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
Urgent Phase I/II Clinical Trials to Repurpose Existing Therapeutic Agents to Treat COVID-19 Sequelae (U01 Clinical Trial Required)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-TR-20-003
Companion Funding Opportunity

None

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

93.350

Funding Opportunity Purpose

The purpose of this urgent funding opportunity announcement is to invite applications to repurpose existing therapeutic agents to treat Coronavirus Disease 2019 (COVID-19) sequelae and associated complications that result from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections. The therapeutic agent must have already completed at least a Phase I clinical trial for a different indication, and not require additional regulatory studies for the new indication prior to starting a clinical trial.

Key Dates

Posted Date
August 05, 2020
Open Date (Earliest Submission Date)
August 06, 2020
Letter of Intent Due Date(s)

Not Applicable.

Application Due Date(s)

Applications will be accepted on a rolling basis, beginning on August 6, 2020.

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

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

AIDS Application Due Date(s)

Not Applicable.

 

 

Scientific Merit Review

Applications will be handled on an expedited review and award basis to meet the goals of this program.

Advisory Council Review

Not Applicable.

Earliest Start Date

Applications will be handled on an expedited review and award basis to meet the goals of this program.

Expiration Date
January 24, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this urgent Funding Opportunity Announcement (FOA) is to provide an expedited funding mechanism for applications to repurpose existing therapeutic agents to treat Coronavirus Disease 2019 (COVID-19) sequelae and associated complications that result from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections. NCATS is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19).

Background

There is an urgent public health need to find therapies to ameliorate COVID-19 disease sequelae resulting from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections. Many existing therapeutic agents already have been tested in humans, and detailed information is available about their pharmacology, formulation, safety and potential toxicity. By building upon previous research and development efforts, new uses for existing therapeutic agents can be advanced to testing in clinical trials more quickly than starting from a new molecular entity. If a new therapy receives regulatory approval, it can be efficiently integrated into clinical practice.

Research Objective

This urgent Funding Opportunity Announcement (FOA) intends to support rapidly implemented Phase I (when needed) and/or Phase II clinical testing of existing therapeutic agents to treat COVID-19 disease sequelae and associated complications that result from SARS-CoV-2 infections. These rapidly implemented early stage trials must have regulatory clearance (e.g., IND, Investigational New Drug Application) to provide study drug to human subjects by the time an award is made.

Scientific Scope

This initiative will support early stage clinical trials (through Phase II) on existing therapeutic agents that are already marketed or have been tested in humans in another Phase I clinical trial prior to application submission. The proposed clinical trials must use a readily available formulation for which preclinical safety studies have already been completed. Definitions of clinical trials for the purpose of this funding opportunity are as follows:

  • Phase I clinical studies: Studies conducted in the target patient population (e.g. 20-80) and healthy volunteers, where the purpose is to evaluate safety, determine a safe dose range, and identify side effects prior to conducting a Phase II clinical trial.
  • Phase II clinical studies: The therapeutic agent is given to a larger group of people (100–300) to determine its efficacy and to further study its safety.

Prospective applicants should not propose testing a therapeutic agent that significantly duplicates what already is being or has been clinically tested for COVID-19 sequelae and associated complications that result from SARS-CoV-2 infections prior to an NIH award being made. Projects on novel targets will be a higher priority for support than projects that propose using a study drug that is already publicly posted anywhere in the world as already being clinically tested in COVID-19 patients (or retrievable in NIH databases but not yet publicly registered).

Research areas of interest

The objective of this urgent funding opportunity is to provide funding for projects that ameliorate disease sequelae including respiratory, cardiovascular, digestive, nervous system, pediatric conditions, and other sequalae yet to be determined.

Projects should pivot existing infrastructure and capacity to address the acute needs resulting from this pandemic.

The following will be considered non-responsive to this FOA and will not be reviewed.

Applications that:

  • request NIH support for work in animal models to demonstrate efficacy, to conduct non-clinical safety or toxicity studies, or to support assessment of drug-drug indications as a combination product;
  • propose a new formulation or route of administration that has not been tested in humans, and there is no evidence that preclinical safety studies were completed prior to application;
  • propose testing an anti-infective or immunomodulator for the purpose of fighting SARS-CoV-2 viral infection, or treatments to address immunopotentiation that may result from a SARS-CoV-2 vaccine;
  • propose testing the effectiveness of a dietary supplement that cannot be reliably dosed or that is present in food products that are likely to be ingested during the clinical studies;
  • have not already initiated regulatory clearance (e.g., submitted paperwork for an IND) for clinical studies;
  • do not provide evidence that the therapeutic agent has already been tested in at least one Phase I clinical trial for a different indication prior to application, so there is some human data available to understand safety and toxicity;
  • propose Phase III clinical trial activities.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?
Required: Only accepting applications that propose clinical trial(s)

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.

Award Budget

The budget is limited to $3,000,000 direct costs/year.

Award Project Period

The project period may be up three years. However, given the nature of the pandemic, many studies should be completed expeditiously - within one or two years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

  • U.S. Territory or Possession

Other

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

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

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

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

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

For this specific FOA, the Research Strategy section is limited to 12 pages.

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments:

 Other attachments indicated below must be provided or the application will be considered incomplete and will not be reviewed:

Required Therapeutic Agent and Regulatory Status Summary

Upload a 1-2 page table named [Therapeutic Agent and Regulatory Status] that contains the following information:

  • Name of the therapeutic agent, owner, and any present/past nomenclature for the therapeutic agent.
  • Mechanism of action with links to any pertinent references.
  • Publicly posted links to clinical trials that used the therapeutic agent.
  • Other information, e.g., CNS penetrance (if applicable).
  • Links to key publications.

In addition to the sample therapeutic agent tables posted here (https://ncats.nih.gov/ntu/assets/current), applicants should also provide a synopsis of the regulatory status for the new use: 1) Indicate whether an FDA-approved therapeutic agent is available for purchase; 2) whether or not a new regulatory clearance (e.g., IND) is needed (or if the project already fits into an existing open-IND, for example). (NOTE: Applications may be submitted prior to receiving regulatory clearance; however, all award funds will be restricted until receipt of regulatory clearance (i.e., either a "study may proceed letter" or a letter from an Authorized Organization Representative (AOR) stating that 30 days have passed since the IND was submitted, so enrollment may proceed.)

Required Therapeutic Agent Resource Access Plan

The applicant must provide an attachment labelled [Therapeutic Agent Resource Access Plan]

  • The applicant must include a plan to access the clinical material needed during the proposed project period, if an NIH award is made.
  • Indicate if the therapeutic agent to be clinically tested is already marketed or available for purchase.
  • Clearly identify any known challenges with obtaining sufficient drug supply that could delay enrollment of subjects in a clinical trial (e.g., only manufactured in one geographic location by a single manufacturer; proprietary component that a commercial partner will not disclose; identify any unique challenges for packaging such as a sticky capsule; identify any known possible shipping delays or increased shipping expense during a pandemic).
  • The Resource Access Plan should address any additional complexities associated with materials and data obtained from foreign sources, if applicable.
  • If the therapeutic agent is not marketed and will be manufactured as an Experimental Drug for this study, provide evidence that a Phase I trial for a different indication has been conducted on the therapeutic agent (publication, clinicaltrials.gov registration number, etc.), or include documentation from the therapeutic agent provider that clearly states that a Phase I trial for a different indication has been completed and indicates by whom the trial was conducted.
  • For projects that propose using a therapeutic agent owned by a small company, the applicant must explain how risks will be mitigated for federal investment. Include a plan to access the clinical material needed during the proposed project period, if an NIH award is made.

Required Milestone plan

The applicant must provide a 1-2 page document labelled [Milestone Plan]

A plan that includes quarterly milestones for each clinical stage must be attached that contains the following information for each goal:

  • Measurement
  • Go/no-go criteria
  • Quantitative criteria for success for each milestone (when applicable)
  • Estimated quarterly completion dates in each year of the research plan.
SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

The Budget should include:

  • resources for conduct and completion of the clinical trial, including funding for orderly close-out of clinical sites, and preparation of a final study report.
  • site assessment and protocol training, prior to initiation of a clinical trial.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims:

Applicants must provide a single specific aims attachment. 

  • Identify the therapeutic agent that is being repurposed to treat COVID-19 disease sequelae.
  • Summarize the type of trial and control or comparator.

The Research Strategy should include the following considerations that are specific to this FOA in each section of the research strategy in the PHS 398 Research Plan form.

Significance:

  • Significance of the proposed work to the patient population -- which patients will benefit; how patients will benefit; and the potential public health impact if the proposed research successfully translates to the clinic.

Innovation:

  • Describe the novelty of the target class for the COVID-19 sequela, or how the mechanism of action of the therapeutic agent has been understudied for the indication. If a similar in class therapeutic agent is publicly posted as being clinically tested already, discuss the added value of the proposed studies.

 Approach:

Without duplicating details in the PHS Human Subjects and Clinical Trials Information Form, describe the following:

Clinical trial feasibility

Describe the patient populations (numbers and demographics) at the site(s) and summarize any competing clinical trials at the same site(s) for the same patient population.

  • Identify availability of individuals with the disease or condition being tested at the study site.
  • Identify whether the distribution by age, sex/gender, race, and ethnicity is representative for the disease/condition being tested.
  • Identify the feasibility of inclusion/exclusion criteria.
  • Determine if drug-drug interactions exclude too many subjects with the condition for the experimental therapy to be feasible to use in the proposed study population, based on existing literature and data.
  • Estimate how many study sites will be needed to complete the study within a reasonable timeframe.

Therapeutic agent

  • Summarize any human data that informs the dose range and amount of therapeutic agent needed, addressing any intrinsic factors in the patient population that may differ from the current use (for safety/toxicity), and availability of the amount of therapeutic agent needed.
  • Address any known challenges with manufacturing, packaging, or shipping of the therapeutic agent in the form it will be administered to human subjects at the study sites.
  • Address whether matched placebo will be used and if not, what objective measures will be used to assess outcome.

Regulatory status and IRB approval

Phase I clinical trial (when applicable):

If a Phase I clinical trial is needed, provide an overall plan to assess the validity of the biological hypothesis. Include the following:

  • Specify dose range of the therapeutic agent.
  • Describe the use of PK and PD biomarkers, when available, to assess dose and exposure of the therapeutic agent at the target site of action; binding at the target; and expression of functional pharmacological activity of the therapeutic agent at the target site of action.

Phase II clinical trial: Provide an overall plan for the preliminary efficacy signal Phase II clinical trial. Include the following:

  • Describe the clinical trial design, based on available safety data for the therapeutic agent.
  • Define the patient selection strategy.
  • Include a discussion about the use of molecular markers of disease, pharmacogenomics, or other biomarkers, when applicable.
  • Specify dose range, PD parameters used to perform dose ranging, route of administration, and amount of therapeutic agent needed.
  • Justify the number of patients chosen for the Phase II trial (based on the proposed outcome measures and the appropriateness of the statistical methods).
  • Justify the sample size and duration of the Phase II clinical trial for the specific disease population.
  • Provide assurance that the proposed study can be completed within its budget and within the time limits stated in this FOA.

Letter of Support from Therapeutic Agent Provider of an Experimental Asset (when applicable)

For studies where an existing therapeutic agent is provided by a pharmaceutical partner, a letter of support must be provided by the pharmaceutical partner, indicating that a Collaborative Research Agreement or equivalent (see examples) will be executed, and the PD/PI has the right to cross-reference specific sections of the pharmaceutical company partner's IND/Drug Master File, etc.

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

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:

Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Please submit any letters from FDA that either say "study may proceed" or "clinical hold" no later than 14 days prior to review. Alternatively, provide a letter from the Authorized Organization Representative (AOR) stating that 30 days have passed since an IND clearance process was initiated without a reply from FDA.

Section V. Application Review Information

1. Criteria

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

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

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

Scored Review Criteria

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

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this FOA: Does the application clearly state the significance of the proposed work to the patient population, including which patients will benefit, and how?

 

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

Regarding the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this FOA: Are the personnel resources available for clinical trial document preparation adequate?

 

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

Specific to this FOA: To what extent does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

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

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this FOA: For already marketed drugs, how will the investigators address potential supply chain issues anticipated during the COVID-19 epidemic?

If the therapeutic agent is not commercially available, have the investigators included plans to address potential known challenges with manufacturing, packaging, shipping, or dispensing study drug in the dosage form that will be administered to subjects at study sites? Are these plans feasible?

Have the investigators included plans to address any known challenges with achieving enrollment goals at the proposed sites (e.g., competition with other ongoing clinical studies in the same patient population)? Are these plans realistic?

Do the applicants present human data that informs the dose range and amount of therapeutic agent needed, addressing any intrinsic factors in the patient population that may differ from the current use (for safety/toxicity), and availability of the amount of therapeutic agent needed? Are the plans to deal with variable dose range and amount of therapeutic agent needed reasonable?

To what extent do the applicants address the possibility that drug-drug interactions exclude too many subjects with the condition for the experimental therapy to be feasible to use in the proposed study population, based on existing literature and data? How will they address this potential problem?

Does the study design provide quantifiable endpoints or outcomes for making go/no-go decisions that are clinically significant for validating the new therapeutic agent use? Which objective measures will be used to assess outcome and are those measures adequate?

Phase I clinical trial (when applicable):

Does the overall plan assess the validity of the biological hypothesis? How effectively does the trial assess dose and exposure of the therapeutic agent at the target site of action; binding at the target; and expression of functional pharmacological activity of the therapeutic agent at the target site of action?

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

 

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

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall merit score.

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

 

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

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

 

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

 

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

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

Not Applicable.

 

Not Applicable.

 

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not consider them in providing an overall merit score.

 

Not Applicable.

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate internal Review Group(s) convened by NCATS, using the stated review criteria.

All else being equal, the following will be a higher programmatic priority for support.

  • Projects on novel targets will be a higher priority for support than projects that propose using a study drug that is already publicly posted anywhere in the world as in COVID-19 patients (or retrievable in NIH databases but not yet publicly registered).
  • Projects that already have regulatory clearance and IRB approval will be a higher priority than projects that have started but not completed these steps.
  • Projects that can be completed expeditiously (e.g., within one or two years) will be a higher priority for support than longer term projects.

As part of the merit review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and evaluated.

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

Applications will be assigned to NCATS and will compete for available funds with all other recommended applications submitted in response to this FOA.

The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by merit review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Likelihood that the trial can be completed within the specified timeframe.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

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

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

  • Determining the experimental research approaches, designing protocols, setting project milestones and go/no go decision points, and conducting the project within the guidelines of the FOA; but they must consider and incorporate constructive feedback on improvements to scientific rigor received from the Clinical Trial Oversight Committee (CTOC).
  • Submitting an investigator-sponsored IND, assuming responsibility for the development, assembly, and submission of all required regulatory documents, and providing all required information to NIH staff. This includes but is not limited to all communications with the Food and Drug Administration (FDA)/or other regulatory authority and the IRB.
  • Complying with all federal regulations and NIH policies, including those related to clinical research and clinical trials. Adhering to NIH requirements for clinical trial monitoring, including oversight by an independent NIH Data and Safety Monitoring Board (DSMB) if required by NIH.
  • Ensure timely submission of Phase I and Phase II clinical trial data to ClinicalTrials.gov.
  • Ensuring the timely submission of the clinical trial protocol, consent form, and periodic reports for the project to the NIH, as required.
  • Ensuring timely submission of all information and documents required by NIH, for oversight of the project and data and safety monitoring.
  • Submitting required documents, including adverse events or unanticipated problems, to the FDA or Office of Human Research Protections (OHRP) in a timely manner as required by regulation, and submitting these reports to NIH staff at the time of submission to the appropriate agency.
  • Inviting external scientist(s) to serve as advisors on the CTOC as needed, in consultation with the NIH Program Official, NIH Project Scientist, and pharmaceutical company partner (if applicable).
  • The PD(s)/PI(s) will serve as chair the CTOC, organizing and circulating a written agenda in advance of conference calls and meetings, and preparing and circulating minutes that delineate decisions and action items resulting from the calls or meetings.
  • Convene quarterly teleconferences to monitor progress on the research project plan and to address issues or activities that impact the project or progress on the milestones.
  • Adhering to relevant policies and accepting the participation and assistance of NIH staff in accordance with the guidelines described in the NIH staff responsibilities in the Terms and Conditions of Award.
  • Providing a progress report, due 60 days prior to completion of the budget period to the NIH, as specified in the Notice of Award.
  • Retaining custody of and having primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
  • Addressing all study design, operational and logistical issues, and safety, regulatory, ethical, and conflict of interest concerns raised by NCATS staff.
  • Complying with the clinical terms of award as articulated in the Notice of Award (NoA), such that no funds may be drawn down from the payment management system and no obligations may be made against federal funds for any research involving human subjects until a revised NoA is received.
  • Ensure timely publication of abstracts and scientific articles to make results of projects and inventions available, including negative data regarding new therapeutic agent uses.

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

The Project Scientists will:

  • Have substantial scientific/programmatic involvement during conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants.
  • Coordinate with the awardees in monitoring issues relating to: design of the activities, recruitment, adherence to protocols, adjustment of study protocols, and management and technical performance.
  • Participate in CTOC activities, including conference calls.
  • Participate in the review of clinical research protocols and clinical monitoring plans, and depending on their level of complexity and risk, recommend further review by the DSMB or another monitoring body.
  • Participate in project update meetings with the PD/PI.

The Program Official will:

  • Be responsible for the normal scientific and programmatic stewardship of the award.
  • Participate in project update meetings and conference calls.
  • Monitor recruitment status of the trial on an ongoing basis.
  • Monitor performance through consideration of quarterly meetings of the CTOC, annual reports, and compliance with NIH procedures.
  • Approve modifications to the research plan and/or study protocol(s), in consultation with the CTOC, based on emerging data and/or other issues that impact progress of the project.
  • Reserve the right to obtain periodic external review and select reviewers for an assessment of progress and achievement of milestones.
  • Reserve the right to terminate or curtail a project for any of the following reasons: (1) inadequate progress in meeting the pre-negotiated milestones and timelines; (2) risk(s) to subject’s safety; (3) slow accrual; (4) data from a futility analysis; or (5) failure to comply with the Terms and Conditions of Award.

Areas of Joint Responsibility include:

Clinical Trial Oversight Committee (CTOC):

Each awardee's project will have a CTOC. The CTOC will include: the PD(s)/PI(s), key personnel, the NIH Project Scientist (voting), the NIH Program Official (ex officio), and (as needed) external scientist(s).

The CTOC will:

  • Recommend changes to the experimental design and/or clinical trial plan, to address obstacles encountered and solutions and compliance with relevant policies and regulations.
  • Participate in monitoring of intellectual property arising from the project.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a member chosen by the individual awardee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16. Follow special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

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

Matt Zeback
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-8309
Email: matthew.zeback@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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