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

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Food allergy includes several immune-mediated conditions that have become serious health problems in the United States and other countries. Over the past 3 decades, the prevalence of food allergy in children has increased substantially.

IgE-mediated food allergy is associated with severe and sometimes life-threatening allergic reactions. Among certain cohorts of highly allergic children, accidental exposure results in approximately one reaction per person per year, and 11% of such reactions are severe. It is impossible to predict which individuals are at risk of severe reactions and the gold-standard of diagnosis is to challenge the individual and observe a reaction. There is only one FDA-approved therapy for IgE-mediated food allergy which is limited to peanut and designed only to make children "bite-safe" to accidental exposures; avoidance of food allergens and treatment of food allergy-induced systemic reactions with epinephrine remain the standard of care.

To address the concerns about the increasing incidence of food allergy and paucity of treatment options, NIAID established the Consortium for Food Allergy Research (CoFAR) in 2005. During three consecutive funding periods, CoFAR has conducted clinical trials and observational studies testing various forms of food allergen immunotherapy and examining the natural history of food allergy in children.CoFAR and of other research groups have demonstrated that oral food allergen immunotherapy has promise as an approach that can allow most children with IgE-mediated food allergy to become desensitized and tolerate substantial amounts of the food to which they are allergic.

However, oral immunotherapy has limitations: it can cause allergic reactions, some patients are not able to tolerate it, and not all patients that are able to tolerate therapy achieve the ability to ingest an appreciable amount of the food allergen in question. Furthermore, there is a small risk for developing Eosinophilic Esophagitis (EoE) while on oral immunotherapy, and many patients are unable to stop therapy without rapidly regaining their food reactivity. Studies are needed to address these challenges and to optimize and test various immunotherapeutic approaches in food allergy. Importantly, determining optimal timing (best age to initiate treatment, duration of treatment) and optimal dosing of food allergen immunotherapy requires careful evaluations. In addition, the immunologic changes that are necessary for a food-allergic patient to acquire durable food tolerance need exploration so that tolerance-focused therapies can be developed. Management of food allergy may benefit from the emergence of multiple immunomodulatory agents that target various aspects of Type 2 immunity. Some of these agents, including adjuvants, could theoretically be combined with allergen immunotherapy to induce therapeutic, antigen-specific immune regulation, deviation or deletion of effector cells.

The LEAP study, conducted by the NIAID-funded Immune Tolerance Network, successfully established the concept of prevention of IgE-mediated peanut allergy by early dietary introduction in infancy. Since then, various studies have suggested that other IgE-mediated food allergies could be similarly prevented. Many questions remain as to the optimal age, dose and frequency for early dietary introduction of allergenic foods. Also, additional concepts on the prevention of IgE-mediated food allergy have emerged that require more definitive testing. For example, does allergenic food consumption during pregnancy or lactation have preventive effects? What is the role of the intestinal microbiome in early infancy, how is it influenced by the mother's microbiome, and can alterations of early life gut microbiome improve immunologic tolerance and reduce food allergy? Other factors, potentially acting through epigenetic or other indirect mechanisms need to be explored.

The oral food challenge remains the gold standard in the diagnosis of IgE-mediated food allergy. This procedure is time-consuming and has risks; therefore, it cannot be conducted in large scale. This diminishes accuracy in the epidemiology and clinical diagnosis of food allergy. Results obtained from in vitro testing, particularly with component diagnostics and newer allergenic epitope methodologies, have yielded promising results and need to be vigorously tested in diverse populations alone or in combination with carefully developed questionnaires in order to create diagnostic algorithms of high positive and negative predictive values.

The spectrum of food-induced allergic conditions is wider than IgE-mediated food allergy and continues to expand. EoE was first reported in 1978 and only recognized as a distinct clinical entity in 1993. At first thought to be a rare disease, the current estimate is that it affects up to 1 in 1,000 people in the US and is the most common cause of food impaction. Food protein-induced enterocolitis syndrome (FPIES) also was first described in the 1970s and is a disease that causes acute and repetitive vomiting, sometimes accompanied by diarrhea, that can be severe enough to cause hypovolemic shock. Alpha-Gal Syndrome (AGS) was only recognized in 2008. It produces reactions that occur after ingesting mammalian meats but are delayed for several hours after exposure. Although, in recent years, significant knowledge has been acquired and therapeutic advances in EoE have been made, the fundamental pathophysiology of this condition remains unknown and additional therapeutic approaches need to be developed. The mechanism(s) of FPIES also are unknown, accurate identification of the offending food(s) and follow-up to assess resolution require oral food challenges with the above-described limitation of these procedures and no specific therapeutics or therapeutic strategies are available. Similarly, although the culprit for AGS is probably allergic sensitization to galactose-?-1,3-galactose, the mechanism of allergic sensitization (currently assumed to be linked to tick bites) requires further examination, the reasons why reactions are delayed are unclear, and therapies are not available.

Objectives and Scope

CoFAR is a clinical network consisting of two distinct entities, the CoFAR Leadership Center (LC) and the CoFAR Clinical Research Centers (CRCs). The two entities will work collaboratively to conduct network-wide, ground-breaking clinical research projects in the areas of prevention, therapy, and understanding of the mechanisms of food allergy. The CoFAR-LC will provide leadership, overall strategy, and support for the network-wide clinical research projects. The CoFAR-CRCs will execute all network-wide clinical research projects.

It is expected that CoFAR will conduct at least two network-wide clinical research projects. At least one of these projects will be a therapeutic or preventive clinical trial. Both the CoFAR-LC and the CoFAR-CRCs will propose network-wide clinical research projects. Once CoFAR is formed, these proposals will be considered by the CoFAR Steering Committee and those to be executed will be chosen by the CoFAR-LC PD(s)/PI(s). The network-wide clinical research projects that the CoFAR will conduct will require approval by NIAID, which will consider programmatic priorities in its decision.

In addition to providing leadership, scientific strategy and organizational structure for the network, the CoFAR-LC will be responsible for distributing protocol funds to the CoFAR-CRCs to execute the network-wide CoFAR clinical research projects. Furthermore, the CoFAR-LC is expected to propose mechanistic research using clinical samples provided by the CRCs as part of the CoFAR clinical research projects to accelerate the translation of basic research advances into clinical applications. All research developed by the CoFAR-LC will involve human subjects.

The CoFAR-LC will propose two clinical research projects. The scope of these projects includes but is not limited to therapeutic or preventive clinical trials focusing on innovative approaches, observational human studies to improve the epidemiology and better understand the pathophysiology of food allergy conditions, and studies to improve food allergy diagnosis. Phase 3 trials are acceptable but will require strong justification and demonstration of feasibility. Focus areas might include:

• Therapeutic or preventive trials of
  • Early allergenic food introduction for the prevention of IgE-mediated food allergy
  • Direct or indirect manipulation of the microbiome
  • Food allergen immunotherapy
  • Drugs, biologics, adjuvants, or devices for the management of food allergy conditions
  • Combinations of the above
• Studies to improve the diagnosis of food allergy aiming at replacing oral food challenges
• Studies to accurately assess the incidence and prevalence of food allergy conditions in diverse populations, in the US
• Studies examining the interactions between immunologic, microbial, environmental, and genetic or epigenetic factors underlying the development of food allergy conditions
• Studies of molecular mechanisms associated with the development and clinical presentation of food allergy conditions or response to therapy (targeted and/or unbiased approaches)
• Studies on the mechanisms underlying severe allergic reactions

Applicants may submit to both the CoFAR Leadership Center and the CoFAR Clinical Research Centers (RFA-AI-22-076). However, the two network-wide clinical research projects proposed in the CoFAR-LC application must be different than the network-wide clinical trials or studies proposed in the CoFAR-CRC application.

The CoFAR-LC will be responsible for ensuring completion of two ongoing CoFAR studies:

CoFAR-11: Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (https://clinicaltrials.gov/ct2/show/NCT03881696). It is anticipated that the trial will be completely enrolled by the end of the current grant and that the last patient last visit will occur by March of 2026.

CoFAR-12: Systems Biology of Early Atopy (https://clinicaltrials.gov/ct2/show/NCT04798079). This observational study is anticipated to complete recruitment in July 2023 and will continue through at least July 2026.

Applications that propose the following topics will be considered non-responsive and will not be reviewed

• Research conducted in animals or animal cells (including humanized mice)
• Research on immunologic or non-immunologic food related diseases other than IgE-mediated food allergy, FPIES, AGS, or EoE, such as celiac disease, irritable bowel syndrome or food intolerances
• Research on HIV/AIDS

Note: Foreign Components may only provide services in support of clinical study or clinical trial activities (e.g., conduct of laboratory assays). Foreign Components must not conduct clinical trials or clinical studies.

Resources provided by NIAID to the CoFAR Clinical Research Network

The following resources will be provided by NIAID to CoFAR for network-wide projects:

NIAID-DAIT funds resources (Centers) that provide a broad range of clinical research services including support for the design and organization of clinical study protocols, data management, biosample repository and management, clinical site monitoring, safety monitoring and reporting, data analysis and manuscript development. The following Centers will be supporting CoFAR:

• NIAID Clinical Data and Safety Management Center (CDSMC)
• Allergy and Asthma Statistical and Clinical Coordinating Center (AA-SCCC)
• NIAID Clinical Site Monitoring Center (CSMC)

Study Drug Distribution Center: NIAID-DAIT funds a study drug distribution center which will store, label, and distribute study drug used for some or all network-wide CoFAR trials.

Clinical Trial Sponsorship: NIAID will be the Sponsor for all network-wide clinical trials and will provide regulatory support.

NIAID-appointed Asthma and Allergy Data and Safety Monitoring Board (DSMB): All CoFAR network-wide clinical trials will be reviewed by the DSMB provided by NIAID. After study initiation, the DSMB will conduct periodic safety reviews.

Public Access to CoFAR Network-Wide Data: All network-wide clinical trial, clinical study, biomarker, and mechanistic data produced by the CoFAR will be made publicly available by NIAID through the CDSMC and the AA-SCCC either via ImmPort or another NIAID-approved resource.

CoFAR Committees

• The CoFAR Steering Committee: Responsible for advising the LC PD(s)/PI(s) on which clinical research projects mechanistic studies should be selected for implementation from among those proposed in the CoFAR-LC and CoFAR CRC applications or any other proposal, approving the final clinical protocols, and modifying or adding protocols as scientifically indicated. The Steering Committee will be composed of the CoFAR-LC PD(s)/PI(s), the PD(s)/PI(s) of the funded CRCs, and PD(s)/PI(s) of the AA-SCCC.
• The CoFAR Protocol Working Group(s): Responsible for development, review, and management of the progress of each CoFAR project, whether a clinical trial or other human study.
• The CoFAR Publications Committee: Responsible for reviewing manuscript proposals, abstracts, posters, and final manuscripts.

Structure of the CoFAR Leadership Center

The CoFAR LC will consist of the following subsections:

• Leadership Center Administration will have the responsibility for the administrative oversight, staffing, and fiscal management of the CoFAR-LC. In addition, the Leadership Center Administration will have responsibility for establishing CoFAR governance and maintaining the CoFAR Committees.
• Leadership Center Clinical Operations will have the overall responsibility of organizing and administering the clinical research projects, which includes development, implementation, and management.Other responsibilities include contracting a central laboratory facility(ies) for measurement of standard biomedical outcomes in food allergy (e.g., IgE) and for routine safety laboratory testing; submission to and other interactions with a central IRB; evaluating and establishing appropriate shipping methods to retain the viability of biosamples; and protocol specific training of all CoFAR investigators and staff, both at the CoFAR-LC and the CoFAR-CRCs, in collaboration with the CoFAR-CRCs, the CDSMC, AA-SCCC and with NIAID staff. Clinical operations will also be responsible for determining protocol funds to be disbursed from the CoFAR-LC to the CoFAR-CRC sites participating in network-wide clinical research projects to support the conduct of those projects.
• Clinical Research Projects are the specific scientific endeavors that CoFAR may pursue as a network. Clinical research projects can be therapeutic or preventive clinical trials or clinical studies. At least one of the two research projects proposed by the CoFAR-LC must be a therapeutic or preventive clinical trial in IgE-mediated food allergy, and the second project may be either a clinical trial or a clinical study, and may be focused on IgE-mediated food allergy, FPIES, AGS, or EoE. All the clinical research projects must include mechanistic research as an integral part of the research. The clinical trials to be implemented will be chosen from among the trials proposed by the funded CoFAR-LC and the funded CoFAR-CRCs. The CoFAR-LC PD(s)/PI(s) will decide which clinical research projects the CoFAR will conduct based on input from the CoFAR Steering Committee. The clinical research projects that the CoFAR will conduct will require approval by NIAID, which will consider programmatic priorities in its decision.It is anticipated that at least two new clinical research projects will be implemented during the course of the CoFAR awards.

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

For more information see the NIAID Research Funding site "Questions and Answers for RFA-AI-22-077" found at the following: FAQs link

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

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

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Foreign Components may only provide services in support of clinical study or clinical trial activities (e.g., conduct of laboratory assays). Foreign Components must not conduct clinical trials or clinical studies.

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

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

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

Applicant Organizations

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

• 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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Applicants may submit to both the CoFAR-LC and CoFAR-CRC (RFA-AI-22-076) funding opportunities. However, different clinical research projects must be proposed in each of the two 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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:

Lindsey Pujanandez, PhD
Telephone: 240-627-3206
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following additional requirements

The Research Strategy must consist of the following sub-sections with the indicated page limits:

Subsection A: CoFAR-LC Overview - 12 pages

Subsection B: CoFAR-LC Leadership Center Administration - 12 pages

Subsection C: CoFAR-LC Clinical Operations - 12 pages

Subsection D: CoFAR-LC Network-wide Clinical Research Projects- two required - 12 pages each

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

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

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

Other Attachments:

Provide a PDF file with the name "Staffing Plan". This should contain a staffing plan for the proposed CoFAR network-wide clinical research projects. The staffing plan should include the staff that will be required at the LC for the proposed projects to be appropriately executed and should indicate the qualifications and expertise that will be required for each position. Positions may include: coordinators for network-wide activities such as day-to-day administration, single IRB activities, project specific training for staff or laboratory support of mechanistic research studies. Separately indicate the staff that will be required at the CRCs for the execution of the same network-wide projects. Do not name individuals or sites.

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

R&R Budget

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

Include funds, with justification, for:

• PD(s)/PI(s)
  • For single PD/PI applications, the PD/PI must commit an overall minimum of 3 person-months for CoFAR-LC activities.
  • For multi-PDs/PIs applications, one of the PDs/PIs must commit a minimum of 2 person-months for CoFAR-LC activities and all other PDs/PIs must commit a minimum of 1 person-months.
    
    
• Clinical Operations CoFAR-LC personnel and CoFAR-LC administration personnel and operating costs
• Single IRB costs
• Travel and other expenses for CoFAR-LC Senior/Key Personnel to attend two (2) one and a half (1.5) day CoFAR Steering Committee meetings per year in the Rockville, Maryland area.
• Funds to be distributed to the previous CoFAR-LC are not expected to exceed $6.5 million in direct costs to be distributed between year 1 and year 2 or as necessary for the continuation and completion of CoFAR-11. (A budget for CoFAR-12 is not requested)
• Purchase of the pharmacologic, biologic, or device-based intervention in a clinical trial (if applicable).
• Protocol funds for 12 CoFAR-CRCs to conduct 2 network-wide clinical research projects (at least 1 project needs to be a clinical trial in IgE-mediated food allergy) and for the mechanistic research sites that the LC will propose. Protocol funds include (but are not limited to) the following protocol specific expenses:
  
  
  • Salary for additional staff beyond core personnel provided in the CoFAR-CRC budgets for network-wide projects (12 person-months of a coordinator and 1 person-months of PI time for network-wide projects)
  • Protocol-specific participant screening and recruitment
  • Study participant retention
  • Protocol required tests and evaluations
  • Study participant reimbursement
  • Equipment and supplies necessary to conduct the clinical trials or studies
  • Shipping costs for biosamples from the CoFAR-CRCs to the biorepository and from the biorepository to mechanistic laboratories
  • Funds for mechanistic research associated with every network-wide clinical research project

R&R Subaward Budget

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

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

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

Specific Aims: List the Specific Aims of the CoFAR-LC focusing on the overall research agenda.

Research Strategy: The research strategy consists of the following subsections

Subsection A: CoFAR-LC Overall

In this narrative section, describe and discuss an overview of the proposed scientific strategy and vision of CoFAR.

• Describe and discuss the scientific goals of the application in the context of recent studies and current knowledge in the field of food allergy and the objectives of this FOA.
• Present a research strategy that builds on previous research and/or stems from novel, well-justified concepts.
• Include data pertinent to the development of the Overall Research Agenda and scientific goals.
• Discuss the rationale of each proposed clinical research project as it relates to the CoFAR Overall Research Agenda and how each clinical project might inform future studies.
• Discuss concepts for potential future studies that may emerge as a result of the findings of each of the proposed clinical research projects. Emphasize innovative elements included in the proposed projects, both in terms of novel interventions, as well as in terms of novel study designs (for example, with incorporation of adaptive designs).
• Provide a table or graphic representation of the combined timeline for all proposed clinical research projects.
• Discuss policies and procedures for the operation of the CoFAR.

Subsection B: Leadership Center Administration:

In this section, describe the administrative structure of the CoFAR-LC as it pertains to communications among investigators and between investigators and staff, the handling of its finances, and the management of CoFAR governance through its Protocol Working Group(s) and Steering Committee.

• Present a concise organizational chart of the administrative structure of the CoFAR Leadership Center Administration. Identify the types of staff associated with each operation and describe their respective roles and responsibilities.
• Provide a detailed plan of the interactions among investigators and between investigators and the Leadership Center Administrative staff with reference to meetings, teleconferences, and other communications. Explain the role of those interactions in the overall functionality of the CoFAR.
• Describe processes and procedures for the fiscal administration of the CoFAR-LC, especially with regard to how protocol-specific funds for the conduct of the clinical research projects will be determined, managed, and disbursed to the 12 CRCs. Describe the process of establishing consortium agreements.
• Describe the management process through which the CoFAR-LC will ensure the continuation and completion of the CoFAR-12 birth cohort along with the final publication of the results.
• Describe plans and procedures to ensure the efficient, timely, and effective review by the single IRB chosen for protocol documents including:
  
  • Describe the flow of communications between the sites, the single IRB and the CoFAR-LC.
  • Describe how site-specific IRB requirements will be handled, including a flow chart that explains single IRB and local IRB communications.
  • Provide timelines for the execution of reliance agreements, and for initial and subsequent review of the protocol and related documents.
    
• Describe plans and procedures for establishing and maintaining the functions of committees responsible for Consortium governance and management, including the CoFAR Steering Committee. In discussing the functions of those committees, propose additional activities such as:
• Developing and implementing policies to ensure the efficient operation and effective management of the functions of the CoFAR, including enforcement of Steering Committee decisions and resolution of disputes and differences of opinion within the Steering Committee.
• Developing and implementing policies and procedures for the identification, disclosure, reporting and management of potential and actual conflicts of interest for members of the CoFAR-LC, CoFAR-CRCs, or investigators with mechanistic studies.
• Developing and implementing policies and procedures for planning, authorship, preparation, review, and final approval of manuscripts resulting from CoFAR-supported studies and for submission of manuscripts for publication in peer-reviewed journals.
  
• Provide a brief plan for leadership succession if the PD(s)/PI(s) is, for any reason, unable to continue as the leader of the program.

Subsection C- Clinical Operations:

In this section, describe the personnel and the procedures and processes that the CoFAR-LC will use for the implementation and management of the proposed clinical research projects.

• Present a concise organizational chart of Clinical Operations that will ensure the CoFAR-LC can meet requirements. Identify the types of staff associated with each operation and describe their respective roles and responsibilities.
• Describe plans and procedures (not the scientific rationale) for the design and execution of the clinical protocols that will be selected for implementation and other clinical document development.
• Describe plans for how the CoFAR-LC will interact with the CoFAR-CRCs and the AA-SCCC and the CDSMC.
• Describe the process through which the CoFAR-LC will choose appropriate CRCs to conduct a particular clinical project.
• Describe the process for contracting a central laboratory facility(ies) for measurement of standard biomedical outcomes in food allergy and for routine safety laboratory testing.
• Define the role of the CoFAR-LC in the organization and implementation of the clinical research projects that the CoFAR will conduct including:
  
  • Development of and adherence to protocol-specific milestones and performance guidelines.
  • Training of CRC investigators and staff in accordance with Federal regulatory requirements, Good Clinical Practice (GCP) guidelines, and International Conference on Harmonization (ICH) standards. Include training on: clinical protocol participant screening, recruitment, enrollment, and retention; informed consent; assessment and reporting of Adverse Events (AE) and Serious Adverse Events (SAE); collection of protocol-specific biologic specimens; receipt, storage, packaging, labeling, and management of study products; collection, quality control, and management of study data; data entry, and creation, maintenance, and storage of research records, including Case Report Forms (CRFs), standard operating procedures, manuals of operation, source documents, regulatory files, and subject identification information.
    
• Describe the process for regularly reviewing CRCs performance and monitoring the progress of the clinical and mechanistic project(s), including:
  
  • Actions to be taken to address problems with recruitment or retention of study participants.
  • Quality control of clinical data collection.
  • Coordination with the AA-SCCC on oversight of collection, transportation, processing, storage, and tracking of biologic samples by the CoFAR-CRCs and the mechanistic study sites.
  • Development of a site monitoring plan and actions to be taken to address problems with GCP adherence.
  • Development of mechanisms for corrective actions including site visits.
  • Interaction with the CDSMC and the AA-SCCC on data management, statistical analyses, and manuscript preparation.

Subsection D: Clinical Research Projects (two required, one of which must be a therapeutic or preventive clinical trial in IgE-mediated food allergy):

List the broad, long-range objectives and goals of each proposed clinical project.

• Discuss in each of the two required projects the clinical and biological significance for the field of food allergy and its role in the overall research strategy of the CoFAR.
• Discuss the rationale for the proposed project, the significance of the problem being studied, and the potential impact of the proposed work. For a clinical trial, indicate how the trial will improve the clinical outcome of patients with food allergy.
• Describe earlier studies that led to the proposed clinical trial or clinical study and provide information or data from preliminary studies that address the need for and the feasibility of the project.
• Outline the hypothesis, objectives, and how the proposed outcomes will address the hypothesis.
• Concisely describe the design of the proposed clinical project, include rationale and process for the selection of the participant population, choice of intervention (if applicable), duration, and schedule of events.
• Discuss each project's feasibility, difficulties that may be encountered, and offer alternative approaches to be implemented, if needed. Provide information on any competing clinical projects underway in the community, conducted either by the PD(s)/PI(s) or other investigators, and their potential influence on recruitment. Discuss any investigational agents with similar mechanism of action currently under development and their potential influence on the proposed clinical trial.
• Include general concepts for sample size determinations and statistical methodologies but, particularly for clinical trials, provide study-specific details in the PHS Human Subjects and Clinical Trial Information Forms. 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.
• For each project, provide a management plan that includes description of the types of personnel at the LC and at the CRC levels involved in conducting the research, personnel involved in data entry and management, pharmacy personnel involved in handling investigational products, and personnel involved in processing and handling of biosamples.
• For all mechanistic work (required for each of the proposed clinical research projects), describe the scientific question(s) (whether hypothesis-generating or hypothesis-driven research), rationale, biosample selection, assay selection, methodology, and analytic approach.
• Discuss the feasibility of the mechanistic work proposed, difficulties that may be encountered, and offer alternative approaches that will be implemented, if needed. Include sample size calculations and statistical methodology.
• If a clinical project incorporates standard biomarker assays, include a concise description of the assays that will be used, including a justification for choosing these assays.
• For multi-visit clinical research projects that are not clinical trials, please provide a description of the study design including the procedures and activities that can occur at each visit (schedule of events).
• Provide details on the source and quantity of biosamples to be obtained, and discuss potential safety and ethical issues in obtaining such samples.
• Outline plan(s) to obtain required study agent(s) (if applicable).
• Discuss anticipated problems and propose approaches to mitigate these.

Letter of Support: If investigational drug(s) are to be provided by the manufacturer at no cost, provide letter(s) of commitment.

Resource Sharing Plan:

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

The following modifications also apply:

• The recipient is expected to make the biological samples, diagnostic products, and other research tools, methods, and materials that they develop under the CoFAR award, available to the research community per policies established by the CoFAR-Steering Committee. Therefore, the Resource Sharing Plan should include a summary of how this will be achieved.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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.
• Investigators are expected to share their CoFAR-supported data publicly through ImmPort or other public portals designated by NIAID. Therefore, the Data Management and Sharing Plan should include a summary of how the applicant will manage data submission and interactions with ImmPort, or other NIH-approved public portal.

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

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 3- Protection and Monitoring Plans

3.1 Protection of Human Subjects

3.1.1 Risks to Human Subjects

3.1.1.b Study Procedures, Materials and Potential Risks:

For all research projects provide the following information:

• Describe the types of biosamples to be collected and the handling of the biosamples at the collection sites (collection, processing, storage, transportation, and quality control measures to assess and ensure sample integrity); list the research laboratories to be used and describe the selection rationale and the qualifications; describe the methodology(ies) to be used for each proposed assay/test and provide evidence of assay feasibility.
• Describe the source and quantity of samples to be obtained, and potential safety and ethical issues involved in obtaining such samples (for example, blood drawing volume limitations); the availability of the biological samples to be studied; how biological samples will be collected, transported, processed, stored, and distributed and what quality control measures will be used to ensure sample integrity for mechanistic studies.

3.3 Data and Safety Monitoring Plan

A data and safety monitoring plan will be developed for every study in collaboration with DAIT-NIAID.

3.4 Will a Data and Safety Monitoring Board be appointed for this study?

For clinical trials, answer question 3.4 "yes". The DAIT Allergy and Asthma DSMB will be the DSMB for monitoring all clinical research projects that the site will conduct that require monitoring.

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 occur at each visit (schedule of events).

Section 5.1- Other Clinical Trial-related Attachments

Describe the plan to obtain required investigational agents.

Delayed Onset Study

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

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

• Awards issued under this FOA will be incrementally funded awards for project periods of up to seven years.
• Grants awarded under this FOA will be excluded from automatic carryover. All carryovers will require prior approval.
• Grants awarded under this FOA will not be provided with no-cost extension authority of the NIH Standard Terms and Conditions of Award. No extensions will be allowed.
• Progress and financial reporting will be required and reviewed annually.
• All funds must be expended within the approved project period.

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof 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. See Section III of this FOA for information on registration requirements.

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 the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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 the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). While each application will be evaluated in its entirety based on one overall impact score per application, the CoFAR Clinical Research Projects within each application will also each receive a separate impact score.

Scored Review Criteria

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

Significance

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

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

Specific for this FOA

CoFAR-LC Overall

• Are the scientific goals of the network presented and justified in the context of recent studies, current knowledge in the field of food allergy, and the objectives of this FOA?

• Is an overall strategy presented that builds on previous research in the field and/or stems from novel, but well justified concepts?

• Are data pertinent to the development of the overall research agenda and the scientific goals of the CoFAR-LC presented and of adequate quality?

• Is the rationale of each proposed network-wide clinical project as it relates to the CoFAR-LC overall research agenda sound?

• Does the application present concepts for potential future studies that may emerge as a result of the findings of each of the proposed clinical research projects?

• Is the provided table or graphic of the combined timeline for all proposed Clinical Research Projects feasible and complete?

• Do the presented policies and procedures for the operation of the CoFAR-LC provide assurances that the network can function efficiently and can conduct its proposed studies?

CoFAR-LC Clinical Research Projects

• Does each proposed clinical research project address an important clinical and scientific topic in the area of food allergy?

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?

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?

Specific for this FOA

CoFAR-LC Administration

• Is the plan for leadership succession if the PD/PI is, for any reason, unable to continue as the leader of the program, appropriate?

• Have the applicants proposed effort that meets the minimum criteria as outlined in the instructions to accomplish the goals of this network?

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?

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

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific for this FOA

CoFAR-LC Administration

• Does the organizational chart of the administrative structure of the CoFAR-LC administration identify the types of staff associated with each operation and does it support sound operations?

• Is a detailed plan of the interactions among investigators and between investigators and the CoFAR-LC administrative staff described and does it support efficiency for the function of the network?

• Are the processes through which the CoFAR-LC will determine protocol-specific funds and the plan for how those funds will be determined, distributed and monitored appropriate?

• Is the management plan outlined for the continuation and completion of CoFAR-12 adequate?

• Do the plans and procedures for establishing and maintaining the functions of committees responsible for the CoFAR governance and management, including the CoFAR Steering Committee, support sound and efficient network operations?

• Is the plan for development of policies and procedures for resolution of disputes and differences of opinion within the Steering Committee appropriate?

• Is the plan for development of policies and procedures for the identification, disclosure, reporting and management of potential and actual conflicts of interest for members of the CoFAR-LC, CoFAR-CRCs, and mechanistic investigators appropriate?

• Is the plan for development of policies and procedures for planning, authorship, preparation, review and final approval of manuscripts resulting from CoFAR-supported studies and for submission of manuscripts for publication in peer-reviewed journals appropriate?

CoFAR-LC Clinical Operations

• Is the organizational chart of Clinical Operations well-thought out and appropriate for the function of the network?

• Are the types of staff associated with each operation and their respective roles and responsibilities acceptable and is the staffing appropriate with respect to expertise and time commitment?

• Are plans and procedures for clinical protocol and other clinical document development appropriate and will they contribute to an expeditious process for CoFAR study implementation?

• Is the process for reviewing CRC performance and monitoring the progress of the clinical and mechanistic project(s) appropriate?

• Are plans and procedures on how the CoFAR-LC will interact with the CoFAR-CRCs, the AA-SCCC and the CDSMC acceptable and are they appropriate for an effective network function?

• Is the process through which the CoFAR-LC will identify the CRCs to conduct a particular network-wide clinical research project appropriate?

• Is the role of the CoFAR-LC in the organization and implementation of the network-wide clinical research projects that the CoFAR-CRCs will conduct adequate?

• Are processes and procedures to ensure that biosamples will be collected, shipped, and stored in a manner that will ensure suitability and availability for the mechanistic studies appropriate?

CoFAR-LC Clinical Research Projects

• For each clinical research project, do the management plans provided include adequate description of the types of personnel involved in conducting the research, data entry and management, handling of investigational products, and processing and handling of biosamples? Are these plans appropriate for the project?

• For each clinical research project, are the proposed mechanistic studies accompanied by appropriate rationale and does each mechanistic study contribute to the value of the clinical project?

• Are the proposed mechanistic study assays established and feasible, considering the multi-center nature of the network-wide clinical research projects?

• If applicable, are adequate descriptions and justifications of biomarker assays provided?

• Is there a clear description of the source and quantity of biosamples to be obtained, and potential safety and ethical issues in obtaining such samples (for example, blood drawing volume limitations)?

• For each clinical project, if applicable, is there a plan to obtain required study agent(s) including evidence of commitment by a manufacturer to provide an investigational drug if part of the plan?

• For each clinical project, does the application discuss anticipated problems and propose approaches to overcome or minimize such problems?

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?

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

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

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

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

Additional Review Criteria

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

Study Timeline

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

Vertebrate Animals

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

Not Applicable

Revisions

Not Applicable

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., 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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications 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 FOA.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

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

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

Determining and coordinating the scientific activities of the network-wide clinical research projects; setting project goals and timelines; accepting and implementing common guidelines proposed by the Steering Committee.

The PD(s)/PI(s) working within the CoFAR-LC structure and with other CoFAR-LC staff will carry out the following functions:

• Developing, implementing and managing a process for allocating CoFAR-LC resources and protocol funds for approved studies, including a plan to recommend reallocation of funds to achieve the scientific goals of CoFAR.
• Establishing and operating the CoFAR Steering Committee.
• Establishing and implementing CoFAR policies and procedures.
• Protocol Development, Review and Approval
  
  • The CoFAR-LC PD(s)/PI(s) will provide all clinical research protocols to NIAID for review and will not implement a protocol until all NIAID approvals are obtained and a NIAID DAIT study initiation notification has been provided.
  • Managing communications between the CoFAR-CRCs and the single IRB.

Data Sharing Responsibilities

• Recipients are expected to make the biological samples, diagnostic products, and other research tools, methods, data, and materials that they develop under CoFAR-LC award available to the research community, per policies established by the CoFAR-Steering Committee and consistent with achieving the goals of the program. Informed consent/assent forms utilized in CoFAR-LC supported clinical trials or studies should reflect this commitment.
• To promote rapid public access to CoFAR-supported data, all CoFAR-LC investigators are expected to share their CoFAR-supported data publicly through ImmPort (https://immport.niaid.nih.gov) or other public portals designated by NIAID and consistent with achieving the goals of the program. The privacy of participants will be safeguarded, and confidential and proprietary information will be protected. The PD(s)/PI(s) are responsible for developing data sharing plans and timelines for implementation to be presented to the CoFAR Steering Committee and to the NIAID Program Official assigned to the grant for approval. Sharing plans and their timelines represent a commitment by the recipients to support and abide by the plan. The PD(s)/PI(s) will establish procedures to ensure that all members of CoFAR-LC and associated scientists conform to the data-sharing plan.
• PD(s)/PI(s) 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 DHHS, PHS, and NIH policies.

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

• Two NIAID Project Scientists will provide guidance and support in the design of research activities, will serve as a resource for protocol design and development, will provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities, will advise in the selection of sources or resources, and will advise in management and technical performance. In CoFAR-LC network-wide clinical research projects that include clinical trials and, in some cases, clinical studies, an NIAID-assigned Project Scientist will also have Medical Monitor responsibilities.
• An NIAID Program Official will be responsible for the programmatic stewardship of the award and will be named in the award notice.
• Two NIAID Project Scientists will be non-voting members of the Steering Committee and participate in all Steering Committee activities, including conference calls, subcommittees and special committees. It is anticipated that decisions in all activities will be reached by consensus and that the NIAID Project Scientists will participate in this process.
• Protocol Review and Approval: All clinical research protocols will be reviewed by NIAID and, depending on their level of complexity and risk, will be further reviewed by the NIAID DAIT Clinical Research Committee and by the NIAID DAIT Data and Safety Monitoring Board (DSMB) or another monitoring body.
• IND/IDE: NIAID will serve as the IND/IDE sponsor for all CoFAR network-wide clinical trials requiring an IND/IDE. As part of NIAID’s IND/IDE sponsor responsibilities, the NIAID Medical Monitor will obtain, through the CDSMC, regular reports on adverse events and protocol deviations and will review all serious adverse events. NIAID will be responsible for reporting safety information in accordance with FDA requirements. Also, NIAID, in cooperation with the CDSMC and the AA-SCCC will prepare and submit the final study reports to the FDA. This role may be delegated by NIAID to another entity (e.g., a collaborating pharmaceutical company).
• Clinical Trial Monitoring: NIAID will monitor compliance with good clinical practices, regulatory compliance, accurate protocol implementation, internal quality assurance, and test agent accountability at the CoFAR-CRCs. At NIAID’s discretion, the NIAID Medical Monitor may request that the DSMB convenes ad hoc to review a serious adverse event or a cluster of adverse events or serious adverse events. The NIAID Medical Monitor may request that the CDSMC conducts for-cause monitoring visits to a CoFAR-CRC. Depending on the nature of the problem, such visits may be conducted by the NIAID Medical Monitor and/or NIAID staff and the PD/PI of the CoFAR-LC may be asked to participate in those visits.
• Study Termination: NIAID reserves the right to terminate or curtail a clinical study or clinical trial and/or the involvement of a particular clinical site for any of the following reasons:
  
  • Risk to subject safety
  • Occurrence of unforeseen safety issues or emerging data indicating a presence of unanticipated toxicity
  • Risks that cannot be adequately quantified
  • The scientific question is no longer relevant, or the objectives will not be met
  • Failure to comply with GCP, federal regulations, or Terms and Conditions of Award
  • Failure to remedy deficiencies identified through site monitoring
  • Inadequate progress in fulfilling the research agenda
  • Slow accrual that may jeopardize study completion within the time frame of the award or negatively influence the scientific validity of the study
  • Reaching a major study endpoint substantially before schedule with persuasive statistical significance
  • In case an interim statistical analysis indicates futility
    
• 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. The original source documentation must be available for external monitoring and discrepancy resolution with the database. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.
• Coordination with Outside Entities: In the occasion a company provides investigational materials for a CoFAR study, NIAID will be responsible for entering into Clinical Trial Agreements with that company.
• External Scientific Advisory Group (ESAG): NIAID will establish an ESAG composed of clinical and basic science investigators. Members of the ESAG will review and offer input on CoFAR network-wide clinical research projects, both during protocol development and during the analysis of results. ESAG members may be invited to attend some CoFAR Steering Committee meetings. The ESAG will submit its recommendations to the NIAID Project Scientists, who will then inform the CoFAR-LC PD(s)/PI(s).

Areas of Joint Responsibility include:

• Research Plans: Implementing, monitoring, and updating the clinical research agenda for CoFAR to ensure consistency and relevance with the NIAID scientific priorities.
• Protocol Development: The CoFAR-LC PD(s)/PI(s) will fully develop the clinical research protocols for the projects supported by this FOA with the participation of the CoFAR Steering Committee, the AA-SCCC, the CDSMC and the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) staff. CoFAR-LC protocols will utilize the protocol templates provided by NIAID.
• Research Activities: Reviewing the CoFAR-LC's research activities and goals on an agreed upon schedule (but no less than once every year). Promoting, evaluating, and executing opportunities to collaborate with other federal or non-federal research sponsors.
• CoFAR Steering Committee: The purpose of this committee is to advise the CoFAR-LC PD(s)/PI(s) on the network-wide clinical research projects to be conducted, approve the final clinical trial and study protocols and modify or add protocols as scientifically indicated. The overall CoFAR scientific plan will be reviewed and updated yearly. In addition, the Steering Committee will develop and implement policies and procedures for publicizing the accomplishments and the data resulting from CoFAR studies to the scientific and lay communities and other relevant audiences. The CoFAR Steering Committee will include the PD(s)/PI(s) of the CoFAR-LC (one of those PD(s)/PI(s) will also serve as the Chairperson), a PD/PI from each of the CoFAR-CRCs, the designated Project Leader of the AA-SCCC and 2 NIAID Project Scientists. All members of the Steering Committee are voting members with the exception of the NIAID Project Scientists. If one individual is the same PD/PI for both a CoFAR-CRC and the CoFAR-LC, s/he will have only one vote.
• Network-wide Clinical Study Implementation and Management: The PD(s)/PI(s) of the CoFAR-LC will work in coordination with the CDSMC and the AA-SCCC, through NIAID, to execute the following tasks related to network-wide CoFAR clinical research projects:
  
• Establish and implement policies and procedures for study management and continuous oversight to ensure adequate rates of human subject recruitment, timely and accurate data collection, and completion of all studies. This will include compliance with clinical site and study monitoring functions carried out by the CSMC and the CDSMC for: (i) site initiation visits; (ii) routine monitoring visits to the clinical study sites and the mechanistic sites on a protocol-specific basis; and (iii) specialized site visits, when deemed necessary (e.g., research pharmacy and laboratory operations and compliance with protocol-specific requirements, for cause or remedial site visits). This also will include PD(s)/PI(s) compliance with the NIAID-designated Medical Monitor-approved corrective/remedial actions resulting from clinical site and study monitoring activities.
• Establish and implement policies and procedures for the preparation and submission of AE and SAE Reports to the CDSMC for initial review and assessment, followed by final assessment and classification by the NIAID-designated Medical Monitor.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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 DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

4. Reporting

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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

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: [email protected] (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: [email protected]

Gang Dong, MD PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3508
Email: [email protected]

Lindsey Pujanandez, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3206
Email: [email protected]

Nicole Gormley
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5449
Email: [email protected]

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 45 CFR Part 75 and 2 CFR Part 200.