Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Expanding Extramural Research Opportunities at the NIH Clinical Center (U01 Clinical Trial Optional)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-18-879

Companion Funding Opportunity

None

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

93.855 

Funding Opportunity Purpose

The purpose of this FOA is to support extramural investigator-initiated clinical research in partnership with the NIH Clinical Center in Bethesda, MD. This new FOA will leverage the resources (inpatient and outpatient) and assets of the NIH Clinical Center (e.g., scientific and clinical expertise, nursing, beds, critical care services, ambulatory care services, laboratories, imaging, biostatistics, protocol development, regulatory guidance, clinical trials management and safety oversight) in accelerating the discovery and translation from laboratory to clinic of therapies for infectious (including primary immunodeficiency diseases), immunologic, and allergic diseases. Specifically, it will support hypothesis-driven mechanistic studies alone or within clinical projects employing Phase 0, 1, and/or 2a clinical trial designs.    

Key Dates

 

Posted Date

July 26, 2018

Open Date (Earliest Submission Date)

November 2, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

December 3, 2018, December 3, 2019, December 3, 2020 , 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)

December 3, 2018, December 3, 2019, December 3, 2020, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related 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.

Scientific Merit Review

April 2019

Advisory Council Review

May 2019, May 2020, May 2021

Earliest Start Date

July 2019

Expiration Date

December 4, 2020

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
    Background

    The NIH Clinical Center is the largest biomedical research hospital in the world, and it is a unique local, regional, and national research resource. Although this Clinical Center represents a key resource for NIH intramural scientists to conduct clinical research and clinical trials, extramural scientists funded by NIH grants and contracts also may access this distinctive facility. To ensure the Clinical Center maximizes its potential to support the best possible extramural science, the NIAID wants to leverage these valuable inpatient and outpatient clinical research resources with the needs of the extramural community.

    The NIAID mission is to conduct and fund research to understand, treat, and prevent infectious, immunologic and allergic diseases. Scientific priorities are described in the NIAID Strategic Plan, 2017pdf. Extramural scientists proposing research within NIAID's priorities have an opportunity to utilize the unique resources of the Clinical Center (for a description of resources, see https://clinicalcenter.nih.gov/translational-research-resources/resources.html). Support for clinical research and clinical trials conducted by NIAID and NIAID-funded scientists is also available through the NIAID Division of Clinical Research (DCR). DCR provides multi-disciplinary trans-NIAID services to facilitate clinical research, such as assisting in protocol development, study design, statistics and regulatory compliance (see https://www.niaid.nih.gov/about/dcr).

    In particular:

    Research Objectives and Scope

    The goal of this FOA is to support extramural investigator-initiated clinical research in partnership with the NIH Clinical Center in Bethesda, MD. This new FOA will leverage the resources (inpatient and outpatient) and assets of the NIH Clinical Center (e.g., scientific and clinical expertise, nursing, beds, critical care services, ambulatory care services, laboratories, imaging, biostatistics, protocol development, regulatory guidance, clinical trials management and safety oversight) in accelerating the discovery and translation from laboratory to clinic of therapies for infectious (including primary immunodeficiency diseases), immunologic, and allergic diseases. Specifically, it will support hypothesis-driven mechanistic studies alone or within clinical projects employing Phase 0, 1, and/or 2a clinical trial designs. In the context of the FOA, a clinical project is a clinical trial together with integrated mechanistic or genetic studies.

    Types of clinical trials and clinical research that may be proposed include but are not limited to the following:

    • Phase 0 clinical trials in healthy subjects (e.g., assess safety and explore pharmacokinetic (PK) characteristics of promising interventional agents (e.g., drugs, cells, and molecules) or new formulations of FDA approved drugs (e.g., calcineurin inhibitor immunosuppression)
    • Observational clinical research with associated mechanistic studies and/or genetic studies
    • Chronic allograft injury and destruction after organ transplantation
    • Treatment of post-transplant cancers
    • Treatment of post-transplant lymphoproliferative disease (PTLD)
    • Identification of genetic determinants of outcome or response to therapy in organ transplant recipients
    • Infectious disease challenge studies in healthy volunteers
    • Phase 1 (initial safety trial) and 2a pilot clinical trials to evaluate efficacy (and safety) in patients with the immune-mediated disease or condition to be treated, diagnosed, or prevented
    • Repurposing drugs approved for other indications for diseases within the NIAID mission based on the known mechanism of the drug
    • Cross-sectional and epidemiologic studies in specific disease cohorts looking at intermediate and long-term follow-up
    • Evaluation of immune response to licensed vaccines in special populations
    • Infectious diseases studies in special populations, including primary immunodeficiency diseases, concurrent diseases states, cystic fibrosis
    • New therapeutic approaches applying cutting edge advances in fundamental immunity and biology. Examples include: microbiome, gene therapy, regulating gene transcription, RNA metabolism, cellular therapy, cytokines, chemokines, and proteins mediating signal transduction
    • Develop diagnostic, predictive, and critical biomarkers that will facilitate routine surveillance, early diagnosis and ongoing monitoring of processes that contribute to morbidity and mortality for immune mediated diseases (e.g., organ transplantation, autoimmune disease, primary immunodeficiency diseases, allergy and asthma)

    Specific areas of interest include:

    • Clinical research focused on the high priority areas in HIV/AIDS within the NIAID mission (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html )
    • Allergy
    • Food allergy
    • eosinophilic and/or mast cell disorders
    • anaphylaxis
    • drug allergy including interest in immunologic basis of severe adverse drug reactions, diagnosis of drug allergy, role of IgE in drug allergy
    • Atopic dermatitis (eczema) and other allergies (e.g., rhinitis, rhinosinusitis)
    • Primary immunodeficiency diseases
    • Rare diseases in the areas of infectious, primary immunodeficiency, autoimmune, solid organ transplantation and allergic diseases
    • Acute and chronic inflammatory disease (e.g., inflammatory bowel disease)
    • Human immunology in context of biodefense
    • Transplantation immunology (organs, tissues, cells, and molecules)
    • New interventional immunotherapeutics
    • Host defense
    • Infectious diseases
    • Novel therapeutic vaccination approaches

    NIAID reserves the right to specify: 1) whether an Investigational New Drug (IND)/ Investigational Device Exemption (IDE) application should be submitted to an appropriate regulatory agency and determine the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE. In most cases, it is expected NIAID will not hold the IND/IDE and the primary extramural awardee has engaged with appropriate regulatory agencies with the IND/IDE in hand (as necessary or required) at the time of grant application. Potential applicants are encouraged to discuss their research proposal and potential need for formal regulatory consultation with the NIAID Program Officer in consultation with CC personnel. It is expected that the IND/IDE would be finalized within 6 months of award.

    Milestones

    Milestones are a key component of the clinical trials awarded under this announcement and are only required if proposing a clinical trial. A milestone is defined as a scheduled event in the project timeline, signifying completion of a major project stage or activity. In the case of clinical trials, milestones commensurate with opening enrollment, quantitative yearly milestones, and completing clinical trial(s) within the period of award will be incorporated into the terms of award. Completion of research reports, preparation of peer-reviewed manuscripts, and data sharing are required milestones when individual study end points are met.

    Planning Activities

    It is expected that all necessary activities associated with the proposed research, especially in the case of clinical trials, will not be complete at the time of submission. Up to one year may be used to support planning, design, and preparation of documentation necessary for implementation of the proposed research with the clinical center.

    Planning activities that may be proposed include but are not limited to the following:

    • Final protocol development
    • IRB approval
    • Review from regulatory agency (if applicable)
    • Development of data safety monitoring plan
    • Recruitment plan

    It is anticipated that the clinical research activities would largely be conducted at the Clinical Center, with some additional NIAID support for work to be performed in the extramural investigator's laboratory. While collaborations with intramural investigators are allowed, it is not required. Moreover, projects that take only minimal advantage of Clinical Center resources would not be considered for NIAID support. For guidance on whether a project sufficiently utilizes CC resources, contact the CC Research contact in Section VII.

    For more information regarding this FOA, please refer to the NIAID FAQ webpage at: https://www.niaid.nih.gov/grants-contracts/opportunity-specific-questions-and-answers.

    The following will Not be supported by this FOA:

    • Select agent research
    • Multisite clinical trials
    • Phase 2b and above clinical trials
    • Research focused only on clinical samples or data
    • Research using animal models and/or "humanized" animals
    • On-going clinical trials
    • Research Projects without integrated mechanistic studies
    • Xenotransplantation studies
    • Studies of islet transplantation for treatment of Type 1 diabetes
    • Studies of hematopoietic stem cell transplantation (HSCT) unless HCST is a component of a study/therapy for primary immunodeficiency disease or organ transplantation
    • Studies requiring organ transplantation at the NIH Clinical Center
    • Research projects without significant Clinical Center utilization
    • Projects only utilizing banked samples or data
    • Studies that could easily be performed within existing academic medical centers or outpatient clinical facilities around the country

    Specific Areas of Research Interest

    Prior to submitting to this FOA, applicants are strongly encouraged to consult with the Scientific/Research contacts for the area of science for which they are planning to develop an application. Early contact (at least 12 weeks prior to submission or longer if IDE/IND is needed) is encouraged, especially with the contact for the NIH Clinical Center (NIAIDExpandCC@niaid.nih.gov). This period of time provides an opportunity for NIAID staff to discuss the scope and goals, and to provide information and guidance to the applicants.

    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
    Resubmission

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

    Clinical Trial?

    Optional: Accepting applications that either propose or do not 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.

    NIAID intends to fund up to 3 awards.

    Award Budget

    Application budgets need to reflect actual needs of the proposed project and may not exceed $400,000 direct cost per year. These funds may only be used to support the activities within the PD(s)/PI(s) (extramural scientists) research laboratory and exclude any Clinical Center or intramural costs, if applicable.  

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum period is five 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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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
    • Non-domestic (non-U.S.) Entities (Foreign Institutions)
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are  eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are  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.

    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:

    Kenneth Santora, PhD
    Telephone: 240-669-2933
    Email: NIAIDExpandCC@niaid.nih.gov 

    Page Limitations

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

    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

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

    The budget request for this FOA must distinguish between extramural costs and NIH Clinical Center costs. Extramural costs are associated with the extramural investigator and the applicant organization. NIH Clinical Center costs are costs to the Clinical Center that directly result from the proposed research project but should not be included in the proposed budget. It is expected that most of the costs of the research project will be absorbed by the Clinical Center.

    Because of the anticipated complexity of the budget information and the need to clearly delineate costs for the extramural awardee and potentially the intramural investigator (if applicable), applicants must submit a detailed R&R budget. Submission of a Modular Budget is NOT allowed for this FOA. Applications proposing a modular budget will not be reviewed.

    Extramural Grantee Costs

    Extramural costs may include such items as salary support for the extramural PD/PI and staff at the applicant organization, supplies, data analysis, and other allowable costs for work performed at the (extramural) applicant organization, as well as travel costs for the extramural investigator(s).  Extramural costs may also include travel costs for any patients not already at the NIH Clinical Center and other costs accrued by the extramural PD/PI such as the hiring of a full-time study nurse/coordinator for the work done at the Clinical Center.

    Intramural Investigator Costs

    Intramural scientist collaboration is allowable, but not required, in the FOA. Intramural investigator costs may include salary for contract staff to be specifically hired under a temporary appointment for the project, consultant costs, supplies, and other items typically listed under Other Expenses. Budget requests from the NIH intramural program may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs). Although the budget request may not include salary support for such individuals, it should indicate percent effort for any key personnel. Resources required to support intramural collaborations (excluding CC resources, see below), and any eligible costs (excluding CC costs, see below), need to be determined. The extramural applicant will enter this amount in the "Other" line in the budget section of the application and attach appropriate justification and documentation.

    NIH Clinical Center Costs

    Clinical Center costs include inpatient services, outpatient and day hospital services, pharmaceuticals, specialized research services, and other additional costs incurred by the Clinical Center as a result of the proposed research project. The budget for the Clinical Center costs should NOT be included in the application but need to be determined before the research protocol can be approved by the Clinical Center. 

    F&A (Indirect) Costs: Applicant organizations are reminded that Facilities and Administrative (F&A) or "indirect costs" are allowable for only the allowable extramural costs of the project. F&A will not be paid for any NIH Clinical Center services.

    Budget Justification: Detailed information about intramural investigator costs and NIH Clinical Center costs should be included in the narrative "Budget Justification" section.

    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 should describe the potential impact of the proposed research. The hypotheses and specific aims of the proposed research must be clearly and concisely stated.

    Research Strategy

    Overview:

    The applicant should include a clear and concise description, in narrative and diagrammatic form that depicts the interrelationships among the members of the team or group, their relevant experience/expertise, and the contribution of each to fulfillment of the goal of this FOA. Actual specification of clinical center partners is not necessary at the time of submission, however an outline of the necessary experience/expertise for the proposed research should be included.

    Applications for clinical studies:

    Research plans for clinical trials (Phase 0, I, or IIa) or clinical studies with associated mechanistic studies (clinical project) must be in the form of a detailed concept application, organized as specific aims, background and significance, preliminary studies, and research design, methods and study endpoints.

    Applications should be presented in sufficient detail to allow reviewers to judge significance, approach, innovation, and environment for the proposed clinical study. 

    Associated mechanistic studies:

    Descriptions of proposed mechanistic studies must include: identification of and rationale for the immune, genetic, and/or surrogate markers selected, including data from human studies; the source, quantity, quality and number of patient samples required; methodologies proposed to collect and analyze samples; and how the results of the proposed mechanistic studies will improve the capacity to utilize immune, genetic and/or surrogate markers to predict patient outcome, or will otherwise enhance our understanding of mechanisms of disease, or of therapeutic interventions.

    Collaboration with the NIH Clinical Center:

    The applicant must describe how the extramural team will establish and manage a productive collaboration with the NIH Clinical Center, what resources and assets from the NIH Clinical Center are needed to fulfill the goals and objectives of the project and how the team will make decisions and resolve any disputes.

    Organization:

    The applicant must include an organizational chart of the team or group showing the name, organization, and scientific discipline of the Principal Investigator and all key scientific, technical and administrative personnel. In addition, the applicant must document availability of personnel capable of performing and supporting administrative functions for the overall management of the applicant group and who will perform any regulatory support, data management and statistical analysis and trial monitoring.

    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:

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

    Letters of Support: Applications submitted in response to this FOA must include a current (i.e. within 3 months of application due date) letter from the Director of the NIH Clinical Center (NIAIDExpandCC@niaid.nih.gov) to confirm that the Clinical Center facilities will be able to accommodate the proposed research. Resubmission applications will need to obtain new letters of support. Applications submitted without this letter will be considered incomplete and will not be reviewed. Letters from the Clinical Center Director must be requested at least 6 weeks before application submission to allow time to confirm research accommodations.

    In addition, letter(s) from the collaborating intramural investigator(s) along with any other collaborators/consultants should also be included if applicable.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

    When involving 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:

    Section 2 - Study Population Characteristics

    2.7 Study Timeline

    If the research involves a clinical trial, a Milestone Plan must be included. If a planning stage is proposed by the applicant, final timeline and milestones will be negotiated post-award. The milestone plan must include a timeline for the following general milestones, as applicable:

    • ·    Completion of regulatory approvals and/or other significant interaction with regulatory agency (e.g., Pre-IND meeting);
    • ·    Enrollment of the first subject;
    • ·    Enrollment of 25%, 50%, 75% and 100% of the projected recruitment time period for all study subjects, including women, minorities and children (as appropriate);
    • ·    Completion of data collection time period;
    • ·    Completion of primary endpoint and secondary endpoint data analyses time period; Completion of final study report and publications; and
    • ·    Detailed protocol-specific performance milestones and timeline; these milestones may be negotiated at the time of the award, if appropriate.

    Section 3 - Protection and Monitoring Plans

    3.3 Data and Safety Monitoring Plan

    The DSM plan should be commensurate with the risk level of the proposed clinical research (see https://grants.nih.gov/grants/guide/notice-files/not98-084.html). All applications or study protocols must include a general description of the monitoring plan, policies,  procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB)), the Office of Biotechnology Activities (as appropriate), the Office of Human Research Protections, the Food and Drug Administration, and the Data and Safety Monitoring Board (if one is used).

    Section 4 - Protocol Synopsis

    4.2. Study Design

    4.2.c Interventions

    If appropriate to the study, a justification for the selection of the dose(s), frequency and administration of the intervention(s).

    4.4 Statistical Design and Power

    The statistical analysis plan is critical to knowing whether applicants have selected the correct cohort size based on proper power calculations and/or are using the most appropriate methods to analyze the resulting data and make correct conclusions at the end of the study. The ability to make conclusions of primary outcomes other than safety will be particularly important in small studies.

    4.6 Will the study use an FDA-regulated intervention?

    4.6.a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status

    Describe previous and planned interactions with the FDA on the proposed clinical trial. If the research involves an FDA regulated intervention, a statement addressing the need (if applicable) for IND/IDE approval from the FDA must be provided, including the date of submission and disposition of the IND/IDE application; if FDA staff have determined that IND/IDE approval is not required, a copy of the FDA letter/email stating no IND/IDE is required and the date of the decision.  In these cases, the IND/IDE must be in hand at the time of award; if needing assistance of the Clinical Center, then must be obtained within 6 months of award.

    Section 5 - Other Clinical Trial-related Attachments

    5.1 Other Clinical Trial-related Attachments

    A description of the data management and quality control plan, regulatory support plan, including methods for monitoring the quality and consistency of the intervention(s) and data collection; policies and methods for ensuring blinding of study results; and data confidentiality and subject privacy:

    Filenames must be unique within the application if multiple studies are proposed. For example, use "Clinical-Monitoring-Plan-Study-1.pdf" for the filename when attaching the Clinical Monitoring Plan in Study 1.

    Clinical Site Monitoring

    The filename "Clinical Site Monitoring.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. There is no page limit for this section, but applicants are urged to be succinct.

    Describe plans to conduct independent clinical site monitoring. Consult with the CC contact in Section VII.

    Regulatory Plan

    The filename "Regulatory Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. There is no page limit for this section, but applicants are urged to be succinct.

    Describe plans and capability to provide regulatory support for the development and implementation of the clinical trial.

    If a pre-IND meeting request was granted by the FDA, applicants must include the list of questions posed to the FDA and the official meeting minutes, if they are available. Applicants who requested an IND/IDE exemption must submit either: a copy of the letter that was sent to the FDA requesting an IND/IDE exemption for the proposed trial or a copy of the FDA letter granting an IND/IDE exemption letter for the proposed trial.

    Describe plans to comply with current FDA guidance, regulations for Electronic Signatures described in

    21 CFR Part 11, and predicate rules set forth in the PHS Act. Applicants are encouraged to also consider the FDA requirements for providing regulatory submissions in electronic format.

    Data Management Plan

    The filename "Data Management Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. There is no page limit for this section, but applicants are urged to be succinct.

    Include a description of the approach to data management and validation, including data management systems, methods of data entry and cleaning, event tracking and logistics, case report forms, and methods for monitoring the quality and consistency of the intervention(s) and data collection; policies and methods for ensuring blinding of study results; data confidentiality and subject privacy (without duplicating information in section 3.1 Protection of Human Subjects); adjudication of events (as needed); and data reports.

    If any of these documents are not available at the time of submission (as when a planning period is proposed), the applicant should attach a justification, and the Milestone Plan should address when these materials will be available.

    Delayed Onset Study

    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. 

    Foreign Institutions

    Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.

    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.

    If an award is made, the grantee will receive only the extramural costs and associated F&A. The NIH Clinical Center and the intramural investigator's costs (if applicable) associated with the research project will not be paid to the grantee, but instead will be supported directly by the NIH Institute/Center or The Clinical Center and these costs will not appear in the Notice of Award.

    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.

    In addition, for applications involving clinical trials: 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 impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

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

    Significance

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

    Specific to this FOA:  Does the proposed project promote optimal use of the NIH Clinical Center facility and assets through extramural-intramural partnership and collaboration? 

    In addition, for applications involving clinical trials: 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 the trial needed to advance scientific understanding?

    Investigator(s)

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

    In addition, for applications involving clinical trials: With regard to 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? 

    Innovation

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

    In addition, for applications involving clinical trials: 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 presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

    In addition, for applications involving clinical trials: 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?

    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 children, justified in terms of the scientific goals and research strategy proposed?  

    Environment

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

    In addition, for applications involving clinical trials: 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? 

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Study Timeline

    Specific to applications proposing 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)?

    Milestones (Clinical Trials only)

    Does the application present adequate milestones (or estimates when proposing a planning phase) with regard to completion of regulatory approvals, when applicable; timely enrollment of subjects; completion of data collection time period; completion of primary endpoint and secondary endpoint data analyses time period; completion of final study report?

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    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

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

    Select Agent Research

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources:

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

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIAID, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

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

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

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    • Utilization of NIH CC resources.
    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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as 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 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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

    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 Part 75, and other HHS, PHS, and NIH grant administration policies.

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

    The PD(s)/PI(s) will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.

    Awardees are responsible for identifying specific milestones that will be achieved during the project period.

    Awardees agree to participate in the overall coordination of research efforts. This participation includes collaboration and consultation with NIH investigators, and the sharing of information, data, and research materials, as appropriate and consistent with achieving the goals of the program.

    Awardees will interact with the NIH Clinical Center.

    Awardees will acquire an IND or IDE from the FDA if an investigational agent or device is to be used.

    Awardees will retain custody of and maintaining primary rights to data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

    The NIAID Project Scientist will have substantial involvement in the study and will be responsible for the normal scientific and programmatic stewardship of the award. The Program Officer and other NIAID staff will have decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues. Medical Officers within the Clinical center will provide support for medical and clinical site monitoring.

    The NIH reserves the right to phase out or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable protocol, (b) substantial shortfall in subject recruitment, consortium participation and collaboration with other awardees, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) human subject ethical issues that may dictate a premature termination, or (e) results that substantially diminish the scientific value of study continuation.

    Areas of Joint Responsibility include:

    Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what Clinical Center unique resources were utilized and the new intramural-extramural partnerships that developed. This will be evaluated by the program official/IC program director.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the awardee, an 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.

    T&C Inclusions and Modifications

    The Terms and Conditions of Award will include references to the currently approved versions of the Multiple PD(s)/PI(s) Leadership Plan, if applicable, and the Sharing Plans for Resources and Data.  Before the initial award is made, NIH and the awardees may negotiate changes or additions to the versions of these plans in the application. Future changes or additions to these plans may be developed by the NIH and the PD(s)/PI(s). Changes will be documented by an exchange of correspondence and the updated plans will become part of the Terms and Conditions of a revised Notice of Award.

    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)


    Clinical Center Contact:

    H. Clifford Lane, M.D.
    National Institute of Allergy and Infectious Diseases(NIAID)
    Telephone: 301-496-7196
    Email: CLANE@niaid.nih.gov

    Kenneth Santora, PhD
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-2933
    Email: ksantora@niaid.nih.gov

    Peer Review Contact(s)

    Dharmendar Rathore, PhD
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5058
    Email: rathored@niaid.nih.gov

    Financial/Grants Management Contact(s)

    Tina Carlisle
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone:  240-669-2947
    Email: tc48k@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.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.