA-CA-21-042. See Notice NOT-CA-21-106.

Funding Opportunity Announcement (FOA) Number
RFA-CA-21-042
Companion Funding Opportunity
RFA-CA-21-041 , U01 Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.394, 93.395
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is associated with the U01 PDAC Stromal Reprogramming Consortium (PSRC) RFA-CA-21-041.The purpose of this FOA is to create a U24 Coordinating and Data Management Center (CDMC) that will support the overall coordination and research aims of the PSRC Research Projects. This FOA solicits U24 cooperative agreement applications from appropriate multidisciplinary groups that can assemble the appropriate infrastructure to facilitate and implement the administrative, outreach, collaborative and data management activities of the PSRC.

Key Dates

Posted Date
July 26, 2021
Open Date (Earliest Submission Date)
October 01, 2021
Letter of Intent Due Date(s)

30 days prior to the 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
November 01, 2021 Not Applicable Not Applicable March 2022 May 2022 July 2022

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

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

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

Expiration Date
November 02, 2021
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

The purpose of this Funding Opportunity Announcement (FOA) is to create a U24 Coordinating and Data Management Center (CDMC) that will support the overall network coordination and advance multidisciplinary basic/mechanistic biology and preclinical/translational research of the U01 PDAC Stromal Reprogramming Consortium (PSRC) (RFA-CA-21-041). The U24 CDMC will help to integrate, manage, and coordinate the activities and basic/mechanistic and preclinical/translational research initiatives of the PSRC, as well as facilitate collaborations with closely aligned NCI-sponsored programs and resources.

The CDMC will be responsible for many administrative, outreach, collaborative, and data management activities as it optimizes the functionality of the PSRC (see “Key Requirements of the PSRC CDMC”). The primary goal of the CDMC is to assist the PSRC to function as a thriving collaborative network by facilitating cross-network research efforts, coordinating pilot projects, and completing network-wide analyses and reports. The CDMC will facilitate the implementation of network-specific cross-cutting working groups dedicated to addressing trans-PSRC areas of importance in achieving its research goals. In conjunction with PSRC investigators, the CDMC will provide assistance with bi-directional bridging between basic, preclinical, and clinical science through collaborating with and leveraging closely aligned NCI-sponsored programs and resources. The CDMC will provide data management and analytical assistance to best support the needs of PSRC investigators and the network’s research aims. The CDMC will develop outreach opportunities to promote the exchange of scientific outcomes both within PSRC and between PSRC and the public through online portals, patient advocacy initiatives, sharing of PSRC data and resources, and feasible use of social media tools.

Background

The CDMC is intended to be in service to the PSRC. The overarching objectives of PSRC are to build upon and expand PDAC research to study tumor progression, recurrence and resistance to therapies through comprehensive tumor-tumor microenvironmental testing and evaluation of underrepresented, emerging, and non-classical mechanisms of PDAC progression and recurrence/resistance through a network of U01 Research Projects.

A primary goal of the PSRC (RFA-CA-21-041) is to develop a comprehensive understanding of PDAC tumor progression, its microenvironment (TME) as a tumor fate determinant and the reciprocal tumor-TME interactions that drive clinical outcomes. The information obtained through these comprehensive studies should expose new biology-backed vulnerabilities that will inform the development and preclinical testing of novel interventions in PDAC. Central to the PSRC structural organization is the implementation of multidisciplinary team science approaches that iteratively bridge basic and translational research across the tumor-TME continuum in each Research Project, in trans-PSRC activities, and in collaboration with other NCI-funded mechanisms and programs whenever possible.

It is anticipated that the research projects and resource cores of the individual PSRC U01 Research Projects will generate data, unique biospecimens, resources, models, and technologies that require a dedicated CDMC to centralize, integrate, and manage inter- and intra-network data, material, and know-how exchange. The PSRC CDMC will function as a coordinating intermediary across the network as a whole and facilitate liaisons between PSRC Research Projects, NCI staff, and the cancer research community.

The principal functions of the PSRC CDMC are to: 1) facilitate the integration of the multicomponent PSRC activities and communications; 2) support and enhance collective PSRC findings; and 3) accelerate iteration of discoveries between basic/mechanistic and preclinical/translational cancer research. It is envisioned that the PSRC CDMC will have national leadership and impact in addressing unmet needs to facilitate PDAC progression and therapy resistance research.

PSRC activities to be supported include, but are not limited to:

  • Facilitating communication and meeting coordination (e.g., steering committee, topical interest groups, collaboration meetings);
  • Assisting and building accessibility to infrastructure, technology, and support platforms for multimodal data management and integration;
  • Providing statistical and computational support for analysis and comprehension of data;
  • Establishing guidelines for rigor, standards, harmonization, and interoperability of data;
  • Serving as an outreach vehicle to interface with NCI staff and the larger basic and translational cancer research community; and
  • Assisting in the NCI’s productivity evaluation of the PSRC.

Key Requirements of the PSRC CDMC

The U24 PSRC CDMC will function as a crucial scientific and logistic infrastructure component of the PSRC. The main responsibilities of the CDMC will be to:

 

A. Provide a centralized administrative infrastructure to support and coordinate the activities of the U01 research projects, which includes administrative, organizational, analytical, and collaborative support for basic, preclinical, and clinical cancer research studies;

B. Facilitate and strengthen collaborations within the PSRC, and promote PSRC interaction and collaboration with NCI-sponsored programs and resources;

C. Provide multidisciplinary analytic expertise and application of statistical and computational tools in support of U01 research projects and collaborative research activities when appropriate;

D. Develop improved data integration and management methods to enhance PSRC research capacity;

E. Ensure PSRC compliance with NIH and NCI regulatory, data and resource sharing, and publication policies;

F. Assist the PSRC to identify and develop collaborative opportunities which encourage and promote bi-directional bridging between basic, preclinical, and clinical science;

G. Develop outreach activities to promote the exchange of scientific outcomes both within PSRC and between PSRC and the public; and

H. Facilitate the implementation, management, and coordination of PSRC Steering Committee and specific working groups.

The PSRC CDMC must have expertise and capabilities in information technology, study design, data management, protocol development, and logistical support. CDMC activities include (but are not limited to):

I. Network coordination and collaboration

  • Provide logistical and administrative assistance in arranging PSRC Steering Committee and working group meetings, conference calls, workshops, 1 to 2 annual meetings, and site visits when applicable;
  • Prepare documents and provide recordkeeping for the PSRC;
  • Develop and maintain a PSRC intranet, as well as, a forward-facing central web portal;
  • Implement a Network-wide data and resource sharing infrastructure that conforms to federal regulations and the policies and guidance of NIH/NCI;
  • Manage and support development, coordination, implementation, and conduct of PSRC collaborative research and pilot projects;
  • Promote the exchange of PSRC scientific outcomes within and external to the PSRC for the dissemination of PSRC-generated information;
  • Identify opportunities for patient advocacy and PSRC collaborations to promote the exchange of scientific outcomes and to identify research gaps that significantly impact underserved populations; and
  • Determine the feasibility and use of social media tools to highlight PSRC research and activities.

II. Data Management and Analytical support. The PSRC CDMC, under the direction of the PSRC and NCI program staff will work to:

  • Coordinate with PSRC awardees and the NCI Center for Biomedical Informatics & Information Technology(CBIIT) team to deposit underlying primary data for PSRC publications into an appropriate data repository, under the NCI Cancer Research Data Commons;
  • Assist in quality assurance for a central database and distribution of specimens stored at sites participating in the PSRC;
  • Support the formation and distribution of PSRC biospecimen sets and analyze data that result from the use of these specimens;
  • Provide a mechanism for rapid and routine transmittal of data, documents, and materials among the PSRC Research Projects and the NCI Program staff;
  • Develop and implement standard procedures for data collection, storage, and sharing;
  • Develop instruction manuals for data collection;
  • Resolve data errors;
  • Design interfacing modules with commercially available software to support discovery related research activities;
  • If requested by PSRC Research projects, provide statistical support and computational analysis;
  • Pre-processing of high dimensional data deriving from proteomic-, genomic-, epigenomic-, and metabolomic-based assays;
  • Development/application of bioinformatic and analytical tools for analyzing expression data (from RNA or protein array expression) with respect to biologic or clinical endpoints;
  • Develop and conduct CDMC research/data project(s) and/or analyses in conjunction with relevant PSRC Research Projects to identify Network-wide and/or cross-cutting commonalities in science, approach, or proof of concept; and
  • Perform data harmonization, formatting of data sets, and requested data analysis across PSRC Research Projects.

III. Basic and translational and clinical research expertise. The PSRC should traverse the bridge between basic, preclinical, and clinical science in a bi-directional manner to address PDAC tumor-TME dynamics that impact clinical outcomes. In support of this goal, the CDMC should:

  • Connect PSRC investigators with NCI resources/expertise in basic or clinical study design and protocol development;
  • Utilize clinical experience, concepts, and data to inform basic and preclinical experimental designs (and vice versa);
  • Identify opportunities to assist the PSRC in strengthening the bi-directional, iterative process of basic-to-preclinical-to-clinical translation;
  • Identify opportunities for new basic and clinical directions of PSRC research;
  • Facilitate meetings between basic scientists and clinical research investigators to identify and address major challenges in patient treatment lacking strong basic biological understanding; and
  • Demonstrate the ability to develop a strategic plan to engage pharmaceutical/biotechnology companies interested in PSRC research projects and/or translation of the scientific outcomes into clinical trials.

Coordination of the PSRC

Given the complex nature and structure of the multi-PI (U01s) and CDMC (U24), NCI program staff will be substantially involved in the PSRC and CDMC. NCI program staff will monitor the scientific progress of PSRC Research Projects, participate in monthly steering committee meetings for sharing pre-published data, provide direction in data management activities, and ensure that restricted funds are effectively used for productive trans-U01 collaborative projects. NCI program staff will assist in identifying and prioritizing areas of common interests and/or challenges across the PSRC, and with the CDMC, facilitate the implementation of network-specific cross-cutting working groups.

The CDMC will coordinate with the PSRC Steering Committee and Co-Chairs to provide leadership and be actively involved in decisions regarding the Consortium. Details on the Administrative and National Policy Requirements and Cooperative Agreement Terms and Conditions of Award are provided in Section VI.2.

The PSRC CDMC will be responsible for developing an overarching PSRC progress report that highlights the U01 Research Projects and trans-PSRC activities for the entire Consortium starting in year 2 of the award’s project period, and then cumulatively updated in years 3, 4, and 5.

NCI Resources to Support the PSRC

The PSRC is encouraged to collaborate with and leverage closely aligned NCI-sponsored programs and resources to help in the bi-directional bridging between basic, preclinical, and clinical science. The CDMC will assist the PSRC in identifying and facilitating collaborations with NCI-sponsored programs and resources, including but not limited to the Experimental Therapeutics Clinical Trials Network (ETCTN), National Clinical Trials Network (NCTN), NCI Cancer Therapy Evaluation Program (CTEP) agents, Pharmacodynamic Assay Development and Implementation Section (PADIS), Patient-Derived Xenograft Development and Trial Centers Research Network (PDXNet), Cancer Systems Biology Consortium (CSBC), Physical Sciences Oncology Centers Network (PSON), Patient -Derived Models of Cancer (PDMC), Radiation Oncology Biology Integration Network (ROBIN), Acquired Resistance to Therapy Network (ARTNet), Human Tumor Atlases Network (HTAN) and Specialized Programs of Research Excellence (SPOREs).

Further NCI resources include investigational agents in NCI’s IND agents portfolio or the NCI Formulary agents portfolio for preclinical studies available with a Material Transfer Agreement (MTA); patient-derived xenograft models developed by NCI investigators at the Frederick National Laboratory for Cancer Research; and in some cases patient bio-specimens acquired before and/or after drug treatment in NCI clinical trials. Biomarker assay procedures developed by the PADIS laboratories may also be leveraged.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI intends to fund one (1) Coordinating and Data Management Center award, not to exceed a total cost of $990,000 for fiscal year 2022. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets must reflect the actual needs of the proposed project but must not exceed $600,000 per year in direct costs.

Award Project Period

Applicants may request up to 5 years of support.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

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

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

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

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

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:

Peter Ujhazy, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5686
Email: pu5s@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.

R&R Budget

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

Each individual designated as a PD/PI must commit a minimum of 1.8 person-months of effort per year. This minimal effort level must be maintained throughout the entire project period.

Funds for travel. The PSRC CDMC PD(s)/PI(s) are required to travel to face-to-face PSRC meetings per year (one or two). Include travel funds for two to four representatives from the PSRC CDMC (at least one of whom must be the PSRC CDMC PD/PI). Travel costs for one to two presenters for one major national meeting may be included in the budget.

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: List Specific Aims for the proposed Coordinating Data and Management Center (CDMC)

Research Strategy: Instead of standard sub-sections, the Research Strategy must consist of the following sub-sections A through D. In these sub-sections, provide a narrative describing plans to meet the following CDMC requirements:

Sub-section A. Overall Vision of the Proposed CDMC

  • Provide a centralized administrative infrastructure to coordinate PSRC activities, which includes organizational, biostatistical, data curation, and collaborative support for basic and translational acquired resistance to cancer therapy research studies;
  • Ability to support PSRC administrative activities including, but not limited to, monitoring and coordinating the joint activities of multi-site projects, preparing reports, managing logistics, scheduling and preparing for group meetings and site visits, and dissemination of outcomes from multi-institutional studies;
  • Ensure PSRC compliance with NIH and NCI policies and requirements, and federal government regulations;
  • Facilitate and promote multi-institutional, trans-disciplinary research efforts through scientific and organizational support with emphasis on efficient communications, coordination of efforts, data integration, and trans-consortium and inter-institutional scientific collaborations (within the PSRC, as well as, between PSRC investigators and external NCI-funded researchers and networks).
  • Demonstrate that the team has expertise in proteomics, clinical research, unmet clinical needs, clinical trials and with access to trial samples; and
  • Demonstrate that the team has expertise in other disciplines, such as genomics, cancer biology, molecular oncology, clinical oncology, biostatistics, experimental design, bioinformatics, and clinical laboratory science/clinical chemistry.

The description must include the following specific aspects:

  • The scientific vision of the proposed CDMC;
  • Major strengths and experience of the research team particularly in coordinating multi-disciplinary and multi-institutional programs (explain collective strengths without repeating information in individual biosketches);
  • Innovative aspects of the CDMC and its potential for coordinating the trans-disciplinary research conducted through the entire PSRC;
  • Demonstrated level of competency in coordinating the collection, analysis, harmonization, and sharing of trans-disciplinary or multi-scale data;
  • Demonstrated expertise and capabilities in biostatistics, information technology, study design, data management, protocol development, and logistical support;
  • Description of translational experience of the proposed CDMC in traversing the bridge between basic, preclinical, and clinical science; and
  • Computational, bioinformatics and biostatistical capabilities/resources and associated experience in coordinating large NIH-funded programs.

Sub-section B. Leadership and Administration Unit

  • Support the development and coordination of trans-PSRC collaborative research projects;
  • Promote and facilitate interactions between the PSRC and NCI scientific staff to allow for efficient interactions, consultations, and oversight function;
  • Provide logistical and administrative assistance in arranging large scale meetings, conference calls, and face-to-face meetings;
  • Provide logistical, administrative, and regulatory/agreement support for PSRC Steering Committee activities and its subcommittee(s)/working groups in coordination with NCI regulatory staff;
  • Demonstrate considerable experience in leading collaborative, multidisciplinary research and development.
  • Provide recordkeeping for the PSRC;
  • Implement a network-wide data and resource sharing infrastructure that conforms to the data sharing and resource sharing policies of the NIH and NCI;
  • Develop and implement education and outreach tools to disseminate PSRC research results across multiple venues; and
  • Develop and maintain a PSRC intranet, as well as, a forward-facing central web portal.

The description must include the following specific aspects:

  • The organization of the CDMC leadership structure;
  • Management and facilitation plan for PSRC activities, including collaborations, U01 pilot projects, administrative site visits, and Steering Committee meetings, workshops and conferences;
  • Monitoring plan to ensure data sharing among all PSRC participating sites;
  • Coordinate when necessary the development of a strategic plan to engage pharmaceutical/biotechnology companies interested in collaborating in PSRC basic and preclinical research projects and/or translation of PSRC scientific outcomes into clinical trials;
  • Integration plan to describe the approach to standardize and harmonize PSRC data;
  • Dissemination plan to distribute data/tools/resources to the greater research community and outcomes to both the research and public communities at large; and
  • PD/PI experience in coordinating, managing, and directing a large multi-disciplinary team.

Sub-section C. Virtual Resource Repository Unit

  • Track PSRC U01s' activities and accomplishments within the overarching goals of cross-utilization of unique research resources;
  • Establish and operate a harmonized centralized data collection, management, analysis, and dissemination unit for the entire network to support a virtual biorepository. This biorepository includes the capacity for setting-up a registry database that collects information on all available non-standard tools. They may also collect clinical, demographic, and molecular information of patient samples to be used in the PSRC program, including information on the availability of biological specimens at all participating sites (including archived specimens). The biospecimen data must include information about the regulatory approvals of specimen collections and the level of informed consent. This Virtual Resource Repository Unit needs to harmonize data collections with the NCI Cancer Research Data Commons described below; and
  • Establish specimen and data catalogs to access procedures that would allow for efficient sharing of specimens and data for collaborative research studies across the PSRC as well as with outside investigators as appropriate and consistent with achieving the goals of the program. The procedures should address the process for review and approval of applications submitted to access the specimens and/or data. The procedures should describe the tracking and distribution of available specimens to investigators, consistent with achieving the goals of the program.

Sub-Section D. Data Management and Analytical Support

  • Coordinate with PSRC awardees and the NCI Center for Biomedical Informatics & Information Technology(CBIIT) team to deposit the underlying primary data for PSRC publications into an appropriate data repository, under the NCI Cancer Research Data Commons;
  • Provide multidisciplinary analytic expertise and application of statistical and computational tools to support PSRC studies and collaborative research;
  • Assist in data harmonization, quality assurance for a central database, and distribution of specimens stored at sites participating in the PSRC;
  • Support the formation and distribution of PSRC biospecimen sets and analyze data that result from the use of these specimens;
  • Provide a mechanism for rapid and routine transmittal of data-related materials among the PSRC participants and the NCI Program staff;
  • Develop instruction manuals for data collection and resolve data errors;
  • Develop standard procedures for data collection, storage, and sharing by the PSRC;
  • Perform data harmonization, formatting of data sets, and requested data analysis across the PSRC Research Projects;
  • Pre-processing high-dimensional data; and
  • Analyzing expression data.

The description must include the following specific aspects:

  • The process for developing standard procedures for data collection, storage, and sharing;
  • Experience designing interfacing modules with commercially available software necessary to support discovery related research activities;
  • Experience pre-processing high dimensional data deriving from multi-omic assays; and
  • Experience developing/applying bioinformatic and analytical tools for analyzing expression data (from RNA or protein array expression) with respect to biologic or clinical endpoints.

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 include and address a Resource Sharing Plan as defined below.
  • A Resource Sharing Plan for data (including genomic data), unique materials (including biological materials such as patient-derived cells, organoids and tissues), tools, model organisms, reagents and therapeutics, along with IP and knowhow management must be provided by each PSRC U01 Research Project application and must cover all the activities proposed for the PSRC U01 Research Project and within the context of the PSRC Program, where applicable.
  • The Resource Sharing Plan should briefly describe the types of data and computational resources and unique biological resources that are expected to be generated and shared, consistent with achieving the goals of the PSRC Program;
  • Resource Sharing Plans are expected to describe plans for anonymization, annotation, multimodal data integration; harmonization; transfer learning; development of robust statistical-, Artificial Intelligence-, and/or Machine Learning-ready datasets to facilitate formats that are accessible to increase the value of these data and unique resources for sharing with the scientific community and the PSRC;
  • Note that NCI Program staff may negotiate modifications to these plans prior to funding. Specifically, applicants will be expected to abide by the policies and procedures for unique resources and data, software, and computational model sharing within the context of the NCI Cancer Data Ecosystem including infrastructure and resources for access of multi-modal data, elastic computation, and analysis through the Cancer Research Data Commons developed upon availability (see Section VI: Terms and Conditions of Cooperative Agreement); and
  • Formats, analytical algorithms, computational modeling and visualizations, and other bioinformatics tools resulting from this FOA are expected to be compatible with the NIH-approved bioinformatics platforms, such as those designed and implemented by the NCI Center for Bioinformatics platforms (https://cbiit.cancer.gov/data-sharing).
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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, 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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Are the available research infrastructure, programs, scientific expertise, and collaborations adequate to support the PSRC Research Projects?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: Does the applicant team have experience overseeing selection and management of sub-awards, if needed? Does the CDMC team have the appropriate capabilities to support proposed projects and data sharing among all PSRC participating sites? Are plans to facilitate data and resource sharing across the Network compatible with the PSRC Research Projects’ capabilities? Does the administration infrastructure demonstrate the capacity of the PSRC CDMC to collaborate with the PSRC Research Projects and NCI program staff on scientific progress, peer-reviewed publications, web sites, evidence-based dissemination, or new collaborations and partnerships? Is there adequate evidence of the managerial and collaborative capabilities of the proposed CDMC leadership? Is the leadership structure of the proposed Coordinating Center in terms of (a) the overall goals of the PSRC program; (b) the coordination of multiple institutions participating in the PSRC Research Projects; and (c) understanding and familiarity with the state of the science in this field of research appropriate?

Innovation

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

Specific to this FOA: Does the applicant propose novel organizational concepts in coordinating and supporting the PSRC? Are the tools proposed to undertake trans-Consortium analyses of data appropriate? Will the applicant’s proposal to facilitate meetings between basic scientists and clinical research investigators identify and address major challenges in basic and translational research that may inform and impact patient treatment effectively? Will the proposed CDMC identify and develop research/data project(s) and/or analyses that it can accomplish? Will the proposed CDMC facilitate the identification of Consortium-wide and/or cross-cutting analyses to uncover commonalities in science, approach, or proof of concept?

Approach

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

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 adequate are the Resource Sharing Plans for the sharing and dissemination of data, model organisms, human and non-human specimens, tools, reagents, therapeutics, genomic data, intellectual property, know-how and proprietary techniques and inventions within and outside the institution, especially with other members of the PSRC? How much freedom to operate is granted to PSRC members to utilize, without restrictions other than by law(s) or regulation(s) said Resources for non-commercial purposes directly related to the PSRC activities and goals?

Environment

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

Specific to this FOA:

Coordinating Data and Management Center (CDMC)

Are the environment and associated capabilities of the proposed CDMC conducive for the implementation of the overall strategy, operational plan, and organizational structure? Is the plan well-reasoned and appropriate to accomplish the goals of the PSRC? Does the level of translational experience of the proposed CDMC demonstrate the ability to traverse the bridge between basic, preclinical, and clinical science?

Is the proposed CDMC’s approach to integrate and harmonize data adequate? Is the plan to disseminate tools/resources to the greater NIH community and public appropriate? Will the CDMC be able to effectively facilitate and promote collaborations within PSRC and between PSRC and NCI resources/programs using the plan proposed? Is the plan to coordinate PSRC pilot projects reasonable and have the potential to be successful? Are the CDMC’s plans to facilitate meetings adequate?

Virtual Resource Repository Unit

How appropriate and well justified are the proposed plans to create the Virtual Resource Repository? Does the CDMC have the capacity for establishing a database that collects information on all available analytic and technological tools, procedures, protocols and patient samples to be used in the studies conducted by the PSRC and all participating sites? How appropriate are safeguards for privacy and confidentiality protections of identifiable data? How adequate and efficient is the plan to support the sharing of unique tools, technologies, specimens and information across the PSRC and with extramural collaborating investigators? How adequate is the plan to enable the tracking and distribution of available non-standard materials, protocols, technologies, reagents and new and/or archived specimens to investigators?

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 Resource Sharing Plans are reasonable.

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of the 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 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 reside with the recipients for the project, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Determining the CDMC's scientific directions and its goals;
  • Determining and coordinating research approaches and procedures for the collection and analyses of research and specimen data from the PSRC Research Projects;
  • Facilitating the organization of PSRC annual meetings, working groups and teleconferences as needed to include, but is not limited to organizing the annual PSRC Steering Committee meeting (in collaboration with NCI project scientists), scheduling periodic conference calls for the PSRC Research Projects, participating in the annual PSRC Steering Committee meeting and periodic conferences, implementing all scientific and practical decisions approved by the PSRC Steering Committee, and assisting the Steering Committee in assembling appropriate panels such as a subcommittee of experts to advise the Steering Committee;
  • Providing scientific and technical assistance and advice to the recipients as appropriate, serving as scientific collaborators when appropriate;
  • Managing and executing data and material transfer agreement with review and coordination by the NCI;
  • Avoiding unwarranted duplication efforts with other projects funded within the PSRC;
  • Overseeing the timely release and sharing of specimens and data from the program participating in the development and evaluation of cross-PSRC collaborations with NCI staff and non-PSRC collaborators;
  • Leveraging, where feasible, technology from related NCI-sponsored informatics initiatives, for example, The NCI Informatics Technology for Cancer Research (ITCR (https://itcr.nci.nih.gov/)) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research;
  • Coordinating with and leveraging, where feasible, the technology of The NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact (cbiit.cancer.gov/cancerdatacommons);
  • Facilitating standard annual Research Performance Progress Report (RPPR) submissions, supplying additional progress-related information as needed;
  • Preparing for administrative site visits by NCI staff members;
  • Designing interfacing modules with commercially available software at the request of the NCI PSRC Program Official;
  • PSRC CDMC and NCI will meet annually with PSRC Research Projects to help coordinate the sharing of data, research resources, tools/platforms, and addressing challenges to access biorepositories;
  • Providing a mechanism for rapid and routine (to be determined by the PSRC Steering Committee in coordination with NCI Program staff) transmittal of materials (e.g., computer output, reports, etc.) among the PSRC participants and the NCI Program staff;
  • Facilitating the cross-PSRC development and selection of PSRC collaborative projects for review and approval by NCI staff. Develop procedures for soliciting and evaluating ideas for trans-PSRC collaborative projects as well as criteria for their prioritization;
  • Facilitating PSRC Research Project activities to assure compliance with federal regulations and NIH and NCI policies; and
  • Facilitating entry of various PSRC data sets into NIH/NCI repositories to share and extend scientific findings.

The following additional responsibilities will apply for the CDMC recipient:

  • The CDMC and the entire PSRC will be subject to periodic performance evaluation (coordinated by the PSRC Steering Committee Chair) and external evaluation (coordinated by the NCI). PSRC recipients will be expected to participate in such evaluations.
  • The CDMC is encouraged to share with the PSRC knowledge, specimens, data, research materials, and any other resources as appropriate.
  • Prior to the initiation of work under this funding agreement, the NCI, the CDMC and entire PSRC shall enter into a Research Collaboration Agreement that shall govern, Intellectual Property, the exchange of data and materials within the Network, and publications.
  • The PSRC CDMC recipient will be responsible for monitoring implementation and maintenance of each PSRC Research project's NIH Genomic Data Sharing Policy. The CDMC will facilitate dbGAP registration for PSRC Research Project studies by assuring that a completed, most current Basic Study Information (BSI) form and an Institutional Certification (IC) is received from the appropriate PSRC Research Project for dbGAP registration of any study performing molecular characterization or genetic analysis. The CDMC will send both the BSI and IC to the NCI Cancer Therapy Evaluation Program Genomic Program Administrator for dbGAP registration of the study.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, within the limits of any accepted binding NCI/NIH collaborative agreements with biotechnology and pharmaceutical partners and as governed by NCI-approved Data Sharing Plans and NCI-approved review for use of biospecimens collected in association with PSRC. Custody of and primary rights to the data and software developed under these awards is subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. The NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data. They may have primary rights in data but there may be restrictions based on binding collaborative agreements that provided specimens.

The CTEP Intellectual Property (IP) Option applies to all PSRC Research Projects and PSRC CDMC projects, regardless of the sponsor. Inventions conceived, as defined under United States patent law, or actually reduced to practice in performance of the Research Project under the applicable HMTA shall be managed in accordance with the terms of the CTEP IP Option, which can be found at:

The Terms and Conditions of Award for all the Cooperative Agreements under the PSRC define the operational principles under which the recipients must function to ensure the independence of the research conducted regardless of whether program income is or is not available for any of the awards. All key components of the PSRC must report “Program Income” to the NCI on an annual basis (in the non-competitive Type 5 application (Research Performance Progress Report (RPPR)) and must indicate the research study that the funds are being used to support (or other functional component if the funds are not provided to support specific studies).

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NCI Program staff member(s) acting as a Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement.

Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Some Program Officials may also have substantial programmatic involvement (as Project Scientists/Coordinators).

The specific roles of the substantially involved NCI staff members include the following activities:

  • Assisting in avoiding unwarranted duplications of effort across the PSRC;
  • Helping coordinate collaborative research efforts that involve multiple PSRC Research Projects;
  • Monitoring the operations of the PSRC Research Projects and making recommendations on overall project directions and allocations of funds;
  • Reviewing the progress and making yearly funding recommendations of individual PSRC Research Projects and of specific activities shared among the Research Projects and CDMC;
  • Participating in the development, evaluation, funding recommendations and approval of cross-PSRC Projects;
  • Providing review and approval for cross-PSRC collaborative projects and release of restricted funds to support these projects;
  • Co-organizing and participating in PSRC Steering Committee and face-to-face meetings;
  • Assisting the PSRC recipients as a liaison in stimulating broader interactions with other NCI and NIH programs to disseminate results and outcomes, and effectively leverage existing NIH/NCI resources and infrastructures;
  • Evaluating the adherence of PSRC recipients to the approved data and resource sharing plans; and
  • Conducting PSRC administrative site visits, if needed.

Areas of Joint Responsibilities include:

The CDMC will facilitate PSRC Steering Committee activities in conjunction with NCI Program staff. The PSRC Steering Committee will serve as the main governing board of the PSRC.

The committee will consist of the following voting members:

  • The PD(s)PI(s) of each awarded PSRC Research Project will collectively have one vote.
  • The PD/PI of the CDMC and a designated senior investigator will collectively have one vote.
  • The NCI Project Scientist(s) will collectively have one vote for the NCI.

Additional non-voting members who can serve in an advisory capacity may be added to the PSRC Steering Committee as needed by a decision of the existing voting committee members. These additional non-voting members may include other NCI and NIH Program Staff members and/or Program Staff members from other Federal agencies.

The PSRC Steering Committee, CDMC, and NCI Program staff will have the following primary responsibilities:

  • Oversee the overall PSRC program and review its research progress;
  • Review the potential of shared support infrastructure(s) at individual PSRC centers to serve the needs of other PSRC Research Projects and the entire Consortium;
  • Ensure that the PSRC Research Projects and the CDMC take advantage of existing NCI and NIH resources and programs;
  • Make recommendations for termination of projects that become unpromising or unproductive;
  • Participate in the development of the agenda for the annual PSRC Steering Committee meeting to present scientific progress and future plans from PSRC investigators;
  • Establish advisory groups as necessary to ensure the progress of individual PSRC Research Projects as well as the entire PSRC; and
  • Ensure that individual PSRC members accept and implement as appropriate actions (recommendations, directions, etc.) approved by the PSRC Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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.

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)

Peter Ujhazy, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5686
Email: pu5s@nih.gov

Jeffrey Hildesheim, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6213
Email: hildesheimj@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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, 45 CFR Part 75, and 2 CFR 200.


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