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
NCI Pediatric In Vivo Testing Program Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-CA-14-019

Related Notices

  • August 31, 2020 - Pre-Application Webinar for NCI Pediatric In Vivo Testing Program and NCI Pediatric In Vivo Testing Program Coordinating Center (RFA-CA-20-034, RFA-CA-20-041). See Notice NOT-CA-20-096.

Funding Opportunity Announcement (FOA) Number
RFA-CA-20-041
Companion Funding Opportunity

RFA-CA-20-034 - NCI Pediatric In Vivo Testing Program (U01 Clinical Trial Not Allowed)

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

93.395

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is for a Coordinating Center for the NCI Pediatric in Vivo Testing Program (henceforth termed the Ped-In Vivo-TP). The main goal for the Ped-In Vivo-TP is to use genomically-characterized pediatric cancer models to develop a rigorous preclinical testing system to generate reliable data that can be used to inform new agent prioritization decisions for childhood cancers.

The Ped-In Vivo-TP has two parts: a) research teams for in vivo testing to determine the activity of pediatric anticancer drug candidates, supported under RFA-CA-20-034; and b) a Coordinating Center (RFA-CA-20-041, this FOA).

The Ped-In Vivo-TP is envisioned as a way for NCI to support the Foundation for the National Institutes of Health (FNIH)-organized Public-Private Partnership (PPP) for pediatric preclinical testing. The PPP is being developed to accelerate the pace and to broaden the scope of pediatric preclinical testing of agents being developed for adult cancer indications. Pharmaceutical companies and representatives of regulatory agencies will also participate in the PPP.

This FOA invites applications for the Ped-In Vivo-TP Coordinating Center. The Ped-In Vivo-TP Coordinating Center will be responsible for integrating the activities of the individual Ped-In Vivo-TP Research Teams to create a functional collaboration for pediatric preclinical testing. Specifically, the Ped-In Vivo-TP Coordinating Center will be responsible for the following: 1) Administrative and logistical coordination; 2) Data management, statistical, and bioinformatics support; and 3) Scientific coordination and support.

Key Dates

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

30 days prior to the application due date

Application Due Date(s)

November 9, 2020

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

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

AIDS Application Due Date(s)

Not Applicable

 

 

Scientific Merit Review

March/April 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

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

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of the NCI Pediatric in Vivo Testing Program (Ped-In Vivo-TP) will be to generate, analyze, and disseminate preclinical data using genomically characterized in vivo models to help inform the development of new and more effective treatments for children with cancer. As such, the application is specifically designed to align with objectives of both the FNIH Public-Private Partnership (PPP) for preclinical testing as well as to contribute to the NCI Childhood Cancer Data Initiative (CCDI). As described below, the in vivo testing activities of the NCI-Ped-In Vivo-TP will be supported through an anticipated eight awards to Research Teams to plan and conduct in vivo testing (the scope of FOA RFA-20-034) and through a single award to a Coordinating Center for the in vivo testing programs (the topic of this FOA).

The Ped-In Vivo-TP research activities will complement NCI-supported childhood cancer clinical research programs. The systematic preclinical efficacy and pharmacokinetic-pharmacodynamic testing of novel agents by the Ped-In Vivo-TP Research Teams will facilitate the new agent prioritization process of pediatric oncology clinical research programs. The optimized prioritization process should increase the likelihood that agents selected for clinical trials will be efficacious, opening new therapeutic options for more effective treatments for children with cancer.

This FOA invites applications for the Ped-In Vivo-TP Coordinating Center. The Coordinating Center will be responsible for integrating the activities of the individual Ped-In Vivo-TP Research Teams (described in RFA-CA-20-034) to create a functional collaboration for pediatric preclinical testing. Specifically, the Ped-In Vivo-TP Coordinating Center will provide: 1) administrative coordination and logistical support; 2) data management and statistical and bioinformatics support; and 3) scientific coordination including project management, preparation of study reports, and coordination of manuscript preparation.

Background

Introduction. The challenges associated with developing new therapies for childhood cancers are distinctive from those encountered in developing therapies for the neoplastic diseases of adults. They have been amplified in recent years by evolving trends in drug development, particularly the subdividing of patients for clinical evaluation based on the genomic characteristics of their cancers. The thankfully relatively small number of patients with progressive disease who become eligible for clinical trials of experimental drugs places severe restrictions on the number of novel investigational agents that can be evaluated in children with specific cancers. Furthermore, new anticancer agents are being developed primarily for activity against adult neoplastic diseases (e.g. colon, lung, breast, etc.), so that agents with specific activity against childhood malignancies might not be identified. Preclinical testing programs using genomically characterized pediatric cancer models and validated testing methods can contribute by providing reliable testing results to use for agent prioritization decisions so that progress in identifying more effective treatments for children with cancer can be accelerated.

History. NCI initially supported a pediatric preclinical testing program in 2004. In its most recent iteration, the Pediatric Preclinical Testing Consortium (PPTC) has been supported through an NCI cooperative agreement mechanism (U01) since 2015. Five research teams have performed in vivo testing for the following tumor types:

  • Rhabdomyosarcoma, Ewing sarcoma, and Wilms tumor and other renal cancers;
  • Brain cancers;
  • Neuroblastoma;
  • Osteosarcoma
  • Acute lymphoblastic leukemia

The PPTC Coordinating Center has provided administrative, logistical, and statistical support. Information about the PPTC is available at the PPTC website. The PPTC statistical analysis procedures for analyzing in vivo testing results are also available at the PPTC website.

Impact of Recent Legislation. The importance of a robust pediatric preclinical testing program is heightened in the current environment by provisions of the FDA Reauthorization Act of 2017 (FDARA) that amended the Pediatric Research Equity Act (PREA) in section 505B of the Federal Food, Drug, and Cosmetic Act (FDCA) to add a new molecularly targeted pediatric investigation requirement for certain oncology medicine applications. Specifically, this requirement applies to the sponsor of an original new drug application (NDA) or biologics license application (BLA) for a new active ingredient submitted on or after August 18, 2020, if the drug is “intended for the treatment of an adult cancer” and “directed at a molecular target that [FDA] determines to be substantially relevant to the growth or progression of a pediatric cancer". If these criteria are met, the sponsor must conduct “a molecularly targeted pediatric cancer investigation designed to yield clinically meaningful pediatric study data regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling" beginning in August 2020. The FDA’s initial list of potentially relevant molecular potential pediatric targets included over 200 distinct molecular entities. Pharmaceutical company representatives estimate that as many as 200 agents per year will require some type of evaluation for their relevance to childhood cancers.

Relationship to FNIH Public-Private Partnership for Pediatric Preclinical Testing. Catalyzed by both the legislation described above and by the need to address the challenges created by the need for evaluations of large numbers of investigational agents for their relevance to childhood cancers, NCI, FDA, and the Pharmaceutical Research and Manufacturers of America (PhRMA) approached the FNIH to convene stakeholders to develop a public-private partnership (PPP) to create centralized resources for a more systematic, global, and robust approach to pediatric preclinical testing of cancer therapies. In September 2019, FNIH sponsored a meeting to discuss “Potential Preclinical Pediatric Oncology Public-Private Partnership (PPP)” that brought together representatives from pharmaceutical companies, NCI, FDA, and academia to develop a research agenda for a pediatric preclinical testing PPP. The FNIH PPP white paper (available upon request from the Scientific/Research Contact), which was based on the meeting discussions and follow-up discussions, described the following specific tasks for the PPP:

  • Creating, publishing, and continuously updating a catalogue of existing preclinical pediatric cancer models and facilitating research community access to these models;
  • Establishing and validating a high-throughput in vitro testing platform (e.g., cell lines and potentially organoids as well), and making it broadly available to stakeholders;
  • Harmonizing existing standards across models, data, response criteria, and informed consent;
  • Conducting joint target and agent feasibility analyses, similar in nature and process to the Target Actionability Reviews currently undertaken by the ITCC-P4, but encompassing data from publicly available repositories that is unpublished as well as the data generated by the testing conducted within the PPP (once appropriate exclusivity periods are met);
  • Developing new murine models through collaborative pilot studies to address the key current gaps in the field;
  • Investing in enhanced “data commons” capabilities to enable aggregation and comparison of existing and new testing data to support enhanced decision-making;
  • Establishing an ongoing forum for tracking progress and allocating new investments, the Strategic Advisory Committee (SAC);
  • Conducting testing of agents at sites established by the PPP, either CRO or academic, depending on the needs of the company providing the agent in consultation with the SAC and making results available to the broader research community (once appropriate exclusivity periods are met).

This FOA and the accompanying FOA for the Ped-In Vivo-TP Research Teams can be viewed as research programs through which NCI will be supporting the establishment of the pediatric preclinical testing PPP being developed by FNIH.

Research Objectives and Requirements

The Ped-In Vivo-TP will consist of academic research teams with expertise in the cancer types for which they are responsible for testing (see RFA-CA-20-034), and the Coordinating Center will be charged with supporting these research teams to form a comprehensive and cohesive testing program. A goal in establishing the Ped-In Vivo-TP will be for the program to broadly represent the range of cancers that occur in children. As such, for the eight awards that are anticipated for research teams performing testing, 6-7 are anticipated to have a focus on pediatric solid tumors as well as CNS tumors and 1-2 are anticipated to have a focus on pediatric leukemias (ALL and AML).

Functions of the Coordinating Center: The Coordinating Center will support the Ped-In Vivo-TP Research Teams through the following:

1) Administrative and logistical coordination support;

2) Data management, statistical, and bioinformatics support; and

3) Scientific coordination support including project management, preparation of study reports, and coordination of manuscript preparation.

The Coordinating Center will be responsible for the analysis of in vivo testing results generated by the in Vivo TPs. Testing by the in Vivo TPs is anticipated to include conventional testing designs with treated and control groups (5-10 animals in each group) and using time-to-event endpoints and response assessments based on serial tumor volume measurements. The single-mouse trial (SMT) design is also anticipated to be used as it allows a larger number of models to be studied in cost-effective way. The SMT design is relevant to agents for which tumor-regressing activity is sought and its readout is the maximum tumor volume reduction. The statistical analysis methods employed by the PPTC are available at the PPTC website. Other study designs may be used when determined to be scientifically appropriate to evaluate the activity of agents. In addition, testing of combinations of agents will be an important aspect of the Ped-In Vivo-TP and is anticipated to involve comparisons of the activity of the combination of agents to the activity of the single agents used alone.

Requirement for Model Material Transfer Agreement (MTA). Testing of agents by the Ped-In Vivo-TP will be performed under terms of a model Material Transfer Agreement (MTA). The terms of the Ped-In Vivo-TP model MTA will be similar to those of the model MTA of the PPTC. At the beginning of the awards for each Ped-In Vivo-TP research team and for the Coordinating Center, NCI will sign an MTA with each awardee's institution for the provision of agents for testing through the Ped-In Vivo-TP. For each agent identified for testing through the Ped-In Vivo-TP, NCI staff members will negotiate MTAs with the entity supplying the agent for testing such that the terms of the MTA with this entity match the terms of the MTAs that NCI has with each of the testing Ped-In Vivo-TP institutions.

Ped-In Vivo-TP Governance: The Ped-In Vivo-TP Steering Committee (SC) will serve as the body for prioritizing agents for study by the Ped-In Vivo-TP, for defining the overall scope of research plans for agents selected for testing, and for approving the general SOPs under which the Ped-In Vivo-TP operates. The SC will include: the PD(s)/PI(s) of the Ped-In Vivo-TP Coordinating Center and the PD(s)/PI(s) of each of the Ped-In Vivo-TP Research Teams, the NCI Project Scientist, and others as appropriate.

The PD(s)/PI(s) of the Ped-in Vivo-TP Coordinating Center and the PD(s)/PI(s) of each of the Ped-In Vivo-TP Research Teams will also be expected to serve on the Scientific Advisory Committee (SAC) of the FNIH PPP for pediatric preclinical testing. The Ped-In Vivo-TP SC may accept recommendations from the PPP SAC for agents to prioritize for testing within the Ped-In Vivo-TP.

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
Renewal
New

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

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

 NCI intends to commit approximately $800,000 to fund a single award in FY 2021.

Award Budget

The application budget is limited to $500,000 in direct costs per year and should reflect the actual needs of the project.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

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

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

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:

Malcolm A. Smith, MD, PhD

National Cancer Institute (NCI)
Telephone: (240) 276-6087

Email: Malcolm.Smith@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.

Other Attachments: Applicants must provide the additional supporting materials indicated below.

Upload these materials as a single PDF file using file names indicated in the list (these file names will become bookmarks in the application).

  • A template for a technical study report to be used in preparing a report of testing results for pharmaceutical collaborators (use file name "Technical Study Report").
  • Details of the analytical methods proposed to analyze in vivo data to be generated by the Ped-In Vivo-TP Research Teams. Include examples of standard graphical representations used to present in vivo testing results. Use file name "Analytical Methods".
  • A letter from an institutional official indicating that the terms that are included in the Model MTA used by the Pediatric Preclinical Testing Consortium are acceptable to the applicant's institution. Similar terms will apply for testing of agents through the Ped-In Vivo-TP.
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.

Travel: Applicants are required to include travel support for an investigator from their research team to attend an annual face-to-face meeting. In the budget, a travel budget for one trip per year to these meetings must be included.

Publication costs: Applicants are required to include anticipated publication charges for Ped-InVivo-TP publications.

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:

Research Strategy: Specific Sub-Sections A-D that must be included in Research Strategy are described below.

Sub-section A. Comparable Experience Description (for New Applications) / Progress Report (for Renewal Applications)

  •   For new applications, describe experience serving in a Coordinating Center role for an activity of comparable size and scope as the proposed Ped-In Vivo-TP without duplicating information in biosketches
  • For renewal applications, follow PHS 398 instructions for inclusion of a Progress Report.

Sub-section B. Administrative Coordination and Logistical Support

Describe the proposed approach to the following administrative and logistical responsibilities:

  • Overall approach to the administrative management, logistics, and coordination of multiple sites performing in vivo testing, including management of Steering Committee (SC) activities;
  • Establishment and maintenance of a web-based collaboration system for enhanced communication that includes the capability for secure sharing of documents and data and that provides tiered access based on role to relevant Ped-In Vivo-TP personnel (e.g., PD(s)/PI(s) and staff of the Ped-In Vivo-TP, pharmaceutical collaborators, etc.);
  • Creation and maintenance of a public web page for the Ped-In Vivo-TP;
  • Establishment and maintenance with the in Vivo TP Research Team PD(s)/PI(s) of the Standard Operating Procedures (SOPs) for the Ped-In Vivo-TP;
  • Coordination of shipments of compounds supplied by pharmaceutical companies or other entities to Ped-In Vivo-TP Research Teams;
  • Development/implementation of a biospecimen tracking system;
  • Any other important administrative and logistical issues not specified above.

Sub-section C. Data Management, Statistical, and Bioinformatics Support

Describe the proposed approach to the following data management, statistical, and bioinformatics responsibilities:

  • The approach for collection of testing data from the Ped-In Vivo-TP Research Teams;
  • Procedures for ensuring the quality of data that are generated by the Ped-In Vivo-TP Research Teams, including procedures implemented within the Coordinating Center and including on-site audits of the Ped-In Vivo-TP Research Teams (two audits anticipated per site during the 5-year award period);
  • The statistical analysis of data collected from the Research Teams;
  • Procedures for storing testing data and analyses, including plans for data backup and for disaster recovery;
  • Procedures for cross-study analyses to allow patterns of sensitivity and resistance to be recognized across different tested agents;
  • Procedures for bioinformatics analyses to relate patterns of sensitivity and resistance to tested agents to the biological and genomic characteristics of models;
  • Any other important data management and statistical and bioinformatic issues not specified above.

Sub-section D. Scientific Coordination

Describe the proposed approach to the following scientific coordination responsibilities:

  • Scientific Project Management to ensure that the agents tested through the Ped-In Vivo-TP are satisfactorily tracked through all stages from initial review of the agent for testing through the Program to final technical report preparation and publication of results.
  • Development of study research protocols for agents tested through the Ped-In Vivo-TP using a protocol template, focusing on rigorous study designs to reduce experimental errors and increase reproducibility and following accepted guidelines [e.g., NC3Rs ARRIVE (Animal Research; reporting In Vivo Experiments) checklist to the research centers];
  • Development and implementation of metrics for evaluating the performance of Ped-In Vivo-TP;
  • Collaboration with and provision of support to Ped-In Vivo-TP Research Teams in the preparation of technical study reports and manuscripts for agents tested through the Ped-In Vivo-TP;
  • Any other important scientific coordination issues not specified above.

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, should 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 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?

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?

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?

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?

In addition, specific to this FOA:

  • What is the likelihood that the applicant will be able to implement a Coordinating Center that can appropriately manage the administrative, data management and statistical, and scientific coordination requirements of the Ped-In Vivo-TP?
  • To what extent does the application indicate a thorough understanding of the administrative coordination responsibilities of the Coordinating Center of a robust in vivo testing program and propose ways of addressing these responsibilities in a workable and efficient manner?
  •  How adequate is the approach to data management, statistical analysis, and bioinformatics that are workable and that will meet the needs of the Ped-In Vivo-TP for high quality data and reliable analyses?
  • How well do provisions for data storage and data security, backup, and disaster recovery meet the needs of the Ped-In Vivo-TP and protect it from data loss and data breaches?
  • To what extent does the approach proposed for scientific coordination support the ability of the applicant to provide appropriate scientific support in the preparation of research plans, technical study reports, and manuscripts?
  • How well is the proposed plan for scientific project management designed to meet the needs of the Ped-In Vivo-TP in tracking multiple testing projects and ensuring that timelines are being met?

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?

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?

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

For Renewals, the committee will consider the progress made in the last funding period.

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

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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



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

Responsibilities for the Ped-In Vivo-TP Research Team PD(s)/PI(s) and the Ped-In Vivo-TP Coordinating Center PD(s)/PI(s) are aligned, as both are required to function together to successfully implement the research objectives of the Ped-In Vivo-TP.
 

The PD(s)/PI(s) will have the primary responsibility for defining the scientific objectives and approaches and providing oversight of all scientific activities of individual Research Programs. Specific responsibilities are listed below.

Responsibilities of the Ped-In Vivo-TP Coordinating Center awardee will include:

  • Establishment and maintenance of a web-based collaboration system for enhanced communication that includes the capability for sharing of documents and data and that provides tiered access based on role to relevant Ped-In Vivo-TP personnel (e.g., PD(s)/PI(s) and staff of the Ped-In Vivo-TP, PPP SAC members, etc.).
  • Managing the activities of the Ped-In Vivo-TP Steering Committee.
  • Organizing at least one in-person meeting per year with Ped-In Vivo-TP members (in addition to regular conference calls, videoconferencing, and electronic communications) to address issues related to Ped-In Vivo-TP research.
  • Creation and maintenance of a public web page.
  • Establishment and maintenance with the Ped-In Vivo-TP Research Team PD(s)/PI(s) of the Standard Operating Procedures (SOPs) for the Ped-In Vivo-TP.
  • Collection, analysis, and storage of data from each of the Ped-In Vivo-TP Research Teams.
  • Coordination of shipments of compounds supplied by pharmaceutical companies or other entities to Ped-In Vivo-TP Research Teams.
  • Development/implementation of a biospecimen tracking system.
  • Development and implementation of Steering Committee (SC)-approved processes and metrics for evaluating the performance of PPTC Research Programs.
  • Organizing on-site audits of the Ped-In Vivo-TP Research Teams at least two times during the 5-year award period, with a site audit occurring during the first 18 months of funding and with one subsequent site audit. Testing procedures, data management, records maintenance, and animal care facilities will be reviewed.
  • Scientific project management for the Ped-In Vivo-TP testing projects.
  • Participation with the Ped-In Vivo-TP Research Teams in leading the preparation of technical study reports for tested agents and in facilitating preparation of manuscripts.

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

A designated NCI Program staff member serving as Project Scientist/Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may also become substantially involved as needed.

The substantially involved NCI staff members will not attend peer review meetings of renewal or supplemental applications. If such participation is essential, these individuals will seek a waiver according to the NCI procedures for management of conflict of interest

Main responsibilities of substantially involved NCI staff members include the following:

  • Negotiating Material Transfer Agreements (MTAs) with pharmaceutical companies and with Ped-In Vivo-TP Awardees: The Regulatory Affairs Branch (CTEP, NCI) will negotiate MTAs with pharmaceutical companies that will match the terms of MTAs that NCI implements with Ped-In Vivo-TP awardees and that will allow testing of agents by the Ped-In Vivo-TP.
  • Serving as a scientific resource with respect to other ongoing NCI activities that may be relevant to the Ped-In Vivo-TP research efforts to identify promising new research avenues, to facilitate compatibility with other NCI research projects, and to avoid unnecessary duplication of effort.
  • Reviewing research plans prior to submission to pharmaceutical companies.
  • Reviewing Ped-In Vivo-TP manuscripts prior to submission for publication.
  • Advising awardees regarding mechanisms for ensuring appropriate quality control of preclinical testing.
  • Meeting at least once per year with Ped-In Vivo-TP members (in addition to regular conference calls, videoconferencing, and electronic communications) to address issues related to Ped-In Vivo-TP research.
  • Monitoring Ped-In Vivo-TP progress: Actions necessary for monitoring may include, but are not limited to, the following: regular communications with the Ped-In Vivo-TP PD(s)/PI(s) and staff, periodic site visits for discussions with awardee Research Programs, fiscal review, review of study reports submitted by the Ped-In Vivo-TP to NCI, review of the Consortium’s annual progress report, and attendance at Ped-In Vivo-TP meetings.
  • Integrating the efforts of the Ped-In Vivo-TP with other NCI-supported programs for children with cancer (e.g., COG, the PEP-CTN, and the Pediatric Brain Tumor Consortium).

Agents tested will be provided by pharmaceutical collaborators and academic investigators under MTAs based on the provisions of a standard Model MTA.

NCI will have access to all data generated under this cooperative agreement and may review the data as necessary. The awardee will retain custody and primary rights to the data consistent with current HHS, PHS and NIH policies. The awardee will comply with the data access provisions of applicable MTAs, and when these agreements are in place the Industry Sponsor will have complete access to the data for any and all regulatory filings.

Agents tested will be provided by pharmaceutical collaborators and academic investigators under MTAs based on the provisions of a standard Model MTA (http://ctep.cancer.gov/MajorInitiatives/Pediatric_Preclinical_Testing_Program.htm).

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to the Ped-In Vivo-TP awardee institution if it is unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

An NCI Program staff member, acting as the Program Official, will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

  • The Ped-In Vivo-TP Steering Committee (SC) will serve as the body for prioritizing agents for study by the Ped-in Vivo-TP, for defining the overall scope of research plans for agents selected for testing, and for approving the general SOPs under which the Ped-In Vivo-TP operates. The SC will include: the PD(s)/PI(s) of the Ped-In Vivo-TP Coordinating Center and the PD(s)/PI(s) of each of the Ped-In Vivo-TP Research Teams, the NCI Project Scientist, and others as appropriate.
  • The PD(s)/PI(s) of the Ped-In Vivo-TP Coordinating Center and the PD(s)/PI(s) of each of the Ped-In Vivo-TP Research Teams will be expected to serve on the Scientific Advisory Committee (SAC) of the FNIH PPP for pediatric preclinical testing. The SAC will include: the PD(s)/PI(s) of the Ped-in Vivo-TP Coordinating Center and the PD(s)/PI(s) of each of the Research Teams, the NCI Program Director, FNIH representatives, and others as appropriate. The Ped-In Vivo-TP SC may accept recommendations from the PPP SAC for agents to prioritize for testing within the Ped-In Vivo-TP.

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 Ped-In Vivo-TP 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16..

3. Reporting

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

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

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

Malcolm A. Smith, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6087
Email: Malcolm.Smith@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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