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

Administrative Supplements to NCI Grant and Cooperative Agreement Awards to Support Collaborations with the PDX Development and Trial Centers Research Network (PDXNet)(Admin Supp Clinical Trial Not  Allowed)  

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

Administrative supplement requests must be submitted on paper for the following activity codes:


P01 Research Program Projects
P30 Center Core Grants
P50 Specialized Center
U54 Specialized Center- Cooperative Agreements

UM2 Program Project or Center with Complex Structure Cooperative Agreement

Administrative supplement requests may be submitted electronically for the following activity codes:

R01 Research Project Grant
U01 Research Project – Cooperative Agreements

UM1 Multi-Component Research Project Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PA-18-496

Companion Funding Opportunity

None

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

93.393, 93.394, 93.395, 93.396, 93.399   

Funding Opportunity Purpose

This administrative supplement funding opportunity announcement is part of the Cancer Moonshot initiative to accelerate cancer research, and was developed in response to a recommendation from the Blue Ribbon Panel of experts charged with advising the National Cancer Advisory Board on the exceptional scientific opportunities that could be accelerated through this initiative. As part of the Cancer Moonshot initiative, the National Cancer Institute (NCI) created the Patient-Derived Xenograft (PDX) Development and Trial Centers Research Network (PDXNet), a collaborative network of centers of excellence focused on using patient-derived xenografts and other patient-derived models to accelerate the development of NCI investigational new drug (IND) agents (i.e., those that the NCI is developing in collaboration with pharmaceutical partners) in NCI-sponsored early phase clinical trials. This FOA supports supplemental funds to current NCI-funded research projects for new interdisciplinary collaborations between non-PDXNet investigators and PDXNet investigators to perform research within the scientific scope(s) of the parent grant and/or cooperative agreement award(s) that will lead to improved pre-clinical evaluations of novel therapeutic concepts using the large-scale PDX model collections of PDXNet, and that could ultimately be tested in NCI-sponsored clinical trials.

Key Dates
Posted Date

December 15, 2017

Open Date (Earliest Submission Date)

January 30, 2018

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

March 1, 2018, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

May 2018

Expiration Date

March 2, 2018  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all 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 1. Overview Information
    Part 2. Full Text of the Announcement
    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

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

    The National Cancer Institute (NCI) established a Blue Ribbon Panel to assist the National Cancer Advisory Board by providing expert advice on the vision, proposed scientific goals, and

    implementation of the Cancer Moonshot initiative. To meet the goals of the Moonshot panel and to advance the concept of cancer precision medicine, a collaborative network of centers of excellence focused on using patient-derived xenografts (PDXs) and other patient-derived models was formed to accelerate the development of NCI-IND investigational agents (agents NCI is developing in collaboration with pharmaceutical partners) in NCI-sponsored early phase clinical trials (PDXNet). Because PDXNet investigators have valuable models and specialized expertise not usually accessible to most investigators, NCI wanted to make the resources of these centers available to other investigators to test their novel therapeutic concepts.

    The research project proposed in the administrative supplement should align with the overarching goal of PDXNet, which is to develop pre-clinical data to support novel therapeutic concepts that have a feasible path for clinical validation. Furthermore, each supplement request must propose a collaborative project that is within the scope of work already peer-reviewed and approved in the eligible parent awards.

    BACKGROUND

    The evaluation of novel anticancer therapies employing patient-derived xenografts (PDXs) has the potential to increase the precision of clinical treatment assignments by determining the effectiveness of such therapies against more accurate representations of human cancers than previously employed. Patient-derived models, such as PDXs and patient-derived organoids (PDOs), that reflect human tumor biology more closely than established cell lines due to their low passage number, offer the potential of more predictive models than traditional cancer cell lines. When properly derived and maintained, PDXs can provide a representative tumor screening platform for both single agents and drug combinations.

    As more targeted agents become available, and as more refined tumor subtypes are defined, PDXs can help identify and prioritize the optimal combination of agents to test in increasingly narrow tumor subsets in early phase clinical trials. In addition, PDXs may assist in determining the relationships between molecular characteristics or signatures of tumors and therapeutic response with higher resolution and more efficiency (less cost) than can be achieved in human clinical studies. Increasing the precision of cancer therapy requires increasing the resolution of the assignment of therapy to specific diagnoses. For example, PDX studies could potentially identify tumor characteristics that are associated with beneficial response to investigational anticancer drug regimens. PDX programs thus have the potential to provide a path to much more precise assignments of either single agent or combination treatment regimens in cancer therapy.

    As part of the Cancer Moonshot initiative, NCI created PDXNet, a network of centers of excellence that use PDX models on a large scale to address the challenges of cancer precision medicine. PDXNet was formed in 2017, with four PDX Development and Trial Centers (PDTCs)(U54) and one PDXNet Data Commons and Coordinating Center (PDCCC)(U24) being funded in response to two Requests For Applications (RFAs). The primary goal of the PDXNet is to develop PDX trials that test therapeutic strategies in large scale PDX collections that represent the relevant molecular diversity of particular histologies in a context that can feasibly lead to clinical validation of the experimental results. Of note, the PDX research projects in PDXNet are conducted in immune-incompetent mice, and the testing of immuno-oncology strategies is not included in the PDXNet program.

    A secondary goal of the PDXNet is to build a PDX resource that can be accessed by non-network investigators for rigorous PDX evaluation of therapeutic concepts through competitive administrative supplement awards as described below. Therefore, the goal of this solicitation is to provide eligible investigators the opportunity to use PDXNet resources to advance therapeutic concepts within the scopes of projects have already been peer reviewed in applications and funded as grants and cooperative agreements.

    It is anticipated that the awarded funds will be used to support research at the applicant’s institution. It is anticipated that the institutions awarded these funds will provide the necessary information technology (IT) support structure to collaborate with the PDXNet. These will be 1-year supplements to eligible NCI-funded grant and cooperative agreement awards only. Administrative supplement awardees may request a 1-year no-cost extension. However, the project and budget periods of any administrative supplement request must be within the currently approved project period for the existing parent award. Additional administrative supplement funds will separately be made available to one or more of the four PDTCs in the PDXNet to cover the PDTC costs associated with the collaboration.

    Expected elements

    This request for administrative supplements supports NCI’s efforts to enhance the development of PDX models as a tool for precision medicine that will guide cancer drug development and cancer therapy. Requests may include the testing of novel therapeutic combinations in molecularly defined tumor subsets, experiments that examine mechanisms of drug sensitivity and resistance, and development of predictive biomarkers.

    Scope of Support

    The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain augmented/enhanced research objectives as long as they are within the original scope of the project and are related to using PDX models to further pre-clinical development of anti-cancer therapies. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

    The research proposed under the administrative supplement program must be within the original scope of the parent award. Applicants should propose research that, if successful, would lead to incorporation of anticancer agents or biomarkers into future novel clinical trials. The following types of applications are considered to fall within the scope of this program:

    • Testing therapeutic concepts using the large-scale PDXNet model collections, especially concepts that require identification of molecularly defined subsets of histologically defined tumors;
    • Studying mechanisms of intrinsic and acquired drug resistance as well as exceptional therapeutic sensitivity; and
    • Identifying potential biomarkers that could be used to monitor or select patients for therapy.

    The administrative supplement is intended to promote collaborations between PDXNet investigators and non-PDXNet investigators. Therefore, the applicant(s) should both commit to a collaborative effort with PDTC investigators in the proposed studies and expect that the proposed research plan of an approved administrative supplement could be adjusted based on input from the PDTC investigators. It is anticipated that preclinical studies using the PDTC’s models would be performed at the PDTC, and that data and relevant specimens, based on the applicant’s proposed research study, would be sent to the awardee. Information regarding the PDX models that are available at the existing (four) PDTCs can be found at https://www.pdxnetwork.org/supplemental-projects/.

    The scope of proposed projects of the research plan should fit within budget constraints of both the supplement award to the applicant and the separate supplement award to the collaborating PDTC. It is anticipated that the total costs for the administrative supplement for each collaborating PDTC will be approximately equal to the total costs of the supplements awarded under this announcement.

    IC-Specific Considerations

    Applicants are strongly encouraged to discuss their proposed supplement project with the NCI Program Official of the parent grant prior to submission of a supplement application in order to ensure that the content area of the supplement fits within the scientific priorities of the NCI and is within the scope of the parent grant. In addition to contacting the NCI Program Official for the parent grant, applicants are strongly encouraged to include the Scientific/Research Contact person listed in Section VII. Agency Contacts in these communications.

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

    Section II. Award Information
    Funding Instrument

    The funding instrument will be the same as the parent award. 

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

    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

    Non-competing Administrative Supplements

    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

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

    NCI intends to commit $500,000 in FY 2018 to fund four awards.

    Award Budget

    Application budgets are limited to no more than $125,000 total costs per year, regardless of the number of collaborating units. This is exclusive of consortium costs and must reflect the actual needs of the proposed project. The budget should not include the estimated expenses of the collaborating PDTC.

    The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

    Award Project Period

    The project and budget periods must be within the currently approved project period for the existing parent award. The budget period must be for 1 year only.  

    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

    All organizations administering an eligible parent award may apply for a supplement under this announcement.

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

    IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

    Foreign Institutions

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

    Required Registrations

    Applicant Organizations

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

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

    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)

    Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

    For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

    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 is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.  

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

    Applicants must prepare applications using current forms in accordance with the Application Guide.

    Buttons to access the online ASSIST system or to download application forms 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

    All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

    It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

    Page Limitations

    All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed.

    Application Submission

    Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

    Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

    Instructions for Electronic Application Submission through Grants.gov

    Use the “Apply” button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

    Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

    • R&R Cover form: Select “Revision” in the “Type of Application” field.
    • Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities, with the exception of Specific Aims which are not required and will not be evaluated. The Research Strategy should address, in separate sections, the bulleted items below:
    • ·    Summary or abstract of the funded parent award or project.
    • ·    Description of proposed research plan and its relationship to the parent project.
    • ·    Identification of which of the four PDTCs in the PDXNet would be the proposed research collaborator, and how the proposed research project will utilize the resources of the proposed PDTC collaborator.
    • Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
    • Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
    • Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
    • R&R Other Project Information form: If applicable, attach PDF documents in the “Other Attachments” field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents “IACUC Documentation.pdf” and/or “IRB Documentation.pdf”. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement.

    Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

    NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User’s Guide for submitting through this system is available, with the following additional guidance:

    • R&R Cover form: Select “Revision” in the “Type of Application” field.
    • Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities, with the exception of Specific Aims which are not required and will not be evaluated. The Research Strategy should address, in separate sections, the bulleted items below:
    • ·    Summary or abstract of the funded parent award or project.
    • ·    Description of proposed research plan and its relationship to the parent project.
    • ·    Identification of which of the four PDTCs in the PDXNet would be the proposed research collaborator, and how the proposed research project will utilize the resources of the proposed PDTC collaborator.
    • Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
    • Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
    • Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities. Budget information should be entered for the grantee institution in the tabs provided for each selected budget period. Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
    • R&R Other Project Information form: If applicable, attach PDF documents in the “Other Attachments” field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents “IACUC Documentation.pdf” and/or “IRB Documentation.pdf”. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement.

    Instructions for Paper-based Submissions using the PHS 398 Application Forms

    Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:

    • Checklist: Select “Revision” in the “Type of Application” field.
    • Face Page (Form Page 1): On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.
    • Research Plan: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities, with the exception of Specific Aims which are not required and will not be evaluated. The Research Strategy should address, in separate sections, the bulleted items below:
    • ·    Summary or abstract of the funded parent award or project.
    • ·    Description of proposed research plan and its relationship to the parent project.
    • ·    Identification of which of the four PDTCs in the PDXNet would be the proposed research collaborator, and how the proposed research project will utilize the resources of the proposed PDTC collaborator.
    • Project/Performance Sites section (Form Page 2): Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
    • Sr/Key Personnel section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
    • Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities.
    • If applicable, attach documentation in the Appendix section indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement component.

    The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:

    Kim Witherspoon
    National Cancer Institute (NCI) -- Shady Grove campus
    9609 Medical Center Drive, Room 5W604
    For USPS: Bethesda, MD 20892-9741
    For Express Courier: Rockville, MD 20850
    Telephone: 240-276-6141
    Email: Kim.Witherspoon@nih.gov

    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 electronic 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.

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

    For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

    For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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 using the instructions specified above.

    Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.

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

    Important reminders:
    For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

    See more tips for avoiding common errors.

    Post Submission Materials

    Not Applicable

    Section V. Application Review Information
    1. Criteria

    Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

    The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

    Budget and Period of Support

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

    Overall Impact

    NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

    • Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
    • How well does the administrative supplement define the cancer problem to be addressed, including the tumor histology of the PDX models, the anticipated subtypes of the PDX models, and the potential for using the PDX models to answer a significant clinically-relevant question?
    • How well does the administrative supplement request explain why PDXNet resources are required to accomplish the research objectives?
    • Does the administrative supplement application contain relevant preliminary data in support of the proposed research project?
    • Does the approach separate the work to be done at the applicant’s laboratory and the work proposed for the specified PDTC within the PDXNet? (Note: The collaboration can include any one of the PDTCs in the PDXNet.)
    • Does the administrative supplement application describe a feasible path to clinical validation of the proposed project’s research findings?

    In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

    Protections for Human Subjects:

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

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

    Inclusion of Women, Minorities, and Children

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

    Vertebrate Animals

    NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (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

    NIH staff 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.

    2. Review and Selection Process

    Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

    3. Anticipated Announcement and Award Dates

    Not Applicable

    Section VI. Award Administration Information
    1. Award Notices

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

    2. Administrative and National Policy Requirements

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

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

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

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

    Cooperative Agreement Terms and Conditions of Award

    Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

    3. Reporting

    Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

    Scientific/Research Contact(s)

    Jeffrey A. Moscow, M.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-6565
    Email: jeffrey.moscow@nih.gov

    Peer Review Contact(s)

    Not Applicable

    Financial/Grants Management Contact(s)

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