Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Purpose

This notice of funding opportunity (NOFO) 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 translational 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 airway 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 pharmacologic or biologic interventions that offer either only symptomatic relief or have nonspecific anti-inflammatory activities and do not alter the natural history of the disease. Allergen immunotherapy for aeroallergens and perhaps food allergens or early dietary introduction of food allergens offer promise in disease modification and prevention, but require further study.

• Asthma affects approximately 8% of the U.S. population, including 5-6 million children, and is one of the major causes of missed school days and hospitalization in children and adolescents. Severe asthma affects 5-10% of all patients with asthma but is responsible for a much higher social and economic burden when compared with mild and moderate disease. Despite advances in understanding asthma endotypes, large gaps remain in determining the immunologic pathways that lead to the inflammatory presentations of severe disease.
• Allergic rhinitis is estimated to affect approximately 60 million people in the United States. Large numbers of patients with these conditions do not achieve adequate relief with available medications, resulting in substantial social and economic burdens.
• Non-allergic rhinitis affects close to 30 million people and presumably includes a number of distinct syndromes, but no systematic research has been conducted to determine phenotypes and endotypes, a necessary step towards rational development of novel therapeutic approaches.
• Chronic rhinosinusitis with or without nasal polyps, which is estimated to affect up to 12% of the U.S. population and results in roughly 15 million physician visits and 200,000 sinus surgical procedures each year, manifests as persistent inflammation of the nasal and sinus mucosa, is heterogeneous, and remains difficult to manage despite recent advancements with anti-type 2 cytokine monoclonal antibodies. Research to better elucidate endotypes and define the early events in the development of the disease is needed.
• Atopic dermatitis affects approximately 20% of infants, 10-12% of children under age 18 and up to 7-8% of adults in the United States. Despite the known scientific associations between atopic dermatitis and allergic disease, the role of allergy in atopic dermatitis and the etiologic and pathophysiologic interactions between atopic dermatitis and food or respiratory allergy are incompletely understood.
• Food allergy affects approximately 8% of children and, as recently suggested, 10% of adults. Food allergy is the most frequent cause of emergency department visits for anaphylaxis. The mechanisms of food allergy development are not fully understood and require further investigation. Recent advancements in the prevention of food allergy with early allergen consumption and in the management with anti-IgE and allergen immunotherapy are beneficial, but much remains to be learned regarding the mode of action of these approaches, understanding non- or poor responsiveness to treatment, and developing predictive biomarkers to optimize management. Better biomarkers also are needed for food allergy diagnosis to reduce the need for oral food challenges in research or in the clinic.  
• Allergic drug reactions are defined for the purpose of this NOFO as reactions that have an immunologic component. These reactions result in excess morbidity, particularly in patients who are in need of the drug in question and have underlying serious conditions. The 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 influence the expression of many of these diseases later in life. These exposures involve not only allergens, but other immunologically active agents that may include bacteria, viruses, fungi, and various environmental substances. Some of these exposures may be protective against allergic disease, but much remains to be learned as to the mechanisms of protection. Interactions of early exposure to these factors plus an individual's genetic makeup shape the development of the immune system and together determine the risk for allergic disease. Recent insights raise the possibility that epigenetic modifications also play a role in controlling the function of the immune system and that these modifications also are influenced by environmental exposures.

Allergen-specific immunotherapy trials with food and aeroallergens have demonstrated reduced responsiveness to the allergens in question, a protective effect that also can be sustained after discontinuation of treatment. The Learning Early About Peanut Allergy (LEAP) trial has shown substantial reduction in the development of peanut allergy with early introduction and maintained exposure of peanut-containing food in high-risk infants. This effect lasts at least into early adolescence. Earlier studies have suggested that allergen immunotherapy in children with allergic rhinitis may 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 and usability. In addition, new forms of immunotherapy are under development and require testing.

The NIAID AADCRC program, established over 5 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. This program supports multi-project collaborative applications designed to leverage expertise provided by Centers located throughout the United States.

Objectives and Scope

The objective of this NOFO is to support multidisciplinary research on the following conditions of interest: 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.

NIAID programmatic priorities for this NOFO are to evaluate:

• The role of innate and adaptive immune functions in the development and pathogenesis of asthma and allergic diseases with a focus on severe asthma, chronic rhinosinusitis, allergic rhinitis, food allergy, atopic dermatitis, and drug allergy;
• The impact of the microbiome on immune responses as they pertain to the development, prevention, and management of asthma, allergic rhinitis, chronic rhinosinusitis, food allergy, and atopic dermatitis;
• The impact of pollution, and/or acute or chronic climate events on immune responses as they pertain to the development, prevention and management of asthma, allergic rhinitis, and chronic rhinosinusitis;
• Epithelial biology/immunobiology and/or neuroimmune interactions and how they relate to development, persistence, and severity of allergic diseases including asthma, allergic rhinitis, chronic rhinosinusitis, food allergy, and atopic dermatitis;
• The interaction between infections and allergic diseases, and the role of immune responses to infections in the development and exacerbations of asthma, allergic rhinitis, chronic rhinosinusitis, and atopic dermatitis;
• The mechanisms of allergen immunotherapy-induced clinical desensitization and tolerance for the treatment of asthma, allergic rhinitis, and food allergy and improving the efficacy, safety and ease of use of this therapeutic modality;
• The genetic variations and epigenetic alterations affecting host immune responses to aeroallergens, food allergens and drug allergens and patient responses to therapeutic interventions in asthma, allergic rhinitis, chronic rhinosinusitis, food allergy, atopic dermatitis and drug allergy;
• Clinical, immunologic and physiologic phenotypes and endotypes of understudied diseases including non-Type 2 asthma, drug or vaccine allergy, chronic rhinosinusitis, non-allergic rhinitis syndromes, eosinophilic gastrointestinal disorders, food protein-induced enterocolitis syndrome (FPIES), alpha-gal syndrome, and chronic spontaneous urticaria that provide mechanistic insights for disease etiology or management.

In order to ensure the focus of the applications is on human disease, the majority of the proposed research within each application must be defined as human subjects research (for the HHS definition of human subjects research, please see the NIH Office of Extramural Research Human Subjects) or utilize human material (including primary human cells, biologic samples, and clinical data). Studies using only transformed human cell lines will not satisfy this requirement. Very limited animal research may be included based on the need for experimentation that is not possible in humans or with human materials, and the animal studies must be fully justified and clearly integrated into an overall experimental plan that will translate animal findings to human disease.

Highly integrated and synergistic research Centers are encouraged for the AADCRC program. This includes multi-institutional applications for conditions of interest to this NOFO, especially where research resources are limited (e.g., non-allergic rhinitis or drug allergy). AADCRC Research Centers funded under this NOFO will comprise 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 must be integrated with the other components within the same application.

In order to achieve this NOFO’s objective, it is recommended, but not required, 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 one or more immunologic mechanism(s)/pathway(s) that are hypothesized to be important pathobiologic processes in a condition of interest, as specified in this NOFO, or in allergy, in general. This/these mechanism(s)/pathway(s) may involve a single cellular or 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 such pathways from various perspectives, including clinical studies or pilot single-site clinical trials, genetics, systems biology approaches, in vitro work, or, if necessary, animal models. The proposed research must focus on human research, and utilize human material (including primary human cells, biologic samples, and clinical data). Very limited research using animal models may be proposed in parallel to human subjects research, only if it provides more in-depth hypothesis testing on outcomes that cannot be assessed with human research.

• MODEL B – Clinical Intervention/Observation Focus

The application is centered around one or more single-site pilot 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 NOFO. The pilot 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 pilot clinical trial(s) or observational study(ies) including mechanistic studies, systems biology approaches (including genomics, epigenomics, metabolomics, etc.), microbiome studies, or genetics. If proposed, pilot trials or studies must be single-site studies. 

The majority of the proposed research must meet the HHS 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 NOFO or clinical specimens from such individuals. Studies using human specimens obtained from relevant ongoing or completed clinical studies or clinical trials may also be proposed.

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 (https://grants.nih.gov/grants/glossary.htm#ClinicalTrial). For the purposes of this NOFO, a research study that meets this definition and involves interventions aimed at understanding mechanisms of disease (e.g. allergen challenges, experimental exposure of humans to an inflammatory mediator or to a rhinovirus), or aims at developing or evaluating clinical laboratory tests (imaging or molecular diagnostic tests) might be considered a clinical trial.

Clinical trials proposed for this NOFO should be limited in scope, with well-defined timelines supporting feasibility during the grant period. Clinical trials proposed should be single site pilot studies offering insight into mechanisms of disease or therapeutic response. Only new clinical trials can be proposed for this NOFO. A new trial is defined as one that has not previously recruited any subjects and will not be recruiting any subjects prior to award. If the proposed pilot clinical trials are intended to test a novel hypothesis, the pilot clinical trial must be proposed as a project and applicants must follow the instructions for the pilot clinical trial below. If two trials are highly related and share most aspects of study design, they can be presented within the same project.

Applicants are advised that, in the event their application is selected for NIAID funding, any proposed clinical trials will be reviewed by the Project Scientist(s) that NIAID will assign to the study; the NIAID Division of Allergy, Immunology and Transplantation (DAIT) Clinical Research Committee; and the DAIT Asthma and Allergy Data and Safety Monitoring Board (DSMB). Final clinical protocols will be developed collaboratively.

It is the responsibility of the Program Directors/Principal Investigators (PD(s)/PI(s)) to contact regulatory authorities and obtain guidance as to the need for an Investigational New Drug (IND) or Investigational Device Exemptions (IDE) for interventions (whether to be used for therapeutic or mechanistic purposes) that are planned to be employed in any pilot clinical trial. If an IND is required, it is expected that, in most instances, either the recipient 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 and complying with NIH Grants Policy Statement. This includes, but is not limited to, all communications with the FDA (or other regulatory authority) and the Institutional Review Board (IRB). However, NIAID reserves the right to decide whether it will be the Sponsor of a clinical trial and hold the IND. If NIAID is the IND/IDE Sponsor, it will be responsible for the development, assembly, and submission of all required regulatory documents, unless this responsibility is otherwise delegated by 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.

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

• Research on autoimmunity and autoimmune diseases
• Research on primary immune deficiency diseases
• Research with a primary focus on chronic respiratory diseases other than asthma, rhinitis or rhinosinusitis
• Demonstration and Education Research Projects
• Multi-center clinical trials
• Phase III clinical trials
• Clinical trials at foreign sites; however foreign components conducting mechanistic projects, observational studies, specialized assay(s), etc. will be allowed.
• Continuation of ongoing (active) clinical trials.
• Applications in which the majority of the proposed research does not meet the human subjects research definition or does not utilize human material (including primary human cells, human biologic samples, or clinical data).
• Research involving only healthy volunteers
• Research on HIV or AIDS

AADCRC components

Administrative Core (required): Each application must contain an Administrative Core that is responsible for the overall management, communication, coordination, and supervision of the Center. Duties of the Administrative Core must include a plan of administering the AADCRC Infrastructure and Opportunity Fund (IOF). The Administrative Core Lead will provide leadership and guidance in fulfilling the stated objectives of the Center, and is responsible for generating, within the Administrative Core, an infrastructure that promotes cross-discipline interactions among all of the Cores and Research Projects and provides oversight and governance over fiscal and resource management.

AADCRC IOF: A single IOF of up to $350,000 direct costs per year will be established under this NOFO to support new and pilot research projects led by investigators within the AADCRCs, as well as for the development of resources that the AADCRC Steering Committee may deem necessary. The IOF will support new research opportunities not proposed at the time of the awards. The Steering Committee will establish goals, priorities, and evaluation criteria for the use by the IOF. Any use of the IOF must comply with all applicable HHS/NIH policies. Post-award, PD(s)/PI(s) funded under this NOFO will have an opportunity to compete for IOF funds for new and pilot research projects and resource development projects and will be provided with details regarding IOF management and the application process.

After awards have been made, one AADCRC grant recipient 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.

External Advisory Committee (EAG) (optional): an EAG for each individual Center, comprised of experts in the field, may be established after award at the discretion of the individual Center PD(s)/PI(s). The EAG will review progress of the Center.

Data Stewardship Core (required): A Data Stewardship Core must be included and will provide central data management and analysis services (e.g., database establishment, data collection and cleaning, data storage) to the Cores and Research Projects. This Core is responsible for carrying out the Data Management and Sharing Plan, as well as information security services to all researchers within the Center. The Data Stewardship Core will be responsible for ensuring the timely submission of data, meta-data, and related data analyses to the ImmPort database or other public databases, as appropriate. In addition, this Core may provide bioinformatics expertise and data integration and analysis support within the Center. The Core also may include study design and statistical support/services for the researchers within the Center. The Data Stewardship Core must support all Research Projects and Scientific and/or Clinical Cores, as needed, in the Center.

Clinical Core (optional): A single Clinical Core may be included, as necessary, to ensure the success of the supported Research Projects and the overall goal(s) of the Center. If proposed, the Clinical Core must support at least two Research Projects in the Center. A Clinical Core may be responsible for the recruitment, organizational, and regulatory aspects of a pilot clinical trial or any proposed observational study.

Scientific Core(s) (optional): Up to two Scientific Cores may be included, as necessary, to ensure the success of the supported Research Projects and the overall goal(s) of the Center. Examples of possible Scientific Cores include, but are not limited to, a Genetics/Genomics Core, a Flow Cytometry Core, and/or other Research Laboratory Cores. Scientific Core activities must not overlap with each other, or with the activities of a Research Project or other proposed Core(s). Scientific Cores must support 2 or more Research Projects in the Center.

Research Projects (required): Each application must contain at least two Research Projects organized around a common theme or hypothesis. Research proposed in the Research Projects should meet the HHS definition of Human Subjects research (see the NIH Office of Extramural Research Human Subjects) or utilize human material. A pilot clinical trial or an observational study may be included within a Clinical Core or a Research Project, depending on the intention of the trial or study. If a pilot clinical trial or observational study is not designed to test a hypothesis, but instead is only meant to collect and provide samples for at least two Research Projects, then the clinical trial or study should be included as a Clinical Core. If pilot clinical trials or observational studies are intended to test a novel therapeutic approach or a novel mechanistic hypothesis they must be proposed under a Research Project. Healthy volunteers may be included in proposed clinical studies, but only as controls. Single site pilot clinical trials, if proposed, are limited to Phase I or Phase II.

Resources Provided by NIAID: For all clinical trials that will be conducted, NIAID will provide a Data and Safety Monitoring Board (DSMB).

Steering Committee: PD(s)/PI(s) funded under this program will become members of the AADCRC Steering Committee after award. The Steering Committee serves as the main governing body for the cooperative group. The Steering Committee will facilitate collaborations and establish policies to promote resource sharings among centers and outside collaborators, establish goals, guidelines, evaluation criteria and funding plans for the yearly IOF competition, set agendas for the annual AADRC scientific meetings, and propose AADCRC-centered sessions for national and international scientific meetings.

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

Note:  Please refer to the  Frequently Asked Questions (FAQ) page for additional guidance.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• 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

Institutions with active AADCRC awards funded under RFA-AI-21-079 are not eligible to apply to this NOFO. NIAID will make only one AADCRC award per eligible institution.

Non-domestic (non-U.S.) Entities (Foreign Organization) 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. 

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active 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.

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.

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 How to Apply - Application Guide.

Research Projects are limited to a single Research Project Lead per project; Cores are limited to a single Core Lead. An investigator can serve as a PD/PI on only one active AADCRC award or new application. This includes all PD(s)/PI(s) of a multiple-PD/PI application.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique entity identifier (UEI) number of NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Poonam Tewary, PhD
Telephone: 240-532-9777
Email: poonam.tewary@nih.gov 
 

Page Limitations

All page limitations described in the How to Apply- 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 How to Apply- 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
• Data Stewardship Core: required: 1, the Data Stewardship Core must support all Research Projects, and will support other Scientific/Clinical Core(s), as needed
• Clinical Core: optional, maximum 1, the Clinical Core must support at least two Research Projects
• Scientific Core: optional, maximum 2, each Scientific Core must support at least two Research Projects
• Research Projects: required, minimum 2, no maximum

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - 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 Locations (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 and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) 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 Center. Concisely describe the hypothesis or hypotheses to be tested. 

Research Strategy: Describe the focus of the research Center. This narrative section should summarize 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 Center 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 Research Project and Core should be cited briefly as to its place in the overall scheme. To help achieve the NOFO’s objective, it is recommended, but not required, to draft the applications along the lines of either of the two models: the Pathway Focus (Model A) or Clinical Intervention/Observation Focus (Model B) as described under Part 2, Section I.

To highlight Center synergy, describe how the individual components will be coordinated and work together to address the overall goals and aims of the Center. 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 Center. Center synergy may also be addressed in other sections of the application, as appropriate. Discuss the role of all Research Projects and Cores in the Overall Research Strategy of the application. Describe how the integration of the individual Research Projects into a single Center benefits the objectives more than pursuing each project independently. For renewal applications, describe the impact that the Center’s prior accomplishments have had on the field of asthma and/or allergic disease.

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/or Core.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• Recipients are encouraged to deposit data into the ImmPort database.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

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

All instructions in the How to Apply- 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.

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) (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)

• 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.
• For institutions/organizations proposing a single PD/PI, the PD/PI will serve as the Administrative Core Lead. For institutions/organizations proposing multiple PD(s)/PI(s), the Contact PD/PI must serve as the Administrative Core Lead.   

Budget (Administrative Core)

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

In the budget, include funding for the overall administrative efforts, administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses.

Infrastructure and Opportunity Fund (IOF): Propose funds for the IOF within the Administrative Core component; the IOF budget is not expected to exceed $350K in direct costs. This will be awarded to one recipient organization that will be selected by NIAID post-award to manage the fund. Include IOF costs as a single line item in the Other Direct Costs Category of the Administrative Core Budget. A part of the IOF budget, direct costs proposed for an IOF administrator may be requested in the Personnel category for a maximum of 0.5 person months and must comply with NIH grants policy. F&A Costs will be applied in accordance with NIH grants policy.

Include travel funds for the PD(s)/PI(s) and subproject PD(s)/PI(s) to attend an annual AADCRC Scientific and Steering Committee meeting. The two-day meeting will be held each year in or near Rockville, 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. Describe the work to be completed to address issues of Center coordination, communication, management, and administering the IOF. Testing of scientific hypotheses should not be proposed within a Core.

Research Strategy: A fully developed and well-described Administrative Core plan is required.

Describe and justify the operational plan and organizational structure of the proposed multi-component application. Include plans on how the PD(s)/PI(s) will interact and coordinate with Project/Core Leaders to identify and resolve problems and establish a strong collaborative environment for the Center. 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, group meetings, and teleconferences will be facilitated; how conflict resolution will be attained; and how research related travel and training will be managed. Describe how the Core’s administrative, management, and leadership capabilities provide for: internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements, fair communication and cooperation among program leaders and/or program investigators, and development of scientific meetings, as applicable. Present a leadership succession plan.

Provide a plan to administer the AADCRC Infrastructure and Opportunity Fund (IOF), including fund disbursement, administration, and reports. Within the plan, address the following: 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; and establishing procedures, formats, and timelines for reporting on the status of IOF projects and expenditures to the NIAID and the AADCRC Steering Committee.

External Advisory Group (optional): If an EAG is proposed for an individual Center, then describe the expertise and responsibilities of the potential members. Discuss how the individual Center Research Projects will be supported by the EAG. For a new application, do not contact or name potential members in the application. For a renewal application with an EAG already established, provide the names only of current EAG members in the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply - Application Guide; any instructions provided here are in addition to those in the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

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

Data Stewardship Core

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

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Data Stewardship 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 (Data Stewardship Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Stewardship 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.

Facilities & Other Resources: Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.

Project/Performance Site Location(s) (Data Stewardship 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 (Data Stewardship 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.

Budget (Data Stewardship Core)

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

Request funds to support central data management (database establishment, data management and cleaning, data storage, database security) for the entire awarded U19 Cooperative Agreement to all researchers within the applicant group.

In case the statistical design and analysis of data for at least two Research Projects is to be conducted by this Core, request funds to support appropriate biostatistical personnel and equipment use effort.

Request funds to support the required timely submission of data, meta-data and data analyses to the ImmPort database or other public databases as appropriate.

The percentage of total funds that will be required to support each component Research Project or Core that will utilize the Data Stewardship Core should also be presented. This information should be included in the Core’s budget justification for Year 1.

For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). 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 (Data Stewardship 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 Center’s goals and how the Core relates to all the activities of individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.

Research Strategy:

Describe and justify the overall function of the required Data Stewardship Core. Describe how the services of this Core (including procedures, techniques and quality control) will support all proposed Research Projects and Scientific and/or Clinical Cores, and advance the outcomes from the proposed research Center.

Describe how the Data Stewardship Core will facilitate the harmonization of data collection and analysis services across all Research Projects and Scientific/Clinical Cores, as needed. Discuss how the Core will support data management by providing appropriate team expertise. Describe the plans for development of harmonized protocols, including selection and use of common data elements, if applicable. Explain the processes, procedures, methods and plans to provide bioinformatics infrastructure support for Center-wide database establishment, data cleaning and tracking, information management, curation, data monitoring, data storage and quality control. Outline how the Core will promote the exchange of information among all recipients of this NOFO.

If the Data Stewardship Core will support the statistical design and data analyses for Research Projects and/or a Clinical or Scientific Core, provide general descriptions of statistical approaches to be used. However, specific statistical analyses addressing scientific hypotheses should be described within each of the Research Projects or within the Clinical or Scientific Core, whichever is applicable.

Note that information requested here for this Core should not duplicate the information provided in the Data Management and Sharing Plan. Place information regarding plans to comply with the NIH Data Management and Sharing Policy in the Data Management and Sharing Plan attachment in the “Other Plan(s)” section of the Overall component.

Note: Specific details for clinical trials and studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.   

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Data Stewardship Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

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

Clinical Core

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

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clinical 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 (Clinical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical 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.

Facilities & Other Resources: Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.

Project/Performance Site Location(s) (Clinical 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 (Clinical 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.
• Within the biosketches, highlight the expertise of the Clinical Core Lead 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 (if applicable), recruitment and retention of study participants, medical monitoring, and safety oversight and reporting.

Budget (Clinical Core)

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

For Year 1, outline the percentage of total funds that will be required to support each component Research Project that will utilize the Clinical Core

If a clinical trial is proposed, include costs for a medical monitor.

For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, do not 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 (Clinical Core)

Specific Aims: List in priority order the broad, long-range activities and services of the proposed Clinical Core. In addition, state the Core’s relationship to the Center’s goals and how the Core relates to two or more individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.

Research Strategy:    

Describe how the Clinical Core will support at least one of two purposes: 1) recruit and characterize human subjects and collect appropriate biosamples in support of at least two Research Project(s), and/or 2) conduct one or more single-site pilot clinical trials or clinical studies in support of at least two Research Projects.

• Describe how the proposed Clinical Core activities will contribute to meeting the Center’s goals and objectives and explain why the Core resources are not otherwise available.
• Describe how resource utilization will be allocated and/or prioritized, if applicable, to support the Center. Indicate the specific projects to be supported by the Clinical Core.
• Describe the services provided by the Core (including procedures, techniques, and quality control).

If the Clinical Core proposes single site pilot clinical trials and/or studies designed only to collect and provide samples for two or more Research Projects, describe the following aspects of the proposed trial(s)/study(ies):

• Discuss the rationale and process for the selection, recruitment and retention of the participant population, choice of intervention (if applicable), choice of study sites, duration, plans for trial management and schedule of events.
• Discuss the trial/study's feasibility, difficulties that may be encountered, and offer alternative approaches to be implemented, if needed, include general concepts for sample size determinations and statistical methodologies, but, particularly for pilot clinical trials, provide study-specific details in the PHS Human Subjects and Clinical Trial Information Forms.

Note: If a clinical trial/study is included in a Research Project (and not as a Clinical Core), then the above information should appear as part of that Research Project.

Note: Specific details for trials and studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.   

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Clinical Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

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

Scientific Core

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

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Scientific 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 (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific 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.

Facilities & Other Resources: Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.

Project/Performance Site Location(s) (Scientific 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 (Scientific 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.

Budget (Scientific Core)

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

For Year 1, outline the percentage of total funds that will be required to support each component Research Project that will utilize the Scientific Core.

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 (Scientific Core)

Specific Aims:

• Discuss the Core’s relationship to the Center’s goals and how the Core relates to two or more individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.

Research Strategy:     

• Describe how the proposed Scientific Core activities (including procedures, techniques and quality control) will contribute to meeting the Center’s goals and objectives and explain why the Core resources are not otherwise available.
• Describe how resource utilization will be allocated and/or prioritized, if applicable, to support the Center.

Indicate the specific Research Projects to be supported by the Scientific Core. Describe the interactions of the Core with each of the Research Projects.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.   

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Scientific Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

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

Research Project

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

All instructions in the How to Apply- 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.
• Within the biosketches, highlight the experience and expertise of the Research Project Lead and key personnel in regulatory activities, including IND/IDE submissions, safety oversight and reporting.

Budget (Research Project)

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

In single PD/PI applications, the PD/PI must also lead at least one Research Project and is required to commit an overall minimum of 2 person months in AADCRC activities. In multi-PD/PI applications, every PD/PI must lead a Research Project or Core, with at least one of the PD(s)/PI(s) leading a Research Project and committing an overall minimum of 2 person months to AADCRC activities.

Include costs to support statistical design/support, data collection and analysis if those are not included in one of the Cores.

If the Research Project involves a pilot clinical trial or a clinical observational study:

• Include costs for clinical site monitoring, medical monitoring, project management, and quality assurance of the proposed pilot clinical trials or observational clinical studies in the application budget. Alternatively, these costs can be incorporated into the budget of a Clinical Core, provided that specific cross-references are made to clarify how these necessary functions will be supported.

Note: For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, do not 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 objectives and goals of the proposed project.
• Concisely describe the hypothesis or hypotheses to be tested. In addition, state the individual Research Project's relationship to the Center’s goals and how it relates to other projects or Cores.

Research Strategy:    

• Describe how the proposed research will contribute to meeting the Center’s goals and objectives and indicate the project's relevance to the primary theme of the application.
• Explain the rationale for selecting the methods to accomplish the specific aims of the Research Project.
• Provide a detailed timeline for the study supporting completion within the funding period.

Clinical Trials

The Approach section of a pilot clinical trial project should address the following aspects of the proposed trial(s):

• Discuss the rationale for the proposed approach for the problems being studied.
• Describe the design of the proposed trial, include rationale for the selection of the participant population, choice of intervention (if applicable), duration, and schedule of events.
• Discuss each trial’s feasibility.
• Include a plan for the management of the pilot clinical trial that offers description of personnel involved in 1) conducting the trial, and 2) data entry and interactions with the activities of the Data Stewardship Core.
• Include general concepts for sample size determinations and statistical methodologies, but provide trial-specific details in the PHS Human Subjects and Clinical Trial Information Forms.

Note: Specific details for each trial will be captured using the PHS Human Subjects and Clinical Trials Information Forms. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.

Clinical studies

For applications proposing one or more clinical studies (observational studies with no interventions and involving only minimal risk procedures or cross-sectional studies), the Approach section of the clinical study project should address the following aspects of the study:

• Describe the design of the proposed study, include rationale for the selection of the participant population, choice of outcomes, duration, and schedule of events. 
• Discuss each study's feasibility. Include a plan for the management of the clinical study that offers description of personnel involved in conducting the study, personnel involved in data entry, and the personnel involved in statistical analysis. Describe the interactions between these teams and the Data Stewardship Core.
• Include general concepts for sample size determinations and statistical methodologies, but provide study-specific details in the PHS Human Subjects Information Forms.
• Describe the timeline for protocol development, the plan for study implementation, the plan for evaluation of proposed study site(s), and plans for management and analysis of study data.
• For observational or cross-sectional clinical studies, describe the data analyses and statistical approach for the proposed study design and methods used to assign participants.

Note: Specific details for each study will be captured using the PHS Human Subjects Information Form. Do not duplicate information requested under the PHS Human Subjects Information Forms.

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 analysis 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)

Non-clinical research

• Describe the research design conceptual procedures and analyses to be used to accomplish the specific aims of the project.
• In the rare instances where animal models are proposed, justify the models and describe how the findings could be translated into human research and how they associate with the proposed clinical project(s).
• Provide a tentative timetable for the project.
• If animal studies are included, describe the relevance of the proposed animal model(s) to human asthma and/or allergic diseases. Describe the scientific potential for findings in animals to translate to human disease and appropriately justify the use of animal models if similar data could be obtained from human studies.

Letters of Support: For Projects obtaining human samples from non-AADCRC-supported clinical studies or trials, include 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 How to Apply- Application Guide.   

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed with the following additional instructions:

Section 2 - Study Population Characteristics

2.5 - Recruitment and Retention Plan

Describe actions to be taken to address problems with recruitment of study participants.

Section 4 - Protocol Synopsis

4.1 Study Design

4.1.a Detailed Description

For multi-visit studies, provide a description of the study design including the procedures and activities that can occur at each visit (schedule of events).

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-related Attachments

Describe the plan to obtain required investigational agent(s).

IND applications required by the FDA for any investigational agents should be obtained by applicants prior to submission of applications. Provide the IND documents with other clinical trial related attachments.

Delayed Onset Study

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - 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 the National Institute of Allergy and Infectious Diseases, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

    In addition, for applications involving clinical trials:

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

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).

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

Significance

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

Specific to this NOFO:

How well do the coordination and synergy of the individual Research Projects and Cores contribute towards the achievement of the central objectives of the entire project? To what degree does the integration of the individual Research Projects and Cores benefit objectives more than pursuing each project independently?

In addition, for applications involving clinical trials

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

Investigator(s)

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

In addition, for applications involving clinical trials

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

Innovation

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

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

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

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, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

In addition, for applications involving clinical trials

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

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

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

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

Overall Impact – Research Projects

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for each 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 - 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? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

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

Investigator(s)

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

Specific to this NOFO:

If applicable, to what extent do the Research Project Lead and key personnel have the experience and expertise with regulatory activities, including IND/IDE submissions and safety oversight and reporting?

In addition, for applications involving clinical trials

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

Innovation

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

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

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

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, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

For proposed observational or cross-sectional clinical studies, how appropriate is the timeline for protocol development, the plan for study implementation, the plan for evaluation of proposed study site(s), safety monitoring plans, and plans for management and analysis of study data? For proposed observational or cross-sectional clinical studies, how appropriate are the planned data analyses and statistical approaches?

If animal studies are included, how relevant is/are the proposed animal model(s) to human asthma and/or allergic diseases? How strong is the scientific potential for findings in animals to translate to human disease?  To what degree could similar data have been obtained from human study participants instead of animal models?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

In addition, for applications involving clinical trials

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

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

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

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

Overall Impact – Cores

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

Administrative Core

To what extent does the application describe and justify the proposed Administrative Core operational plan and organizational structure? How well do the Core’s administrative, management, and leadership capabilities provide for: internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements, fair, effective communication and cooperation among program leaders and/or program investigators, and a plan for resolution of disputes, development of scientific meetings and allocation of funds, as applicable? How appropriate is the Administrative Core’s plan to administer the AADCRC Infrastructure and Opportunity Fund (IOF)?

Data Stewardship, Clinical and Scientific Core(s)

How adequately is the Core justified? How well will the Core support at least two Research Projects (or all Research Projects for the Data Stewardship Core)?

How adequate and appropriate are the personnel, facilities or services provided by the Core (including procedures, techniques, and quality control)? How effectively will the services be used?

For the Data Stewardship Core, how well will the Core promote the exchange of information among all recipients of this NOFO?

If a Clinical Core is proposed, how appropriate is the Clinical Core Lead’s 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 (if applicable), recruitment and retention of study participants, medical monitoring, and safety oversight and reporting?  How sound and feasible are the selection of the study population, proposed study site(s), study design, plans for recruitment and retention of study participants and plans for trial management?   

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.

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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 - 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases, in accordance with NIH peer review policies and practices, 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 will receive a written critique.

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.

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

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

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

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

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

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

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Determining and coordinating the scientific and administrative activities of the approved projects;
• Setting project goals and timelines;
• Serving on the AADCRC Steering Committee and participating in all Steering Committee activities;
• Accepting and implementing common guidelines approved by the Steering Committee;
• For clinical trials and other human subject research, implementing current Good Clinical Practice guidelines and complying with the NIAID Clinical Terms of Award;
• For clinical trials in which the PD(s)/PI(s) is the IND/IDE Sponsor, having responsibilty for the development, assembly, and submission of all required regulatory documents, providing NIAID all required information in accordance to NIH clinical research guidance. This includes, but is not limited to, all communications with the FDA (or other regulatory authority) and the Institutional Review Board (IRB). If NIAID is the IND/IDE Sponsor, providing access to all necessary data and documentation to NIAID to fulfill its role.
• Sharing reagents and resources with other investigators funded under this NOFO as appropriate, including any scientists added via IOF support;
• Making data available for external checking against the original source documentation;
• Recipients 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.

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

• NIAID may assign one or more Project Scientist(s) to the AADCRC program. The Project Scientist(s) will:
  • Provide guidance and support in the design of research activities;
  • Provide guidance and support in the execution of studies;
  • Contribute to the analysis and publication of data;
  • Advise in the selection of sources or resources;
  • 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;
  • Assist in planning of the meetings and teleconferences of the Steering Committee and subcommittees, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies.
  • All NIAID staff will be non-voting members of the Steering Committee.

Clinical Research Oversight

• Protocol Development, Review and Approval: The NIAID Project Scientist will participate in the development, review and approval of all clinical research protocols supported by this NOFO.
• In some cases, the NIAID-assigned Project Scientist will be a physician who may also assume the role of Medical Monitor of a clinical study or trial.
• IND/IDE: NIAID retains the right to have NIAID serve as the IND/IDE sponsor for trials involving the use of investigational products.
• Monitoring Boards and Safety Reporting: NIAID Project Scientists will facilitate and provide oversight of the review and reporting of data to DAIT monitoring committees and Data Safety and Monitoring Boards.
• Study Termination: NIAID reserves the right to terminate or curtail a clinical study or clinical trial for any of the following reasons:
  • risk to subject safety;
  • the scientific question is no longer relevant, or the objectives will not be met;
  • failure to comply with Good Clinical Practices, Federal Regulations, or Terms and Conditions of Award;
  • occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity;
  • risks that cannot be adequately quantified;
  • failure to remedy deficiencies identified through site monitoring;
  • substandard data; inadequate progress in fulfilling the research agenda;
  • slow accrual; or
  • reaching a major study endpoint substantially before schedule with persuasive statistical significance.
• Access to Data: The NIAID Project Scientist 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. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Establishing a Steering Committee consisting of the PD(s)/PI(s) of each AADCRC and NIH Project Scientists from NIAID. The NIH Program Officer will be an optional attendee. The Steering Committee’s responsibilities include facilitating collaborative projects, organizing the yearly IOF competition (establishing goals, guidelines and evaluation criteria, evaluating proposed projects, and proposing funding plans), setting the agenda for an annual face-to-face AADCRC scientific meeting, establishing an AADCRC policy to promote resource sharing among AADCRCs and outside collaborators, and proposing AADCRC-centered sessions for national and international scientific meetings.

Each AADCRC Center will have one voting member on the Steering Committee; in the case of multi-PI centers, all PIs/PDs will be Steering Committee members, but must share one vote. NIAID Project Scientists and the NIH Program Officer will be non-voting members of the Steering Committee and participate in all Steering Committee activities. A chair will be elected by the majority of vote among the voting members of the Steering Committee. The Steering Committee will make decisions by majority vote. The Steering Committee will meet by teleconference twice a year and at a face-to-face meeting once a year.

• Collaboratively facilitating the conduct, progress and monitoring of the studies supported by the award.
• Fostering collaborations between AADCRCs.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

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

Poonam Tewary, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-532-9777
Email: poonam.tewary@nih.gov

Lindsey Freeman
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6799
Email: lindsey.freeman@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.

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 2 CFR Part 200.