Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Consortium for Food Allergy Research (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-AI-09-039

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

RFA-AI-14-003

Companion Funding Opportunity

None  

Number of Applications

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

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

93.855; 93.856 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications from single institutions to administer a multi-project multi-institution program, to conduct clinical research and assume the leadership and administrative responsibilities for the Consortium for Food Allergy Research (CoFAR). The selected applicant will continue the mission of the CoFAR, which focuses on immune and other intervention strategies for the prevention and treatment of food allergy, including food allergen-associated severe allergic reactions and anaphylaxis, and food allergen-associated eosinophilic esophagitis. The Consortium will conduct interventional trials with associated mechanistic studies, and observational/natural history and/or genetics studies with associated mechanistic studies, in order to understand better the immunopathogenesis of these conditions. 

Key Dates
Posted Date

February 26, 2014

Open Date (Earliest Submission Date)

May 19, 2014  

Letter of Intent Due Date(s)

May 19, 2014  

Application Due Date(s)

June 19, 2014, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2014   

Advisory Council Review

January 2015  

Earliest Start Date

June 2015 

Expiration Date

June 20, 2014  

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

This FOA solicits applications from single institutions to administer a multi-project multi-institution program, to conduct clinical research and assume the leadership and administrative responsibilities for the Consortium for Food Allergy Research (CoFAR). The selected applicant will continue the mission of the CoFAR, which focuses on the prevention and treatment of food allergy, including food allergen-associated severe allergic reactions and anaphylaxis, and food allergen-associated eosinophilic esophagitis. The Consortium will conduct interventional trials with associated mechanistic studies, and observational/natural history and/or genetics research with associated mechanistic studies, in order to understand better the immunopathogenesis of these conditions.

The CoFAR organization will comprise multiple components to carry out the broad scope of research delineated above. These are:

Administrative Core – The Administrative Core will be responsible for the overall scientific leadership and administrative functions of the Consortium and coordination of the other components. This includes naming a supervisor for the Laboratory Program who will be responsible for standardization and quality control for routine clinical laboratory testing and monitoring, in all studies supported under this Consortium. The Administrative Core will have also the responsibility for establishing and maintaining the following committees/groups: Consortium Investigator Committee, Consortium Steering Committee and External Scientific Advisory Group.

Clinical Projects –This FOA divides clinical projects into two categories: interventional clinical trials and projects which are not interventional clinical trials; the latter category is referred to as either “non-interventional clinical studies” or as “clinical studies”. Applicants should propose 4 required clinical projects, and may propose up to 2 other, optional clinical projects.

Background

Food allergy is a common immune-based disease that has become a serious health problem in the United States and other developed countries. The estimated prevalence of food allergy in children ranges from 4 to 8% and between 1997 and 2011, prevalence has increased 1.5-fold. In addition, recent epidemiologic data suggest that allergy to milk and egg, the most common food allergies in infants, appears to be resolving at an older age than in earlier studies. The onset of most food allergies is during childhood, but some (e.g., crustacean seafood allergy) have onset in adulthood. Food allergy is associated with severe, including life-threatening allergic reactions (anaphylaxis). Indeed, among certain cohorts of highly allergic children, accidental exposure results in approximately one reaction per subject per year, and 11% of such reactions are severe. Moreover, of emergency room visits for anaphylaxis, between 13% and 65% are caused by allergic reactions to food allergens. Peanut followed by tree nuts are the most common causes of death from food-induced anaphylaxis. In addition, the severity of food allergy does not correlate with measures of food allergy such as the level of IgE antibody to allergen, indicating that there are many gaps in current knowledge of the mechanisms of food-induced anaphylaxis. Despite these important public health concerns about food allergy, there is no approved therapy except to avoid food allergens and to treat severe allergic reactions with epinephrine.

Eosinophilic esophagitis (EoE) is another increasingly common food-associated disorder characterized clinically by refractory heartburn, dysphagia and food impaction.  Food impaction affects between 35 and 55% of adolescents and adults with EoE, and, conversely, EoE is responsible for 39-53% of food impaction episodes in children.  EoE is strongly associated with other allergic disorders, including food-associated anaphylaxis, and responds to food avoidance or an elemental diet in many cases; however the mechanisms responsible for this disease or its relationship to food allergy remains unclear.

The need for a separate initiative devoted to human food allergy research was emphasized by two successive NIH expert panels on food allergy in 2003 and 2006. To address this need, in 2005 NIAID established the Consortium for Food Allergy Research (CoFAR), a major clinical network to support food allergy research that is now nationally and internationally recognized for carrying out this research.

The current CoFAR (FY2010-2015) consists of 6 clinical centers. The objectives of the 2010 initiative were to support clinical research and mechanistic studies to prevent and treat food allergy, including food allergen-associated EoE, and to study the genetics of food allergy. In addition CoFAR also supports a single project grant to study the genetics of food allergy.

The CoFAR is conducting, or has completed, the following trials and studies:

There have been important recent advances in food allergy research, so it is anticipated that substantial advances in prevention and treatment of food allergy can be made in the future. Experts participating in two NIAID immunotherapy workshops in 2010 and 2012 underscored the importance of continuing to develop and evaluate therapies for food allergy. While preliminary data from clinical trials, mostly of oral immunotherapy, are promising, these experts were unable to identify one immunotherapeutic approach that was clearly superior to other potential approaches. Moreover, there is a subset of patients that has not received any benefits from these therapies and appears to be unable to become desensitized despite repetitive oral administration of allergen. In addition, at least one recent publication has suggested that the duration of benefit from oral immunotherapy may be shorter than anticipated.

The expert panelists acknowledge the need to investigate several mechanistic questions, including whether food allergen immunotherapy achieves only short-term benefits (desensitization) which are reversed when therapy is discontinued or, alternatively, achieves long-term changes in responsiveness to allergen, analogous to tolerance. The mechanisms underlying both desensitization and tolerance are poorly understood and in need of further exploration.

Research Studies and Objectives

This 2015 FOA will support a single U19 award; it will no longer support U01 applications. The FOA will continue the work of the 2010-2015 Consortium for Food Allergy Research with a focus on clinical trials. The objectives of the CoFAR research program are to: explore the pathophysiology of human IgE-mediated food allergy and the related conditions, IgE-mediated food allergy-associated anaphylaxis and IgE-mediated food allergy-associated EoE, and to develop and evaluate clinical approaches to prevent and treat these diseases, and to use integrated state-of-the-art studies to learn more about the mechanisms of these diseases. Under the CoFAR program, applicants are encouraged to develop close interactions among basic scientists and clinical investigators and accelerate the translation of basic research advances into clinical application. It is expected that the proposed research program will support clinical research (clinical trials, observational/natural history studies, and/or genetic studies) and will include state-of-the-art mechanistic studies that are well-integrated within the trials.

Research Studies

All research involves human subjects, with rare exceptions described below.  The applicant should submit clinical and mechanistic study projects with the understanding that the specific studies to be conducted may differ from what is proposed, as a result of peer review, external scientific advisory recommendations, safety reviews by the NIAID Division of Allergy, Immunology and Transplantation Clinical Research Committee (DAIT CRC) and by an independent, NIAID-appointed safety committee, either the Allergy and Asthma Data and Safety Monitoring Board (DSMB) or the Allergy and Asthma Safety Monitoring Committee (SMC), and/or the priorities of NIAID.

The work of the CoFAR will be conducted by the Clinical and the Mechanistic sites with oversight by the Administrative Core.

The Clinical Study Sites must have:

The Mechanistic Study Site(s) (these sites may be identical to, or different from, the clinical study sites) must provide:

The clinical and mechanistic studies should not duplicate ongoing or previously completed studies, including CoFAR studies, and should provide new insights into food allergy. The number of Clinical Study Sites participating in a clinical or mechanistic study can range from 1 to all Clinical Study Sites that will participate in the consortium.  It is expected that multiple studies will be performed concurrently.

Human subjects research will be either as part of a clinical trial or observational/natural history study or genetic/microbiome study, or for collection of samples for mechanistic studies. Both Interventional Clinical Trials and Clinical Studies projects should include mechanistic studies. Clinical projects that are associated with non-interventional clinical studies may use samples from either new cohorts or from pre-existing cohorts.

Scope of Research for the Clinical Projects

Clinical projects include both interventional clinical trials for prevention or treatment, and clinical studies such as observational studies and genetic studies. Mechanistic studies involve human subjects and are defined as aiming at 1) understanding the mechanisms of disease, and/or 2) understanding the mechanisms of action of a treatment modality, and/or 3) identifying biomarkers that predict disease severity or progression from sensitization to allergy, or that predict the ability of a treatment modality to affect efficacy or safety.

The scope of research for clinical projects and associated mechanistic studies supported by this FOA includes, but is not limited to, the following:

Projects with Interventional Clinical Trials and Associated Mechanistic Studies

Interventional Clinical Trials

Mechanistic Studies

Projects with Non-Interventional Clinical Studies and Associated Mechanistic Studies

Clinical Studies

Mechanistic Studies

Coordination and Completion of ongoing Clinical Trials (CoFAR6 and CoFAR7)

These are ongoing interventional clinical trials with recruited patient populations who are receiving therapy; the CoFAR Grantee will be required to establish subcontracts with the Institutions currently completing the trials, and to work with the NIAID medical monitor and nurse/project manager to be certain that the studies will be completed.

This FOA will not support:

NIAID Sources of Support: Certain sources of support for the Consortium will be provided by NIAID under separate awards and costs for such sources of support should not be requested in response to this FOA.  These are detailed below:

The CoFAR will be supported by a Statistical and Clinical Coordinating Center (SACCC) through an independent NIAID award. The SACCC will provide a broad range of clinical research support services, including support for the design and organization of each CoFAR protocol, development of protocol-related materials, data collection, management and quality control, clinical site monitoring, safety monitoring and reporting, data analysis and manuscript development support.

NIAID will serve as the Sponsor for the CoFAR clinical trials conducted under Investigational New Drug (IND) Applications and Investigational Device Exemptions (IDEs) with full responsibility for carrying out sponsor regulatory requirements.  Under certain circumstances, this role may be delegated by NIAID to another entity (e.g., a collaborating pharmaceutical company).

All clinical trials and clinical studies to be conducted by the CoFAR will be reviewed post award by an internal NIAID committee, the Division of Allergy Immunology and Transplantation Clinical Research Committee (DAIT CRC) and also by an NIAID-appointed safety committee, either the Asthma and Allergy Data and Safety Monitoring Board (DSMB) or the Asthma and Allergy Safety Monitoring Committee (SMC). In addition, these committees may review interim and final clinical trial data per protocol or ad hoc to ensure the safety of study participants.  The DSMB and SMC make recommendations directly to NIAID program staff.

All clinical trial and mechanistic data produced by this consortium will be made publicly available by NIAID, through the SACCC, within 18 months after database lock.  NIAID will provide the resource for public access, either through ImmPort (https://immport.niaid.nih.gov/immportWeb/home/home.do?loginType=full) or through another NIAID resource. 

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Renewal

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

Funds Available and Anticipated Number of Awards

NIAID intends to commit $6.1 million in FY 2015 to fund one award.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.  

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 7 years.    

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

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

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Louis A. Rosenthal, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Drive Room 3246
Bethesda, MD 20817
Telephone: 301-402-8399
Email: rosenthalla@niaid.nih.gov  

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

30 pages

Admin Core

12 pages

Project (Clinical Projects)

12 pages for each project


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

Instructions for the Submission of Multi-Component Applications

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

The application should consist of the following components:

Overall Component

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan          (Overall)

Specific Aims:   List the Specific Aims of the Consortium focusing on the overall research agenda and strategic plan.   

Research Strategy: This narrative section is an overview that discusses the overall coordination for the development, review, implementation and execution of interventional clinical trials, non-interventional clinical studies and mechanistic studies including integration with the overall Consortium agenda and strategic plan.  Applicants should also discuss experience or preliminary data (relevant preliminary data for each project should be included not only here, but also in the description of the individual project) and specifically address how they would accomplish the following:

Interventional Clinical Trials and Non-interventional Clinical Studies: Planning and Implementation: Describe concisely the overall rationale and strategic plan for the clinical program and include plans and procedures for the development, review, implementation and execution of clinical program activities. Address each of the following:

Rationale and strategic plan for the clinical trials/studies:

Protocol Development:

Clinical Trial/Study Sites:

Protocol management: directing, monitoring, and managing the implementation of approved clinical studies and trials including the following tasks:

Clinical Trial/Study Implementation and Management: assisting with the coordination to execute the following tasks:

Mechanistic Studies associated with the clinical projects: Planning and Implementation

Describe concisely the plans and procedures for the following:

Rationale and strategic plan for proposed mechanistic studies:

Mechanistic Study Sites:

Protocol Development:

Protocol Management:

Protocol-specific Training:

Assisting in the organization and conduct of protocol-specific training for the participating investigators and the relevant clinical and technical Clinical Study Site and Mechanistic Study Site staff. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification: 

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

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

Project Narrative:  Do not complete

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

List all performance sites that apply to the specific component.

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

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

Budget (Administrative Core)

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

The Program Director/Principal Investigator (PD/PI) will be required to commit a minimum of 3 person months effort per year to the project.

Applicants are requested to budget for: (1) centralized operational, administrative and fiscal support of the Consortium; and (2) continuation and completion of the EoE database and storage of samples from previous CoFAR studies including the biobank from CoFAR5.

For fiscal year 2015, $2 million total costs and for FY 2016, $1 million total costs of the budget for this FOA must be set aside for the completion of two ongoing clinical trials, CoFAR6 and CoFAR7.

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

PHS 398 Research Plan          (Administrative Core)

Specific Aims:  List the Specific Aims of the Administrative Core.  

Research Strategy:  In this section describe the fiscal, administrative and management responsibilities of the Administrative Core

Applicants should describe plans, processes, and procedures for the following activities:

Committees: Within the governance and management structure, the Administrative Core will have responsibility for establishing and maintaining the following committees/groups:

Publications and Communications Policy

External Scientific Advisory Group (ESAG)

The recommendations by the ESAG shall be submitted to the Consortium Steering Committee Chairperson.  The designated NIAID project scientist will be kept informed as to the outcome of these recommendations. All such recommendations shall be considered advisory and shall not be binding on the decisions made by the Consortium Steering Committee. Applicants should describe plans, processes, and procedures for the following activities:

For a new application, do NOT contact, recruit, or name potential members.  For a renewal application, provide the names of current and former members but do NOT contact, recruit or name potential NEW members. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

Clinical Projects

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

Applicants should propose 4 required clinical projects, and may propose up to 2 additional, optional clinical projects. At least 2 required projects must be interventional clinical trials (either a treatment trial or a primary prevention trial), each with associated mechanistic studies. Of the 2 required interventional clinical trials, at least 1 must focus on research on IgE-mediated food allergy (i.e., not food allergy-associated anaphylaxis or food allergy-associated EoE). The remaining projects (including the 2 optional clinical projects) may be additional interventional clinical trials, or observational/natural history studies or other clinical studies that do not involve treatment or intervention.

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

SF424 (R&R) Cover (Clinical Projects)

Complete only the following fields:

PHS 398 Cover Page Supplement (Clinical Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Projects)

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

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

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Clinical Projects)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Clinical Projects)

Budget (Clinical Projects)

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

Note that application should include a full budget for the entire proposed period of support. Budgets should be based on per patient costs and include the other costs of performing the study (clinical research tests, coordinator and Project Lead time, drug costs if applicable, pharmacy costs, etc.). The costs for mechanistic studies should be included here. The costs for data collection and management, statistical support and monitoring and other costs associated with study management will be covered by the SACCC.

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

PHS 398 Research Plan (Clinical Projects)

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

Research Strategy: Use this section to describe how the proposed research will contribute to meeting the Consortium goals and explain the approach and rationale for selecting the methods to achieve the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application and its role in the overall research strategy of the Consortium. For each project, include any preliminary data that support the proposed research.  

Note that all clinical projects must have integrated mechanistic studies. The mechanistic studies must be described within the context of the proposed clinical trial and clinical study project(s). Mechanistic studies presented outside a clinical project are not within the scope of this announcement. It is expected that the mechanistic studies will use state-of-the-art approaches and will evolve in parallel with technological advances. Mechanistic studies will be performed at specialized laboratories with expertise in the appropriate technologies.

It is expected that technologies that accommodate small blood volumes will be used wherever possible for the proposed studies. For clinical studies involving multiple sites, it is expected that state-of-the-art laboratory assays (e.g., basophil activation assays, assays of immune function, immune profiling, etc.) will be performed at a well-equipped central facility at one of the network sites. This central facility requirement is essential to ensure uniform processing of human samples and quality control.

The proposed clinical and mechanistic studies must not exceed the clinical and scientific resources of the applicant’s team of institutions (e.g., the applicant group must be able to recruit the required number of study subjects from within their collaborating institutions).

Clinical Projects (Interventional Clinical Trials and Non-interventional Clinical Studies, with integrated Mechanistic Studies):

The interventional clinical trials and non-interventional clinical studies should be presented in sufficient detail to allow reviewers to judge significance, approach, innovation and environment. Do not submit a detailed, final clinical protocol because, if an award is made, the protocol will be developed collaboratively as a result of initial peer review, external scientific advisory review, DAIT/NIAID CRC review, DSMB or SMC review, according to NIAID priorities.

This Research Strategy section should include the following:

A discussion of the significance of the problem being studied, the need for the clinical trial/clinical study, and the potential impact of the proposed work. For interventional clinical trials, indicate how the trial will improve food allergy clinical status.

A discussion of studies that led to the proposed clinical trial/clinical study and information or data from preliminary studies which address the need for and the feasibility of the project.

A concise description of and rationale for the proposed study design, including how the associated mechanistic studies might inform the conduct of the study.

This should include:

For each mechanistic investigation include a concise description of the following:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report  (Clinical Projects)

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

PHS 398 Cumulative Inclusion Enrollment Report (Clinical Projects)

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The overarching goal of this FOA is to further clinical and mechanistic research on the prevention and treatment of food allergy, including food allergen-associated severe allergic reactions and anaphylaxis, and food allergen-associated eosinophilic esophagitis. A key feature of the FOA is the integration of clinical protocols with mechanistic studies. In this context, a critical question is whether the applicants have assembled a team of investigators capable of conducting state-of-the-art clinical and mechanistic studies of the immunopathogenesis of food allergies, including food allergen-associated severe allergic reactions and anaphylaxis, and food allergen-associated eosinophilic esophagitis

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project  to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project  proposed).

Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, but will not give a separate score for each.

Overall Impact –Individual Clinical Projects

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for each clinical project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Individual Clinical Projects

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

Significance

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

Investigator(s)

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

Have the investigators proposed clinical site leaders with a strong history and experience in successfully designing and conducting interventional clinical trials and non-interventional clinical studies in humans and support personnel capable to execute clinical protocols?

Have the investigators proposed mechanistic site leaders with a strong history and experience in conducting mechanistic research necessary to carry out the scope of the Consortium’s immunologic research relevant to food allergy immunopathogenesis and immunotherapeutics and technical personnel with immunology and molecular biology laboratory experience for research using human biologic samples, including appropriate GCP/IHC training in handling human biologic samples? 

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 

Do the clinical trials, clinical and mechanistic studies conform to the overall strategic plan outlined in the Research Plan and Administrative Core?

Is the study design for the interventional clinical trials, non-interventional clinical studies and associated mechanistic studies of high quality? Have the investigators demonstrated that they are feasible (including having relevant preliminary data)? Are plans for development, review, implementation, execution and management of interventional clinical trials and non-interventional clinical studies and associated mechanistic studies adequate, including, protocol development, selection and management of clinical and mechanistic study sites?

If animal studies are proposed, do they demonstrate a direct link to ongoing or planned human studies? Do they provide critical validation (e.g., proof of principle, pre-clinical safety data, and pharmacological/toxicological data) for subsequent human research studies, or provide clinical trials or clinical studies with background data for subsequent human laboratory methodologies?

Are state-of-the-art technologies and assays used in the mechanistic studies?

Are adequate statistical analysis plans included?

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?   

Are adequate plans in place for training of investigators and staff at Clinical and Mechanistic Study Sites?

Overall Impact – Administrative Core

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Administrative Core 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 core proposed).

Review Criteria – Administrative Core

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

Additional Review Criteria - Overall, Projects, Administrative Core

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable  

Renewals

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

Revisions

Not Applicable 

Additional Review Considerations - Overall, Projects, Administrative Core

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

Applications from Foreign Organizations

Not Applicable 

Select Agent Research

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

Resource Sharing Plans

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

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 NIAID, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

The PD/PI will provide for the overall management, integration and coordination of all activities. The PD/PI will establish an Administrative Center composed of the PD/PI and financial and administrative personnel to carry out the following functions:

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

Areas of Joint Responsibility between NIH and Awardees include:

Consortium Investigator Committee

The investigator committee includes the PD/PI of the CoFAR, the PD/PI of the Statistical and Clinical Coordinating Center, both clinical and mechanistic investigators at all study sites, and designated NIAID staff assigned to each project.

Consortium Steering Committee

The voting members of the Steering Committee will include the PD/PI of the U19, the PD/PI of the SACCC, three investigators chosen by the PD/PI of the U19 who are either Clinical Trial Site and/or Mechanistic study site projects leaders and up to two NIAID-designated Project Scientists.

External Scientific Advisory Group (ESAG)

The members of the ESAG will be selected from institutions outside those serving as members of the Consortium The ESAG should include expertise in the areas of food allergy pathophysiology, eosinophilic esophagitis, genetics, molecular biology, mucosal immunology and basic immunology, immunotherapeutics, clinical trials, and mechanistic studies in human immunologic diseases.

Responsibilities of the ESAG will include:

Publications and Communications Policy

After the grant award, the Steering Committee will develop and implement policies and procedures for planning, authorship, preparation, review and final approval of manuscripts resulting from Consortium-supported studies and for submission of manuscripts for publication in peer-reviewed journals. All final manuscripts must be submitted to the NIAID for review in advance of journal submission. The respective roles, rights and responsibilities of pharmaceutical and medical device companies providing investigational materials for Consortium-sponsored studies in the publication review process will be specified in Clinical Trial Agreements (CTAs) between NIAID and the company.

In addition, the Steering Committee will develop and implement policies and procedures for publicizing the accomplishments and the data resulting from Consortium sponsored studies to the scientific and lay communities and other relevant audiences.

Public Access to Data Generated by the Consortium

All clinical trial and mechanistic data produced by this consortium will be made publicly available by NIAID, through the SACCC, within 18 months after database lock.  NIAID will provide the resource for public access, either through ImmPort (https://immport.niaid.nih.gov/immportWeb/home/home.do?loginType=full ) or through another NIAID resource.

Protocol-specific Training

Prior to the initiation of any clinical study, the Protocol Chair will organize and conduct, with the support of the Consortium Statistical and Clinical Coordinating Center, protocol-specific training for the participating investigators and the relevant clinical and technical clinical study site and mechanistic site staff. Training will include face-to-face meetings and teleconferences.

Clinical Study Implementation and Management

The PD/PI will work in coordination with the Consortium Statistical and Clinical Coordinating Center to execute the following tasks:

All policies and procedures delineated above will be approved by the Consortium Steering Committee prior to implementation.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Michael Minnicozzi, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3532
Email: minnicozzim@mail.nih.gov

Peer Review Contact(s)

Louis A. Rosenthal, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-8399
Email: rosenthalla@niaid.nih.gov

Financial/Grants Management Contact(s)

Chernay Mason
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-2068
Email: masoncl@od.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92 .


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