Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)

Funding Opportunity Title

Pre-application for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (X02 Clinical Trial Not Allowed)

Activity Code

X02 Preapplication

Announcement Type

Reissue of RFA-TR-17-001

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-18-909

Companion Funding Opportunity

PAR-18-910, U01 Research Project – Cooperative Agreements

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

93.350  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites pre-applications for projects that test new therapeutic uses for experimental drugs or biologics (Assets) across a broad range of human diseases in adult and pediatric populations. This innovative program allows investigators to propose new therapeutic uses for Assets from pharmaceutical company partners. Strong applications will include scientific evidence that modulation of an Asset’s target will have a positive impact on the disease/condition.     

Key Dates
Posted Date

August 31, 2018

Open Date (Earliest Submission Date)

October 1, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date   

Application Due Date(s)

New Dates October 31, 2018, March 4, 2019, October 31, 2019, March 4, 2020, October 31, 2020, March 4, 2021 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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

Not Applicable

Expiration Date

New Date March 5, 2021 per issuance of NOT-TR-18-032 . (Original Expiration Date: April 30, 2021)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 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

    This FOA invites X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.  The X02 pre-application is the first step in the application process for the companion FOA PAR-18-910. The companion FOA invites applications proposing clinical testing of new therapeutic uses for experimental drugs or biologics (Assets) across a broad range of human diseases in adult and pediatric populations.

    This innovative program matches researchers with a selection of pharmaceutical industry Assets to test ideas for new therapeutic uses with the ultimate goal of identifying promising new treatments for patients. The program was designed to enable efficient 3-way drug repositioning partnerships between academic, government, and pharmaceutical partners. Applicants should read the companion FOA to better understand the program objectives.

    Applicants whose X02 pre-applications are identified as being highly meritorious and relevant to NIH program priorities will be put in contact with the appropriate pharmaceutical company. The applicant institution’s technology transfer group will then work with the pharmaceutical partner to finalize terms and conditions of the confidential disclosure agreement (CDA).

    The pharmaceutical partner and applicant institution will then exchange data and jointly determine whether to begin negotiating terms and conditions for a Collaborative Research Agreement (CRA). If either party declines participation in the partnership, the other party must respect that decision as final.  

    Applicants that obtain a letter of support from the pharmaceutical partner should consider the feedback from the X02 review and any feedback from the participating pharmaceutical partner and prepare a full application for funding (U01) under PAR-18-910. The full application must propose a clinical trial.

    Background

    Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) is a collaborative therapeutics development program. It was designed to enable efficient 3-way drug repositioning partnerships between academic, government, and pharmaceutical partners. Limited confidential information about investigational drugs that would not otherwise be known to the community are publicly posted. See the current Industry-Provided Asset list.

    NCATS seeks the collective intelligence of the crowd to identify new uses for the Assets that may not otherwise be considered. The ideas are received in the form of a brief pre-application to NCATS.

    NCATS serves as a matchmaker for the most meritorious ideas by putting investigators with the best ideas in contact with the appropriate pharmaceutical partner. Both parties exchange data and jointly decide if the collaboration is a good match. 

    The time needed to establish collaborations is shortened to 3 to 4 months (from the typical 9 months to a year) by using template agreements as a starting point for negotiations.

    Research Objectives

    This funding opportunity announcement (FOA) intends to identify meritorious ideas for new uses of existing Assets in previously unexplored diseases, using the limited confidential information that is publicly posted. Applicants should submit an X02 pre-application outlining their idea for a clinical trial.

    NCATS is authorized to support clinical trial activities through the end of Phase II for all diseases or conditions, and through the end of Phase III for a rare disease or condition. For this FOA, a rare disease is defined as a disease or condition that affects fewer than 200,000 people in the U.S. Applicants that wish to apply for support for a Phase III equivalent trial in a rare disease population must verify with NCATS that the planned trial meets the definition of a rare disease at the X02 phase. Learn more: NOT-TR-18-025.

    All the Assets have been in Phase I clinical trials, so human data are already available for dosing, safety, and tolerability. It is expected that ideas for new uses of the Assets may rapidly enter Phase II clinical trials. Generally, the Assets offered already have an abundance of information on pharmacokinetics, genotoxicity, safety pharmacology, and repeat-dose system-route toxicity. 

    Research Areas of Interest

    National Center for Advancing Translational Sciences (NCATS)

    NCATS' approach is generally disease-agnostic and does not favor applications in any disease area over another. It focuses not on specific diseases, but what is common among them and the translational science process. The NCATS mission is focused on process improvements (new technologies/approaches to accelerate the process of getting more treatments/preventions to more patients, more quickly) by developing and deploying solutions that can be used by all translational science researchers. NCATS complements other NIH ICs that also support translational research in disease-specific areas.

    NCATS will consider funding projects that address diseases that have no available treatment or an inadequate treatment, and for which there is strong scientific rationale for the new therapeutic use.

    Application Process

    The submission of an X02 pre-application is the first step in applying for an award under PAR-18-910; applicants should read the companion FOA prior to submitting an X02 pre-application. Each pre-application submitted to the FOA should identify a single Asset (or single mechanism of action in cases where there is more than one Asset available with the same mechanism of action) to be tested for a new use.

    No awards will be made for X02s under PAR-18-910. Investigators of X02 pre-applications, which are identified as being highly meritorious and relevant to NIH program priorities, will be provided contact information for the appropriate pharmaceutical company, based on the Asset or mechanism of action identified in their X02 pre-application. The X02 applicant and pharmaceutical company partner will jointly decide whether a U01 application should be submitted.

    X02 applicants put in contact with the pharmaceutical company partner(s) for the Asset or mechanism of action that was selected for studies in the X02 pre-application are expected to execute an appropriate Confidential Disclosure Agreement (see template CDAs) within 30 days of receiving pharmaceutical company contact information from the NIH. Delays in executing the CDA will reduce the amount of time an applicant will have access to Asset information and may cause delays in assembling the full U01 application.  Under the CDA, the applicant and pharmaceutical company partner will exchange confidential information (e.g., additional information on the Asset and studies to test the proposed new therapeutic use of the Asset), as deemed necessary, to initiate discussions. Subsequently, it is anticipated that a Collaborative Research Agreement (CRA) between the applicant and the pharmaceutical company partner will be the vehicle through which the applicant obtains permission to work with the Asset on the research project plan for the U01 application. As part of the U01 application, the applicant must provide the NIH with documentation of access to the Asset and associated data needed for filing an investigator-sponsored Investigational New Drug (IND) Application and for conducting the proposed clinical trial.

    Partnership Information

    A key aspect of this FOA is the formation of collaborative partnerships between the biomedical research community and industry partners. NCATS has executed a Memorandum of Understanding (MOU) with each of the pharmaceutical company partners to provide a framework under which specific proprietary Assets will be provided by these partners to the program awardees.

    Template agreements have been developed for this program and include Confidential Disclosure Agreements (CDAs) and Collaborative Research Agreements (CRAs) between the pharmaceutical company partner and the applicant. These template agreements have been developed to streamline interactions among the parties for the Program, and it is anticipated that applicants will use the agreements.

    Assets Available for the Program

    The list of Assets and non-confidential information can be found here. The Assets are posted in two separate tables: 1) Table of Assets for Adult Indications and 2) Table of Assets for Pediatric Indications. Some of the compounds in the Table of Assets will be more amenable to exploration/use in pediatric populations based on the Biopharmaceutical Classification System (BCS), adult safety data, expected palatability issues, bioavailability and other criteria. Assets pharmaceutical companies will consider for use in pediatric populations are listed in the Table of Assets for Pediatric Indications.

    Applicants need to refer to the "Additional Characteristics" row of the more detailed Asset information chart for the Asset of interest to determine the type(s) of pediatric diseases the pharmaceutical company will consider. Asset lists for this FOA will be announced prior to any award cycle. Assets will not be added or removed during any award cycle, except for unanticipated safety reasons. Asset lists may be updated twice annually via a Notice.

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

    Section II. Award Information
    Funding Instrument

    Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    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

    No awards will be made under this announcement. Awards will be made through the companion FOA, PAR-18-910.

    Award Budget

    Not Applicable.

    Award Project Period

    Not Applicable.  

    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)

    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
    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) (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.

    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.

    For these X02 pre-applications, the PD/PI listed on the X02 pre-application must be the same PD/PI listed on a subsequent U01 application. For X02 pre-applications proposing multiple PD(s)/PI(s), the contact PD/PI listed on the X02 pre-application must be the same PD/PI listed on a subsequent U01 application. The contact PD/PI is strongly encouraged to continue the multiple PD(s)/PI(s) leadership identified in the X02 pre-application if notified of the opportunity to submit a U01 application.

    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

    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

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

    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:

    Email:  NewTherapeuticUses@mail.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.

    Type of Submission: Select "Pre-application".

    Total Federal Funds Requested: Enter "0".

    Total Federal and Non-Federal Funds: Enter "0".

    Estimated Program Income: Enter "0".

    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.

    Are Human Subjects Involved: Answer "No"

    Are Vertebrate Animals Used: Answer "No"

    Other Attachments: Attach Asset information for the Asset selected for use in the project, available at https://ncats.nih.gov/ntu/assets/current, and title it "Asset Information".  

    SF424(R&R) Senior/Key Person Profile

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

    R&R or Modular Budget

    Budget forms are not included as part of the pre-application package.

    R&R Subaward Budget

    Budget forms are not included as part of the pre-application package

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims: 

    • Define the aims of the Phase I dosing, safety and tolerability clinical trial, if such a trial is proposed.
    • Define the aims of the Phase II preliminary effectiveness clinical trial. The aims should address target modulation and efficacy.
    • If applying for a rare disease study, include the aims for an adequate and well-controlled clinical trial for a rare disease (NOT-TR-18-025).

    The clinical data should provide sufficient evidence that the drug candidate is safe and well-tolerated for administration in the proposed dose range; modulates the target/mechanism and a biomarker of PD effect; and has the potential to yield the desired clinical outcome in the disease population.

    Research Strategy: 

    Within the Research Strategy, provide the following information:

    • Background and Significance: Provide the scientific rationale for selection of the Asset or mechanism of action and its proposed new therapeutic use.
    • a. Identify the proposed Asset (or identify the mechanism of action if multiple Assets are listed with the same mechanism of action) from among those made available for this Program that you are interested in using, its known pharmacologic mechanism of action or target, and the new therapeutic use which will be investigated.
    • b. Clearly describe the patient population to be studied. If the disease/condition exists in both children and adults and only a pediatric trial is proposed, include a strong scientific justification for testing the Asset in a pediatric patient population instead of testing in an adult patient population (e.g., the target in the pediatric population may differ from that in the adult or treatment of children may reduce progression or severity of the disease).
    • c. Describe the potential impact of the novel therapeutic use of the Asset for the disease or disorder.
    • d. Describe how the mechanism under investigation differs from previous studies/trials for this indication. Include any information on ongoing or completed clinical trials investigating the same target/mechanism of action in the proposed patient population. Discuss the value added of the proposed studies.
    • e. Address the global burden of disease, which patients may benefit, how they may benefit, how use of the Asset might be superior to current therapy options and potential for impact on public health.
    • Preliminary Studies
    • a. The Preliminary Studies section may contain data and information that validate feasibility for conducting the proposed studies.
    • 1). Evidence that the target or specific pathway is involved in the disease pathology. Examples may include, but are not limited to:
    • (a) In vitro or in vivo evidence that a specific target/pathway is involved in the disease pathology.
    • (b) Evidence that modulation of the Asset’s target will have a positive impact on the disease or disorder proposed.
    • Approach: Provide a preliminary plan to assess the validity of the biological hypothesis for use of the Asset in the new disease area. Describe the trial to the best of your ability, with the limited information that is available about the Asset.
    • Administration and Management
    • a. Describe institutional and/or team experience with FDA regulatory processes.
    • b. Describe the team's experience in the methods and approaches for design and implementation of human clinical trials and readiness to test the hypothesis.
    • c. Describe the team's requisite competencies and experience with clinical trials recruitment and execution and ability to recruit and enroll patients in the target disease population.

    Letters of Support: Applicants must include a letter from an appropriate institutional official, generally a dean or provost, documenting institutional commitment to the project, including provision of resources, space, and available faculty.

    Include in the letter confirmation the Institution’s willingness to engage in the necessary negotiations with the pharmaceutical company regarding the terms and conditions of the template CDA and CRA for the selected Asset or mechanism of action.

    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, with the following modification:

    A Resource Sharing Plan (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) is not applicable for this X02 FOA.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modification:

    Appendices are not allowed for this FOA and will not be accepted. Do not use the Other Attachments section to circumvent this limitation.

    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or 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 with the following additional instructions:

    The PHS Human Subjects and Clinical Trials Information record is not applicable for this X02 FOA.

    Delayed Onset Study

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

    The Delayed Onset Study record is not applicable for this X02 FOA.

    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 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:

    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, NIH. Applications that are incomplete or non-compliant 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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    For this particular announcement, note the following:

    This pre-application FOA invites ideas for new therapeutic uses of existing molecules (Assets) from pharmaceutical company partners.

    Pre-applications that are complete will receive written feedback.  Applicants are encouraged to incorporate the feedback on the X02 application in discussions with the pharmaceutical partner.

    Reviewers will assess the applicant’s ability to address the following:

    1) Does the investigative team have the requisite competencies and experience with drug development including regulatory processes, clinical trial planning, recruitment and execution?  Does the team provide evidence to support their suitability to recruit and enroll patients from the target disease population?

    2) Are there ongoing or completed clinical trials modulating the same target/mechanism of action for this patient population?  How would this clinical trial be novel?

    3) Although the Asset itself was not accessible to the PD/PI, is sufficient evidence presented to support the scientific rationale for the proposed new use of the Asset (its pharmacologic mechanism of action or target) and relevance of the biology to therapeutic intervention in the proposed disease? If the applicant is proposing studies in a pediatric population for a disease/condition that exists in both children and adults, is there sufficient scientific justification for testing the Asset in a pediatric patient.

    Resubmissions

    Not Applicable.

    Renewals

    Not Applicable.

    Revisions

    Not Applicable.

    Additional Review Considerations

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

    Applications from Foreign Organizations

    Not Applicable.

    2. Review and Selection Process

    Applications will be evaluated based on the review criteria above by (an) appropriate Scientific Review Group(s) convened by NCATS.

    Applications will be administratively assigned to NCATS for processing.

    Applications will receive written feedback. 

    Investigators whose X02 pre-applications are identified as being highly meritorious and relevant to program priorities will be notified of the opportunity to submit a U01 application under PAR-18-910.

    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

      Not Applicable. 

    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

    Not Applicable

    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 on-time submission, 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 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)

    Bobbie Ann Mount, Ph.D.
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-435-0824
    Email: bobbieann.mount@nih.gov

    Peer Review Contact(s)

    Carol Lambert, Ph.D. 
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-435-0814
    Email: Lambert@mail.nih.gov

    Financial/Grants Management Contact(s)

    Gloria Velez
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-435-0875
    Email: gloria.velez@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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