Asthma and Allergic Diseases Cooperative Research Centers (U19, Clinical Trial Optional)

Asthma and Allergic Diseases Cooperative Research Centers (U19, Clinical Trial Optional) is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). NIAID invites applications from single institutions or consortia of institutions to participate in the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) program.

Expired RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title Asthma and Allergic Diseases Cooperative Research Centers (U19 Clinical Trial Optional) U19 Research Program – Cooperative Agreements March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity Only one application per institution is allowed, as defined in Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Notice of Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to invite applications from single institutions or consortia of institutions to participate in the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) program.

The program will support centers that integrate clinical and 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.

Funding Opportunity Goal(s) To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials.

To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas.

Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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. Required Application Instructions 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. Part 1. Overview Information 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 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. 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.

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: 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 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 Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this NOFO. Application Types Allowed Renewal - Renewals will only be accepted from applicants funded under RFA-AI-20-007 and currently active awards from RFA-AI-16-065 .

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIAID intends to commit $6. 08 million in FY 2026 to fund 4-5 awards, including up to $500,000 for the Infrastructure Opportunity Fund (IOF).

Application budgets are not expected to exceed $900,000 in direct costs per year, excluding the Infrastructure and Opportunities Fund (IOF) budget, and need to reflect the actual needs of the proposed project. The IOF budget is not expected to exceed $350,000 in direct costs per year. The total project period must be five years.

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