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

Asthma and Allergic Diseases Cooperative Research Centers (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-AI-12-006

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-15-032

Companion Funding Opportunity

None 

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

93.855; 93.856    

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications from single institutions or consortia of institutions to participate in the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) program. The program will support centers that integrate clinical and basic research to conduct studies on the mechanisms underlying the onset and progression of diseases of interest, including asthma, rhinitis (allergic and non-allergic), chronic rhinosinusitis, atopic dermatitis, food allergy, and drug allergy.  The overarching goal of the program is to improve the understanding of the pathogenesis of these conditions and to provide a rational foundation for new, effective treatments and prevention strategies. 

Key Dates
Posted Date

June 3, 2015

Open Date (Earliest Submission Date)

September 2, 2015  

Letter of Intent Due Date(s)

September 2, 2015  

Application Due Date(s)

October 2, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2016  

Advisory Council Review

May 2016  

Earliest Start Date

July 2016 

Expiration Date

October 3, 2015  

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.


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

This Funding Opportunity Announcement (FOA) invites applications from single institutions or consortia of institutions to participate in the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) program. The program will support centers that integrate clinical and basic research to conduct studies on the mechanisms underlying the onset and progression of diseases of interest including asthma, rhinitis (allergic and non-allergic), chronic rhinosinusitis, atopic dermatitis, food allergy, and drug allergy.  The overarching goal of the program is to improve the understanding of the pathogenesis of these conditions and to provide a rational foundation for new, effective treatments and prevention strategies.

Background

Asthma and allergic diseases are major causes of illness and disability in the United States and the prevalence of these conditions is still on the rise.  Also of high prevalence and morbidity are chronic rhinosinusitis and non-allergic rhinitis, which share pathophysiologic and clinical characteristics with allergic diseases. In all these conditions, major gaps exist in our understanding of their immunopathophysiology and, for most of them, management is either based on avoidance of allergens or utilizes pharmacologic interventions that either offer only symptomatic relief or have nonspecific anti-inflammatory activities that do not alter the natural history of the disease. Allergen immunotherapy for food and aeroallergens or early dietary introduction of food allergens offer promise in disease modification and prevention, but require further studying.

  • Asthma affects 8-9% of the U.S. population (approximately 25 million people) and 9.6% of children. Severe asthma affects 5-10% of all patients with asthma, is poorly understood, and has a much higher economic burden when compared with mild and moderate disease.
  • Allergic rhinitis is estimated to affect approximately 60 million people in the U.S. and non-allergic rhinitis at least another 30 million.  Large numbers of patients with these conditions do not achieve adequate relief with available medications. Non-allergic rhinitis presumably includes a number of distinct syndromes, but no systematic research has been conducted to determine the correct endotypes, a necessary step towards rational development of therapeutic approaches. 
  • Chronic rhinosinusitis, a persistent inflammatory disease of the nasal and sinus mucosa, is difficult to manage pharmacologically; as a result, it leads to roughly 15 million physician visits and 200,000 sinus surgical procedures each year.  The causes of this condition are unknown. 
  • Atopic dermatitis affects approximately 12% of children under age 18 and 1% to 3% of adults in the U.S.  Despite the strong phenomenological relationships, the role of allergy in atopic dermatitis and the etiologic and pathophysiologic interactions between atopic dermatitis and food or respiratory allergy have not been elucidated. 
  • Food allergy affects about 6 to 8% of children under the age of 4, and about 3-4% of adults. Food allergy is the most frequent single cause of emergency room visits for anaphylaxis and accounts for 34 to 52% of these visits. Recent studies indicate that prevention and management of food allergy with early allergen exposure or with allergen immunotherapy, respectively, are possibilities requiring further exploration. 
  • Allergic drug reactions are defined for the purpose of this FOA as reactions that have an immunologic component.  Allergic drug reactions result in significant morbidity, particularly in patients with underlying serious conditions who are in need of the drug in question. The exact mechanisms of many allergic drug reactions have not been determined. Better understanding of the pathogenesis of these reactions may facilitate prediction and prevention or may guide the development of drugs with less allergenicity.

Both innate and adaptive immune responses participate in the pathogenesis of allergic diseases. It is well established that environmental exposures in early childhood contribute significantly to the expression of many of these diseases later in life. These exposures involve not only allergens, but other inducers of immune responses possibly including bacteria, viruses and natural adjuvants. Some of these inducers are environmental pollutants. It is now known that some of these exposures are protective against allergic disease, but much remains to be learned as to the mechanisms of protection.  Interaction of early exposure to these factors with an individual's genetic makeup shapes the development of the immune system and together determine the risk for allergic disease.  Recent advances raise the possibility that epigenetic modifications also play a role in controlling the function of the immune system and that these modifications are also influenced by environmental exposures.    

Allergen specific immunotherapy trials with food and aeroallergens can reduce responsiveness to the allergens in question, a protective effect that can also be sustained after discontinuation of treatment.  A recent large trial has shown substantial reduction in the occurrence of peanut allergy with early introduction and maintained exposure of peanut-containing food in high-risk infants.  Older studies have suggested that allergen immunotherapy in children with allergic rhinitis can prevent the development of asthma. Thus, evidence exists that allergy prevention is possible. However, improvements in allergen immunotherapy are necessary to increase its tolerogenic effectiveness and reduce the duration of treatment while further improving its safety profile. New forms of immunotherapy are under development and require testing.

The NIAID AADCRC program, established more than four decades ago as the first targeted research program in the field of asthma and allergic diseases, is the cornerstone of NIAID's efforts to promote innovative, multidisciplinary clinical and basic research on these diseases. Supported by a multi-project mechanism, the program aims to leverage expertise provided by centers around the U.S. through collaborations among researchers. The program currently supports 11 AADCRC U19s.

Research Objectives and Scope

The objective of this FOA is to support multidisciplinary and multi-project research on the immunopathophysiology of asthma, rhinitis (allergic and non-allergic), chronic rhinosinusitis, atopic dermatitis, food allergy, and drug allergy.  The overall goal of the AADCRC program is to improve the understanding of the pathogenesis of these conditions and to provide a rational foundation for new, effective treatments and prevention strategies. 

Highly integrated and synergistic research programs are encouraged for the AADCRC program. This includes multi-institutional applications for conditions of interest to this FOA, especially where research resources are limited (e.g. non-allergic rhinitis or drug allergy). Research programs could be organized around either:

  • immunologic mechanisms/pathways that are hypothesized to be an important pathobiologic process in a condition of interest to this FOA or
  • one or more clinical trials or clinical studies that test a novel therapeutic approach, mechanistic hypothesis or aim at elucidating disease phenotypes and endotypes in a condition of interest to this FOA.

NIAID programmatic priorities for this FOA are:

  • The role of innate and adaptive immune functions in the development and pathogenesis of asthma and allergic diseases with focus on severe asthma, chronic rhinosinusitis, atopic dermatitis and drug allergy;
  • The impact of the microbiome and pollution on immune responses as they pertain to the development, prevention and management of asthma, allergic rhinitis, food allergy and atopic dermatitis;
  • The interaction between infections and atopy and the role of immune responses to infections in the development and exacerbations of asthma, allergic rhinitis, chronic rhinosinusitis and atopic dermatitis;
  • Induction of and understanding of the mechanisms of desensitization and sustained tolerance for the treatment and prevention of asthma, allergic rhinitis, food allergy and drug allergy;
  • Genetic variations and epigenetic alterations affecting host immune responses to aeroallergens, food allergens and drug allergens;
  • Clinical, immunologic and physiologic phenotyping and endotyping of drug allergy, atopic dermatitis, chronic rhinosinusitis and non-allergic rhinitis syndromes;

Applications including the following types of studies will be considered non-responsive and will not be reviewed:

  • Research on autoimmunity and autoimmune diseases.
  • Research on primary immune deficiency diseases.
  • Demonstration and Education Research Projects.
  • Phase III clinical trials.
  • Continuation of ongoing (active) clinical trials. The applicant will be allowed to propose only new clinical trials.  For the purpose of this FOA, a new trial is defined as one that has not previously recruited any subjects.
  • Applications in which the majority of proposed research involves animal models.
  • Research on HIV or AIDS

In order to stress the integration and focus of the applications on human disease, the majority of the proposed research within each application should be defined as NIH human subjects research (for the NIH definition of human subjects research, please see the NIH Office of Extramural Research Human Subjects website  or utilize human material (including primary human cells, biologic samples, and clinical data). Studies using only transformed human cell lines will not count toward this requirement. Some animal research may be included on the basis of the need for experimentation that is not possible in humans or with human materials. However, the animal studies should be clearly integrated into a plan that will translate animal findings to human diseases. 

AADCRC Research Programs funded under this FOA will be comprised of multiple components to carry out the broad scope of research delineated above. Component projects and cores within a single application should not only relate to a central theme relevant to the specified diseases of interest, but also relate to the other components within the same application. The components of an application include:

Administrative Core: Each application should provide for an Administrative Core headed by the contact PD/PI of the application who is responsible for the overall management, communication, coordination and supervision of the Program.

Research Projects: Each application must contain at least two research projects organized around a common theme or hypothesis, with demonstrated synergy among the research projects, administrative core and service cores (if proposed).  The majority of the proposed research should meet the NIH definition of Human Subjects research or utilize human material.

Service Core(s): Service cores, such as, but not limited to, a Clinical Core, or a Data Management and Analysis Core, may be proposed if they support the Center as a whole and directly support at least two of the proposed research projects.  

Infrastructure and Opportunity Fund (IOF) Management Core: A single Infrastructure and Opportunity Fund of up to $500,000 total costs per year will be established under this FOA to support new and pilot research projects led by early stage investigators within the AADCRCs, as well as for the development of resources that the AADCRC Steering Committee may deem necessary. All applications must include a Core that will have the responsibility of administering the AADCRC IOF. After awards have been made, one AADCRC awardee institution will be selected by the NIAID to manage the IOF for the entire AADCRC program.  This institution must agree to take responsibility for managing the IOF, including fund disbursement, administration, and reports. Management of the IOF will involve:

  • Establishing an administrative structure to manage the IOF
  • Disbursing and tracking IOF funds under the direction of the Steering Committee
  • Implementing plans for interacting with the institutions that will receive IOF funds, including establishing consortium agreements, when applicable
  • Establishing procedures, formats, and timelines for reporting on the status of IOF projects and expenditures to the NIAID and the AADCRC Steering Committee

Steering Committee

Program Directors /Principal Investigators (PDs/PIs) funded under this program will form a Steering Committee after award. The Steering Committee will serve as the main governing body for the cooperative group. Among other responsibilities, it will identify scientific opportunities, emerging needs and impediments; develop guidelines for the publication of collaborative research project results, prepare cumulative progress reports if requested by the NIH Program Officer(s), participate in quarterly Steering Committee teleconferences, and annual face-to-face meetings in conjunction with the annual AADCRC scientific meeting.

Potential applicants are strongly encouraged to consult with the Scientific/Research Contact listed in Section VII during the early stages of preparation of the application.    

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.

Application Types Allowed

New
Renewal - While NIAID will not make an award to institutions that are currently funded under the previous version of this FOA, RFA-AI-12-006, renewals will be accepted from applicants funded from RFA-AI-10-013.

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

Funds Available and Anticipated Number of Awards

NIAID intends to commit $10.8 million in FY 2016 to fund 6-7 U19 awards and the Infrastructure and Opportunity Fund (IOF).

Award Budget

Application budgets are limited to $900,000 in direct costs per year (excluding consortium F&A costs) and need to reflect the actual needs of the proposed project.

Award Project Period

The total project period for an application submitted in response to this FOA will be five years. 

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

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

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

Note that the multiple PD(s)/PI(s) option may be used only for the Overall Program.  Projects are limited to a single project lead per project and a single core lead per core within the multi-component application.

An investigator can serve as a PD/PI on only one AADCRC award or application. This includes all PD(s)/PI(s) of a multiple-PD/PI application. In single PD/PI applications, the PD/PI must also serve as a Project Leader, and is required to commit an overall minimum of 3 person months in AADCRC activities. In multi-PD/PI applications, every PD/PI must serve as a Project or Core Leader with at least one of the PD(s)/PI(s) serving as a Project Leader and committing an overall minimum of three person months in AADCRC activities.

Note that the current FOA will not allow foreign clinical trial sites.  

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. 

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).

NIAID will not accept applications from institutions that are currently funded under the previous version of this FOA, “RFA-AI-12-006.”   

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

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Louis A. Rosenthal, Ph.D.
Telephone: 240-669-5070
Email: rosenthalla@mail.nih.gov
 

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core (use for Administrative Core)

6

Core (use for Service Cores and IOF Management Core)

6 each

Project (use for Research Projects)

12 each

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required; 1
  • Administrative Core: required; 1
  • IOF Management Core: required; 1
  • Service Cores: optional, no minimum or maximum, but each Core must support at least two Research Projects
  • Research Projects: required; minimum of 2
Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Program. Concisely and realistically describe the hypothesis or hypotheses to be tested. 

Research Strategy:  This narrative section summarizes the overall research strategy for the multi-component application.  The multi-component application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problem. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique. To highlight program synergy, applicants may describe in the Overview section how the individual components will be coordinated and work together to address the overall goals and aims of the program. Include a schematic overview of the interactions and collaborations among the components, and indicate collaborations among members and relevant publications co-authored by members of the program. Program synergy may also be addressed in other sections of the application, as appropriate.

As part of the Overall Research Strategy, describe the focus of the research program in this application. In order to achieve this FOA’s objective of supporting highly integrated and synergistic research programs focused on a central theme relevant to the specified diseases of interest, it is recommended that applications be drafted along the lines of either of the two models provided below.

  • MODEL A – Pathway Focus

    The application focuses on the role of an immunologic mechanism/pathway that is hypothesized to be an important pathobiologic process in a condition of interest, as specified in this FOA, or in allergy, in general.  This mechanism/pathway may involve a single molecular species or several interrelated species, selected genes, a cell type, a micro-organism or a group of micro-organisms, an environmental factor or a group of environmental factors (such as allergens, microbes or pollutants). The application should include projects that examine this pathway from various perspectives including clinical studies or clinical trials, genetics, systems biology approaches, in vitro work, and animal models. The majority of the proposed research should utilize human material (including primary human cells, biologic samples, and clinical data).  For example, if human subjects research and animal research are to be separated into different projects, more than half of the projects within the research program should be defined as NIH human subjects research or utilize human material. If human subjects research and animal research are mixed within all projects, more than half of the specific aims in each project should be defined as NIH human subjects research or utilize human material. 
  • MODEL B – Clinical Intervention/Observation Focus

    The application is centered around one or more clinical trials (interventions) or clinical studies (cross-sectional or short-term longitudinal observational studies, genetic studies) that test a novel therapeutic approach, a novel mechanistic hypothesis, or aim at elucidating disease phenotypes and endotypes in a condition of interest to this FOA. The clinical trial(s) or study(ies) constitute the source of material that supports the conduct of a series of associated studies that test the central hypothesis of the application in a comprehensive manner. The application should include projects built around the clinical trial(s) or observational study(ies) including mechanistic studies, systems biology approaches (including genomics, epigenomics, metabolomics, etc.), microbiome studies or genetics. As in MODEL A, animal models may be utilized in parallel to the clinical trial(s) or observational study(ies), only if they provide more in-depth hypothesis testing on outcomes that cannot be assessed with human research. As in MODEL A, such animal studies should represent the minority of the overall application.

If the application is a renewal, this section should also highlight past performance and the major accomplishments from the prior funding period. For individual research projects and cores that will be continued as part of a renewal application, additional details of progress made during the prior funding period should be provided in the Research Strategy within each research project and core.  

If you choose to appoint a Program Advisory Committee (optional), describe the expertise and responsibilities of your potential Program Advisory Committee members. For a new application, if applicable, do not contact, recruit, or name potential members. For a renewal application, provide the names only of current members.   

Letters of Support: Provide any institutional letters of support specific to the Overall Component.

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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core ’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions. Human Subjects are not applicable to the Administrative Core and applicants should answer “No” to the question “Are Human Subjects Involved?”

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question. Vertebrate Animals are not applicable to the Administrative Core and applicants should answer “No” to the “Are Vertebrate Animals Used?” question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)
  • ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
  • Multiple Core Leads are NOT permitted for the Administrative Core. 
Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Funding for the overall administrative efforts, including administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses, should be requested in this core.

All applications should include travel funds for the PD(s)/PI(s) to participate in annual Steering Committee meetings, and PD(s)/PI(s) and subproject PD(s)/PI(s) to attend the annual AADCRC scientific meetings. The two-day scientific meeting will be held each year in Bethesda, Maryland.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: List in priority order the proposed activities and services of the Administrative Core. Concisely and realistically describe the work to be completed to address issues of program coordination, communication, and management. 

Research Strategy: A fully-developed and well-described Administrative Core plan is required.  Describe the organizational and administrative structure of the proposed multi-component application.  Include plans on how the PD(s)/PI(s) will interact with Project Leaders and whether and how the Center research projects will be supported by external consultants. Provide an administrative plan that includes a discussion of the structure and roles of administrative staff, including the functions to be performed; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research related travel and training will be managed. No research data management and data analysis should be included in the Administrative Core.  

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..

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Administrative Core)

Not Applicable 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

Not Applicable

Infrastructure and Opportunity Fund (IOF) Management Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (IOF Management Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (IOF Management Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (IOF Management Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions. Human Subjects are not applicable to the IOF Management Core and applicants should answer “No” to the question “Are Human Subjects Involved?”

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question. Vertebrate Animals are not applicable to the IOF Management Core and applicants should answer “No” to the “Are Vertebrate Animals Used?” question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (IOF Management Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (IOF Management Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used
  • Multiple Core Leads are NOT permitted for IOF Management Core.

Budget (IOF Management Core)

Budget forms appropriate for the specific component will be included in the application package.

Funds supported by the IOF will be administered by one recipient organization selected by the NIAID.  When applicable, the recipient organization will fund the IOF projects through consortium agreements in accordance with the policies outlined in the NIH Grants Policy Statement.  The proposed budget for the IOF Management Core should only include funds for an administrator with a maximum effort of .5 calendar months per year.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (IOF Management Core)

Specific Aims: List in priority order the proposed activities and services of the IOF Management Core. Concisely and realistically describe the work to be completed to address issues of program communication and fiscal management.    

Research Strategy: The IOF management plan must include:

  • an administrative structure;
  • proposed methods/procedures to support the Steering Committee in funds disbursement, reporting, and monitoring (e.g. time interval for establishment and renewal of subcontracts, invoices to be paid, and plans for handling subcontract administration delays);
  • plans for interacting with the institutions that will receive IOF funds.

The research strategy section for the IOF Management Core applies only to the management of the IOF and this section should NOT include any IOF proposed research projects.

Letters of Support: Provide documentation of institutional commitment to the administration of the opportunity fund.

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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (IOF Management Core)

Not Applicable 

PHS 398 Cumulative Inclusion Enrollment Report (IOF Management Core)

Not Applicable

Service Core

When preparing your application in ASSIST, use Component Type ‘Core.’

Service Cores may include, but are not limited to, a Clinical Core, or a Data Management and Analysis Core. If the application proposes to conduct more than one clinical trial or clinical study, a Clinical Core may be proposed. This Core will be responsible for the organizational and regulatory aspects of the clinical trials and studies and may include data administration and analysis functions; alternatively, data management and analysis may be conducted under a separate Data Management and Analysis Core.

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

SF424 (R&R) Cover (Service Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Service Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Service Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Service Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Service Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used
  • Multiple Core Leads are NOT permitted for Service Cores.
  • NIAID highly recommends inclusion of Core personnel whose role will be to ensure timely submission of data and data analysis obtained under this award to the ImmPort database or to other public portals designated by NIAID. 

Budget (Service Core)

Budget forms appropriate for the specific component will be included in the application package.

The percentage of total funds that will be required to support each component research project that will utilize the core should also be presented. This information should be included in the core’s budget justification for Year 1.

For all clinical trials (but not for the clinical studies), NIAID will provide a Data and Safety Monitoring Board (DSMB) or a Safety Monitoring Committee (SMC). Therefore, the applicant does not need to include or budget for DSMB expenses.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Service Core)

Specific Aims: List in priority order the broad, long-range activities and services of the proposed Core. In addition, state the Core’s relationship to the program’s goals and how the Core relates to two or more individual research projects in the application.   

Research Strategy:  
Use this section to describe how the proposed Core activities will contribute to meeting the Program’s goals and objectives, and explain why the core resources are not otherwise available. In addition, this section should indicate the relevance of the Core to the primary theme of the application. The application must indicate the specific projects to be served by the Service Core(s). The activities of Service Cores must not overlap with those of a proposed project. Include a clear description of the facilities and techniques to be provided by the Service Core and describe the interactions of the Core Lead and each of the Scientific Projects.

Letters of Support: Provide any letters of support from collaborators that are specific to the Service Core.

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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report (Service Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Service Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Research Project

When preparing your application in ASSIST, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
  • Multiple Project Leads are NOT permitted for Research Projects.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

If the project involves a clinical trial or a clinical observational study, the applicant is responsible for including the costs of all support for statistical design, data collection, analysis and management, as well as the costs for clinical site monitoring, medical monitoring, project management and quality assurance of the proposed clinical trials or observational clinical studies in the application budget. Alternatively, these costs can be incorporated into the budget of relevant Service Core(s), provided that specific cross-references are made to clarify how these necessary functions will be supported. If NIAID decides that these functions should be assigned to an independent data and statistical coordinating center, the cost of these functions will be covered by a separate NIAID-funded, independent entity and the AADCRC application proposed budget will be adjusted accordingly pre-award.

For all clinical trials (but not for the clinical studies), NIAID will provide a Data and Safety Monitoring Board (DSMB) or a Safety Monitoring Committee (SMC). Therefore, the applicant does not need to include or budget for DSMB expenses.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

 Specific Aims: List, in priority order, the broad long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the individual research project's relationship to the Program’s goals and how it relates to other projects or cores.

Research Strategy:  Use this section to describe how the proposed research will contribute to meeting the Center’s goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.

Clinical research
The majority of research proposed should meet the NIH definition of human subjects research or utilize human material and should involve individuals with one or more of the conditions of interest named in this FOA, or clinical specimens from such individuals. Healthy volunteers may be included in proposed clinical studies only as controls. Clinical trials, if proposed, are limited to Phase I or Phase II trials.  See the section below, “Clinical trials”, for detailed NIH definition of clinical trials.  Studies using human specimens obtained from relevant ongoing or completed clinical studies or clinical trials may also be proposed.  

Applicants are advised that, in the event their application receives NIAID funding, any proposed clinical trials will be reviewed by various review bodies per NIAID clinical trial regulations and will most likely undergo substantial modifications.  This will include reviews by the Medical Monitor and Project Manager that the NIAID will assign to the study, review by the NIAID Division of Allergy, Immunology and Transplantation (DAIT) Clinical Research Committee, and review by the DAIT Asthma and Allergy Data and Safety Monitoring Board (DSMB) or Safety Monitoring Committee (SMC). 

Clinical trials
The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (http://grants.nih.gov/grants/glossary.htm#ClinicalTrial). Research with human subjects to develop or evaluate clinical laboratory tests (imaging or molecular diagnostic tests) might be considered as a clinical trial if the test will be used for medical decision-making, or if the test itself imposes more than minimal risk for subjects.

In the spirit of the above definition, any study that involves interventions aiming at understanding mechanisms of disease (e.g. allergen challenges, experimental exposure of humans to an inflammatory mediator or to a rhinovirus), or any study that involves an intervention for which the FDA will require an IND/IDE application will be considered a clinical trial. In general, a clinical trial should be presented as an individual project of the U19 application. If two trials are highly related and share most aspects of study design, they can be presented within the same individual project.

The Approach section of all clinical trial projects must address the following aspects of the proposed trial(s) in the following order and utilizing the following sub-headings:

  • Study Title
  • Study objectives (primary and secondary) 
  • Study population(s)
  • Proposed clinical study site(s) (Note: foreign clinical trial sites are not allowed in this FOA)
  • Intervention and comparators (if any)
  • Investigational drugs and/or devices
  • Study design:
  • Inclusion/exclusion criteria
  • Randomization/stratification plan
  • Number of subjects
  • Anticipated duration of recruitment
  • Total study duration and timeline
  • Primary endpoints/outcomes
  • Secondary endpoints/outcomes
  • Study visit schedule and primary evaluations, including laboratory evaluations
  • Sample size justification
  • Any proposed sub-studies
  • Statistical analyses and data analyses plans and management
  • Study feasibility:
  • Experience and ability of the investigator’s team to prepare an IND/IDE application for this trial, if needed
  • Availability of and access to the appropriate type and number of study participants
  • Experience and expertise of each proposed clinical trial site in executing the proposed clinical trial and its procedures
  • Plans and anticipated problems for subject recruitment and retention, as well as proposed approaches to overcome or minimize such problems
  • Study organization: a plan for the management of the clinical trial that includes description of personnel involved in conducting the trial, personnel involved in data entry and management, personnel involved in statistical analysis and personnel involved in safety monitoring; the interactions between these teams should be described

Clinical studies
For applications proposing one or more clinical studies (observational studies with no-interventions and involving only minimal risk procedures), the Approach section of all clinical study projects must address the following aspects of the study in the following order and utilizing the following sub-headings:

  • Study title
  • Primary hypothesis to be tested
  • Study objectives (primary and secondary)
  • Study population(s) with clear description of clinical phenotypes
  • Proposed clinical sites (if study is planned or ongoing at the time of award)
  • Key design features, including primary and secondary endpoints, comparison/control groups
  • Sample size calculations and statistical analyses plans
  • Study duration and timeline (where samples are derived from planned clinical studies, or studies ongoing at the time of award)
  • Description of mechanistic studies.
  • Description of source and quantity of samples to be obtained, and discussion of potential safety and ethical issues involved in obtaining the samples.
  • Study feasibility:
  • Availability of and access to the appropriate type and number of study participants
  • Experience and expertise of each proposed clinical trial site in executing the proposed clinical trial and its procedures (including the ability to obtain the samples required for the proposed study)
  • Plans, anticipated problems, and proposed approaches to overcome or minimize such problems, for subject recruitment and retention (for planned or ongoing studies)
  • Basic science site(s) proposed to participate and their experience and expertise in conducting the laboratory work required

Projects obtaining human samples from non-AADCRC-supported clinical studies or trials

For projects that plan to obtain human samples derived from clinical studies or clinical trials that are planned, ongoing or completed and are or have been sponsored by sources other than the AADCRC, the information in the Approach section should include the following:

  • Study title
  • Study objectives (primary and secondary)
  • Study population(s) with clear description of clinical phenotypes
  • Key design features, including primary and secondary endpoints, comparison/control groups
  • Sample size calculations and statistical analyses plans as they pertain to the questions posed by the AADCRC study that will utilize the parent study/trial samples
  • Study duration and timeline (if a planned or an ongoing study)

Documentation of the ability to acquire human samples, including written agreements between the PD(s)/PI(s), the applicant institution, the clinical study/trial sponsor(s), including drug companies, if applicable, and the IND/IDE sponsor (if not one of the above) to be used in the studies proposed by the application. This documentation should be supplied in the form of Letter(s) of Support.

Non-clinical research
Describe the research design conceptual procedures, and analyses to be used to accomplish the specific aims of the project. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss associations with clinical project(s). Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project.

Protection of Human Subjects:

Clinical Trials: For all clinical trials (but not for clinical studies) the following information is required and should be presented in the Protection of Human Subjects section:

  • Listing of all interventional agents (FDA approved or not) to be used in the trial with anticipated adverse experiences
  • Methods for adverse event identification, recording and reporting (including serious adverse events and unexpected events)
  • Plan for independent clinical monitoring of the trial (including site monitoring visit schedule and content)
  • Individual subject and study stopping rules

For all clinical trials that will be conducted, NIAID will provide a Data and Safety Monitoring Board (DSMB) or a Safety Monitoring Committee (SMC).

Clinical Studies: For all clinical studies, the following information is required and should be presented in the Protection of Human Subjects section:

  • Methods for adverse event identification, recording and reporting (including serious adverse events and unexpected events)
  • Individual subject and study stopping rules

Letters of Support: Provide letters of support from collaborators that are specific to the research projects.

For Projects obtaining human samples from non-AADCRC-supported clinical studies or trials, documentation of the ability to acquire human samples, including written agreements between the PD(s)/PI(s), the applicant institution, the clinical study/trial sponsor(s), including drug companies, if applicable, and the IND/IDE sponsor (if not one of the above) to be used in the studies proposed by the application is required. A statement is required that the subjects from whom samples were obtained from the parent clinical study/trial not supported by the proposed AADCRC project have given informed consent/assent and the material they have provided can be used by the AADCRC project.

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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report (Research Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Research Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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.

Important reminders:
All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). 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 NOT-OD-13-030.

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.

Overall Impact - Overall

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).

Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific and technical merit, and in providing an overall impact score, but will not give separate scores for the individual items.

  • Is the research proposed by the Center as a whole scientifically compelling?
  • Are there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the Center?
  • Are the overall Center goals significant and focused on studies that meet the overall objectives of the FOA as well as objectives pertaining to diseases of interest that this FOA identifies? Will the integration of the individual projects into a single Center be more beneficial than pursuing each project independently?
  • Do(es) the PD(s)/PI(s) have the leadership and scientific ability to develop an integrated and focused research Center?
  • Will the PD(s)/PI(s) and other Project/Core Leaders devote adequate time and effort to the Center?
  • Is there adequate evidence of sufficient institutional support for the PD(s)/PI(s) in terms of laboratory space, equipment and other resources?
  • For applications designated multiple PD(s)/PI(s), is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PD(s)/PI(s)?
  • Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed Center? 
  • Is the management plan for fiscal accountability and communication within the Center appropriate? 
  • Are the plans for coordination, communications, problem identification and resolution, and the establishment of a strong collaborative environment for the Center appropriate?
  • For renewal applications, have the Center's accomplishments made a major impact on the field or successfully achieved their original goals?
Overall Impact - Individual Research Projects

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 - Individual Research Projects

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? 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? Is the rationale for the relevance of the proposed animal models to human asthma and/or allergic diseases sound and with high scientific merit? If a clinical trial(s) is proposed, is there potential for the clinical trial to significantly advance the prevention and/or treatment of asthma and/or allergic diseases or to provide mechanistic information that will facilitate the development of new therapeutic approaches? 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project ? If Early Stage Investigators or New Investigators, or 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? Does the clinical project team have both the expertise/capabilities and demonstrated experience to support the clinical research activities proposed in the U19 application as a whole? Does the clinical project team have the experience and expertise to guide and/or assist in the development and preparation of documentation required for clinical research as well as experience with regulatory activities, including IND/IDE submissions, recruitment and retention of study participants, medical monitoring, and safety oversight and reporting?  Do the investigators commit adequate effort to successfully fulfill the proposed projects’ needs?  

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project ? 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?

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?  If a clinical trial(s) is proposed, are the selection of the study population, the applicant’s plans for managing the proposed trial, including management and reporting of study data and monitoring safety, and the timeline for protocol development and implementation, plans for preparation of an Investigational New Drug or Investigational Device Exemption application, and plans for recruitment and retention of study participants sound and feasible? Are the applicant’s overall approaches to overcoming obstacles and limitations sound and feasible?  If animal studies are included, is the choice of animal model justified in relation to what can be achieved using human data?  

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?   

Overall Impact –Administrative and Service Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core to exert a sustained, powerful influence on the research field(s) involved.

Review Criteria – Administrative and Service Cores

Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of scientific merit and provide an overall impact score for each Core, but will not give separate scores for these items.

Administrative Core
  • Are the staffing and administrative plan appropriate to facilitate attainment of the objectives of the proposed program? Are the experience, level of commitment, and availability of the Core Leader adequate to manage the core and the overall program?
  • Is the plan to organize communications, group meetings, and teleconferences adequate and appropriate? Are the plans for coordination, problem identification and resolution, and establishment of a strong collaborative environment for the program appropriate?
  • Are the plans for resource allocation within the program adequate and appropriate?
  • Is the management plan for fiscal accountability and communication within the program appropriate?
  • Are the plans for communication and collaboration with other AADCRC centers adequate?
Service Core(s)
  • Is provision of the proposed core services to two or more Research Projects critical and justified?
  • Is the relationship of the core to the central scientific theme of the overall program strong?
  • Are the quality of the relevant facilities or services provided (including procedures, techniques, quality control) and criteria for prioritization of usage appropriate?
  • Are the proposed personnel appropriate to lead and staff the core? Is the commitment of the Core Leader and other staff sufficient? Are the experience, level of commitment, and availability of the Core Leader adequate to manage the core?
  • Does the clinical core leader have both the expertise/capabilities and demonstrated experience to support the clinical research activities proposed in the U19 applications?
  • Does the core leader have the experience and expertise to guide and/or assist in the development and preparation of documentation required for clinical research as well as experience with regulatory activities, including IND/IDE submissions, recruitment and retention of study participants, medical monitoring, and safety oversight and reporting?
  • Is there sufficient effort and expertise dedicated to both data management and oversight of  data sharing policies?
  • Is there sufficient bioinformatics infrastructure to support the proposed activities?
  • If support is proposed for study design and statistical analyses, are sufficient effort and expertise included in the core? 
Additional Review Criteria - Overall, Research Projects, Cores

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations- IOF Management Core

Reviewers will consider each of questions below for the IOF Management Core, in the determination of scientific merit and rate the core Acceptable or Unacceptable, and will not consider the evaluation of the core in providing an overall impact score for the application.

 
  • Is provision of the proposed core services to the AADCRC program described in sufficient detail?
  • Is sufficient justification provided for the management methods proposed?
  • Are the personnel charged with managing the IOF appropriate?
Additional Review Considerations - Overall, Research Projects, Cores

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

Applications from Foreign Organizations

Not Applicable 

Select Agent Research

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

Resource Sharing Plans

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

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.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National 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.  
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

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.

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.

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 as a whole, 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:

  • PDs/PIs will determine and coordinate the scientific and administrative activities of the approved projects; set project goals and timelines; accept and implement common guidelines approved by the Steering Committee. Principal Investigators must agree to Documentation of Commitment to the Collaborative Group. This is a written commitment, signed by the Principal Investigator and the applicant institution, to participate in the cooperative research program, including serving on the Steering Committee, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIH staff in accordance with the guidelines described in the NIH staff responsibilities in these Terms and Conditions of Award.
  • To promote rapid public access to AADCRC-supported data, NIAID expects that all AADCRC investigators will share their AADCRC-supported data publicly through ImmPort (https://immport.niaid.nih.gov) or other public portals designated by NIAID. The privacy of participants will be safeguarded and confidential and proprietary information will be protected. After award and prior to data collection, data set definitions and schedules for data sharing will be negotiated between each center and their Program Officer, as will plans for other resource sharing. If further schedule changes are needed throughout the funding period, they will be negotiated with NIAID after evaluation by the Steering Committee.  Sharing plans represent a commitment by the applicant institution (and its subcontractors, if any) to support and abide by the plan.  The PD/PI will establish procedures within the center to ensure that all members of that center, including any scientists added via IOF support, conform to the data-sharing and other resource-sharing plans.  

Clinical Research Responsibilities
The PD(s)/PI(s) is responsible for ensuring that, in accordance with NIH clinical research policy and the NIAID Clinical Terms of Award, all clinical trials performed through the AADCRC must be conducted in accordance with the International Conference on Harmonization (ICH) Good Clinical Practices and applicable Federal regulations. The PD(s)/PI(s) will ensure that all individuals involved in clinical research projects provide current GCP certification prior to project initiation.

1. Protocol Development, Review and Approval
a. Protocol Development. After awards are made, AADCRC Principal Investigators will fully develop the clinical research protocols for projects supported by this FOA with the participation of the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) staff. AADCRC protocols will utilize the protocol templates provided by NIAID.

b. Protocol Review and Approval. The AADCRC PD(s)/PI(s) will provide all clinical research protocols to NIAID for review and will not implement the protocol until all NIAID approvals are obtained and a NIAID DAIT Medical Officer is assigned.

c. Monitoring Boards. The AADCRC PD(s)/PI(s) will cooperate with and will abide by the decisions of the NIAID Data and Safety Monitoring Board (DSMB) or any other monitoring body that the NIAID will assign to the study.

2. Investigational New Drug Applications (IND)
It is the responsibility of the PD(s)/PI(s) to contact Regulatory Authorities and obtain guidance as to the need for an IND or IDE (Investigational Device Exemptions) for interventions (whether to be used for therapeutic or mechanistic purposes) that are planned to be employed in any clinical study or trial, if these interventions are not approved for the specific indication (including medical condition, age range, dose range) for which they will be used in the research project. In most cases of clinical trials under the FOA where an IND/IDE is required, either an awardee or the organization supplying the investigational agent or device will serve as the IND/IDE sponsor. The sponsor of an IND/IDE is responsible for the development, assembly, and submission of all required regulatory documents, and will provide NIAID all required information following NIH clinical research guidance. This includes but is not limited to all communications with the FDA (or other regulatory authority) and the IRB. In rare cases, NIAID retains the right to become the IND/IDE sponsor. If NIAID is the IND/IDE sponsor, then the NIAID is responsible for the development, assembly, and submission of all required regulatory documents, unless this responsibility is otherwise delegated by the NIAID. If NIAID is the sponsor, the PD(s)/PI(s) is responsible for providing all information to NIAID that is needed for compliance with FDA regulations.

3. Clinical Trial Monitoring
In all AADCRC clinical trials and studies, the PD(s)/PI(s) of the Center has the financial and organizational responsibilities for data and safety site monitoring and medical monitoring. These include monitoring compliance with good clinical research practices, regulatory compliance, accurate protocol implementation, internal quality assurance, and test agent accountability at the clinical research sites.  Additional responsibilities to regulatory authorities that arise as a result of the PD(s)/PI(s) or another scientist of the Center being the IND/IDE sponsor of clinical trials supported by this FOA also belong to the PD(s)/PI(s) of the Center.

For all clinical trials and some clinical studies (to be identified by NIAID post-award), the PI is responsible for ensuring independent monitoring through a clinical monitoring plan and for obtaining NIAID approval of the plan. This plan should include site monitoring by experienced professionals who are independent from the Center PD(s)/PI(s) or the trial or study investigators.  In addition, in all clinical trials and in some clinical studies (to be identified by NIAID post-award), the Center PD(s)/PI(s) is responsible for including an Independent Safety Monitor (ISM) in the clinical monitoring plan. The ISM is a licensed physician with clinical research experience, administratively independent from the PD(s)/PI(s) team. The ISM will conduct safety monitoring by reviewing all serious adverse events, protocol deviations, individual and study stopping rules.  In some studies (to be identified by NIAID post-award), the ISM may also be required to conduct pre-study initiation protocol and consent document review, as well as periodic post-initiation safety and data review. 

4. Safety Reports
If the PD(s)/PI(s) is the IND/IDE sponsor in any clinical trial supported by this FOA she/he is responsible for submitting complete safety reports to the FDA, per FDA regulations.  The PD(s)/PI(s) will submit these reports to NIAID for review prior to submission to the FDA.  For all clinical trials that are under a DSMB (or any other monitoring body) review, even if no IND/IDE is involved, the PD(s)/PI(s) has the responsibility for preparing and presenting annual safety reports.

Access to Data
The PD(s)/PI(s) is responsible for making data available for external checking against the original source documentation as required by federal regulations.

Awardees will retain custody of and have 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. However, awardees must be committed to making the biological samples, diagnostic products, and other research tools, methods, data, and materials that they develop under AADCRC awards available to the AADCRC and the research community, per policies established by the AADCRC steering committee.  Informed consent/assent forms utilized in AADCRC-supported clinical trials or studies should reflect this commitment.

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

  • NIAID may assign a Project Scientist to an AADCRC Center. Project Scientists may provide guidance and support in the design of research activities, may serve as a resource for protocol design and development, may provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities, may advise in the selection of sources or resources, and may advise in management and technical performance.  In AADCRC Centers that include clinical trials and in, some cases, clinical studies, the NIAID-assigned Project Scientist will be a Medical Officer.
  • In addition, two NIAID Project Scientists will be non-voting members of the Steering Committee and participate in all Steering Committee activities, including conference calls, subcommittees and special committees. However, the role of the NIAID Project Scientists will be to facilitate and not direct activities. It is anticipated that decisions in all activities will be reached by consensus and that the NIAID Project Scientists will participate in this process.

Clinical Research Oversight
1. Protocol Development, Review and Approval
NIAID staff will participate with AADCRC PD(s)/PI(s) in the development, review, and approval (as mentioned above) of all clinical trial and some non-trial, clinical study protocols for projects supported by this FOA. All clinical research protocols will be reviewed by NIAID and, depending on their level of complexity and risk, will be further reviewed by the NIAID DAIT Clinical Research Committee and by the NIAID DAIT Data and Safety Monitoring Board (DSMB) or another monitoring body. Prior to initiation, all clinical research protocols must be approved by an assigned NIAID Medical Officer.

2. IND/IDE
For clinical trials under this FOA where NIAID is not the IND/IDE sponsor, NIAID will provide guidance on the development and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the FDA or other applicable health authorities. NIAID retains the right to have NIAID serve as the IND/IDE sponsor.

3. Clinical Trial Monitoring
If NIAID holds the IND/IDE for a clinical trial supported by this FOA, NIAID will be responsible for monitoring compliance with good clinical research practices, regulatory compliance, accurate protocol implementation, internal quality assurance, and test agent accountability at the clinical research sites. In studies where NIAID does not serve as the IND/IDE sponsor, NIAID will review and approve the clinical monitoring plan, review the recruitment status of the trial on an ongoing basis, review the results of clinical trials, and provide oversight of data and safety monitoring.

4. Safety Reports
NIAID will convene an independent NIAID Data and Safety Monitoring Board (DSMB) or another monitoring body to review and monitor any protocols deemed to possess more than minimal risks.

If NIAID holds the IND/IDE for clinical trials supported by this FOA, NIAID will be responsible for reporting safety information in accordance with FDA requirements. An NIAID Medical Officer or NIAID designated contractor will monitor the clinical trials and serve as the Medical Monitor.

5. Study Termination
NIAID reserves the right to terminate or curtail a clinical study for any of the following reasons:

(1)  risk to subject safety;

(2)  the scientific question is no longer relevant or the objectives will not be met;

(3)  failure to comply with Good Clinical Practices, federal regulations, or Terms and Conditions of Award;

(4)  occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity;

(5)  risks that cannot be adequately quantified;

(6)  failure to remedy deficiencies identified through site monitoring;

(7)  substandard data;

(8)  inadequate progress in fulfilling the research agenda;

(9)  slow accrual; or

(10) reaching a major study endpoint substantially before schedule with persuasive statistical significance.

6. Access to Data
The NIAID Project Scientists or designee will have access to all data generated under this cooperative agreement, and may review the data as recorded on the case report forms or in a database. Data must be available for external checking against the original source documentation. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.

The program official will negotiate data deposition timelines with each awardees post award, and facilitate data deposition to either ImmPort (https://immport.niaid.nih.gov) or to another NIAID resource.

7. Performance Monitoring
The NIH Project Scientists will review the performance of each participating AADCRC through consideration of annual reports, site visits, and compliance with NIH procedures.

Scientific and Programmatic Oversight
An NIAID program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This stewardship includes monitoring program progress, approving changes and concurring in proceeding into study implementation stage. Release of each yearly funding increment for AADCRC U19s will be based on a review of progress.

Areas of Joint Responsibility include:

Steering Committee
A Steering Committee will serve as the governing board for AADCRC awardees. All participants in the AADCRC program are bound by the policies and procedures developed by the Steering Committee; adoption of such policies and procedures requires a majority vote. Awardees under this FOA will be required to accept and implement policies approved by the Steering Committee.

Membership in the Steering Committee will include the PD(s)/PI(s) of each AADCRC U19 award, a designated representative in the case of Multiple PD(s)/PI(s) award, and two NIH Project Scientists. The chair will be chosen by a majority vote of the Steering Committee, with terms determined by the committee. Each AADCRC center will have one vote. The two NIH Project Scientists will be non-voting members and will not serve as the Chair of the Steering Committee.

For multi-PD(s)/PI(s) applications, only one PD/PI per AADCRC U19 will be allowed to serve on the Steering Committee at a time. For these multi-PD/PI U19s, the representing PD/PI should be declared by notification sent to the NIAID Steering Committee Project Scientist and the Steering Committee Chair.  Such notification should be signed by all PD(s)/PI(s) of the U19 in question.  The same process will be followed if a change in the PD/PI representing the multi-PD/PI U19 at the Steering Committee is to be made. 

Steering Committee responsibilities will include:

  • Evaluating, reviewing, and recommending new collaborations and resource allocations among AADCRC members;
  • Establishing goals and priorities for the use of the Infrastructure and Opportunity Funds; developing policies, procedures, and instructions for the solicitation and submission of proposals to use these funds, including establishing a definition of young investigators eligible to apply for the funds; and establishing criteria and the process for the assessment of the technical merit, feasibility and appropriateness of all such proposals;
  • Coordinating research resource sharing among AADCRC, including reagents and samples.

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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

A final progress report, 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-435-0714

Scientific/Research Contact(s)

Gang Dong, MD, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3508
Email: gdong@mail.nih.gov

Peer Review Contact(s)

Louis A. Rosenthal, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5070
Email: rosenthalla@niaid.nih.gov

Financial/Grants Management Contact(s)

Jordan A. Kindbom
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2983
Email: jordan.kindbom@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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