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). 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 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

Food allergy is a common immune-mediated disease that has become a serious health problem in the United States and other developed countries. The estimated prevalence of food allergy ranges from 4 to 8% in children and is approximately 5% in adults. Over the past 2 decades, the prevalence in children has increased substantially. Food allergy is associated with severe and sometimes life-threatening allergic reactions (anaphylaxis). 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. It is not possible to predict which individuals are at risk of life-threatening reactions. There is no FDA approved therapy for food allergy; avoidance of food allergens and treatment of food allergy-induced systemic reactions with epinephrine remain the standard of care.

In 2005, NIAID established the Consortium for Food Allergy Research (CoFAR), which was re-competed and renewed in 2010. 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 and the genetics and epigenetics of food allergy.

While there is evidence that genetic traits play a role in food allergy, these factors cannot explain the increase in the prevalence of the disease. Other factors need to be investigated. For example, research on the role of the intestinal microbiome, which could be influencing the induction of tolerance via the gastrointestinal immune system, is needed. It may also be important to examine whether food allergen avoidance, by reducing exposure of the gastrointestinal immune system to antigen, limits the chances for the development of food tolerance.

Through the work of CoFAR and that of other research groups, oral food allergen immunotherapy has shown promise as an approach that can allow the majority of children with food allergy to become desensitized and tolerate substantial amounts of the food they are allergic to. However, oral immunotherapy can cause a relatively high rate of allergic reactions and a number of patients are not able to pass the final oral food challenge that most studies include. Furthermore, there is a small risk for developing eosinophilic esophagitis, 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. In addition, the mechanisms underlying acquisition of desensitization (lack of response to the food during continued exposure to the food), sustained unresponsiveness (lack of response to the food even in the absence of exposure to the food), or acquisition of durable immunologic tolerance are poorly understood, and are all in need of further exploration.

Management of food allergy may benefit from the emergence of a number of immunomodulatory agents that target various aspects of Th2 immunity. Many of those agents are currently in clinical development for other forms of allergic disease, but their testing in food allergy should not be delayed. 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.

Recent evidence indicates that early introduction of allergenic foods in susceptible populations is highly efficacious in preventing food allergy. The Learning Early about Peanut Allergy trial conducted by the NIAID’s Immune Tolerance Network tested strategies to prevent peanut allergy in high-risk infants. This trial demonstrated that, compared to at-risk children who avoided peanut consumption, those who regularly consumed peanut-containing foods beginning at age 4-11 months had an 81% relative reduction at age 5 in the prevalence of peanut allergy. Further investigation of strategies for food allergy prevention, including the underlying mechanisms, is needed.

The Consortium for Food Allergy Research (CoFAR) consists of two distinct entities, the CoFAR Leadership Center (LC) and the CoFAR Clinical Research Units (CRUs). The objectives of the CoFAR CRUs are to provide the CoFAR with clinical trial and study opportunities, in order for the CoFAR to conduct ground-breaking research in the areas of prevention and treatment of food allergy and understanding of its underlying mechanisms. To advance these objectives, the CoFAR CRUs will work in collaboration with the CoFAR LC to conduct the CoFAR clinical projects, whereby the CoFAR LC will provide scientific strategy and organizational structure. Each CoFAR CRU will also propose a multi-center, cutting edge clinical trial. Clinical monitoring, data collection, data management, and statistical support for this effort will be provided by the NIAID-DAIT: Statistical and Clinical Coordinating Center. CoFAR CRUs will also be expected to provide a rich environment for New and Early Stage Investigators to develop research skills and to assist them in progressing to more senior status through their work in CoFAR.

It is anticipated that at least three clinical projects will be implemented during the course of the CoFAR awards. At least two will be clinical trials and the third project may be either a clinical trial or a clinical study. For the purpose of this FOA, a clinical trial is defined as a research study in humans that evaluates the effects of one or more interventions for the treatment or prevention of IgE-mediated food allergy. The clinical trials to be implemented will be chosen from the trials proposed by the CoFAR LC and the CoFAR CRU awardees. The LC PD/PI will decide which clinical projects, or revisions to proposed projects, the CoFAR will conduct based on input from the CoFAR Steering Committee of which all funded CRU PD/PIs will be voting members. The clinical projects that the CoFAR will conduct will require approval by NIAID, which will consider programmatic priorities in its decision.

The scope of the multi-center clinical trial proposed under this FOA includes but is not limited to, the following:

• Phase I or Phase II clinical trial for either treatment or prevention of food allergy focused on immune-based approaches such as preventative early allergen exposure, new forms of allergen immunotherapy including immunotherapy in combination with adjuvants, anti-cytokine treatment, or other immunomodulatory agents/approaches.
• Phase III clinical trials will be allowed only following successful completion of a phase II trial.

The scope of clinical trials and studies that the CoFAR CRUs will implement for the CoFAR LC includes, but is not limited to, the following:

• Phase I and/or Phase II clinical trial(s) for either treatment or prevention of food allergy. Clinical trials should focus on immune-based approaches such as preventative early allergen exposure, new forms of allergen immunotherapy including immunotherapy in combination with adjuvants, anti-cytokine treatment, or other immunomodulatory agents/approaches.
• Phase III clinical trials will be allowed only following successful completion of a phase II trial.
• Birth cohort studies of individuals at high risk vs. low risk of food allergy.
• Cross-sectional or long-term clinical studies in individuals with food allergy.
• The role of the microbiome in the pathogenesis of food allergy.
• Identification of the route of allergen sensitization in food allergy.
• Interactions between immunologic, environmental and genetic or epigenetic factors underlying food allergy.
• Proteomic and/or metabolomic profiling in association with the clinical presentation of food allergy.
• Molecular mechanisms (e.g. analysis of signaling pathways) in association with the clinical presentation of food allergy.
• Mechanisms underlying the severity of allergic reactions and anaphylaxis in food allergy.

This FOA will not support:

• Research conducted in animals or animal cells.
• Research on eosinophilic esophagitis.
• Research on non-IgE mediated diseases such as celiac disease.
• Research on HIV/AIDS.

Applications which include the topics listed above will be deemed non-responsive and will not be reviewed.

Resources provided by NIAID to the CoFAR

The NIAID-DAIT: Statistical and Clinical Coordinating Center (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.

NIAID will serve as the Sponsor for the CoFAR clinical trials conducted under Investigational New Drug (IND) Applications 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 NIAID-appointed Asthma and Allergy Data and Safety Monitoring Board (DSMB). In addition, the DSMB will conduct periodic safety reviews.

NIAID will provide for public access, either through ImmPort or through another NIAID resource and all clinical trial, clinical study, biomarker and mechanistic data produced by CoFAR will be made publicly available by NIAID, through the SACCC, at the time of publication of the primary outcome of the study or 18 months after database lock, whichever comes first.

CoFAR Committees

• The CoFAR Investigator Committee: Responsible for review and management of progress of CoFAR projects including clinical trials and studies.
• The CoFAR Steering Committee: Responsible for informing NIAID of the final clinical trial and observational study protocols and modification or addition of in-scope protocols as scientifically indicated.

Structure of the CoFAR Clinical Research Units

Every CRU will consist of an Administration and Operations element and a Clinical Trial element. Both the Administration and Operations and Clinical Trials elements are critical to the success of the CRU.

Administration and Operations element:

A. Planning and Coordination: Responsible for coordinating the activities of the CoFAR CRU as well as interfacing with the CoFAR LC in the organization of clinical trials implementation and associated fiscal responsibilities. The CoFAR CRU Institutions are encouraged to have IRB policies allowing for federated IRB models, which are likely to be used for the CoFAR clinical studies. Further, the CoFAR CRUs should have established policies and procedures for study management and continuous oversight to ensure timely and accurate data collection, and policies and procedures to ensure the safe and ethical conduct of clinical research in accordance to Federal regulatory requirements, cGCP and ICH guidelines. Finally, the CoFAR CRU is expected to have a track record supporting and promoting new clinical investigators in food allergy research. The Planning and Coordination section is responsible for nurturing New and Early Stage Investigators during the period of the CoFAR CRU award.

B. Research Operations: Responsible for the execution of the CoFAR clinical projects including: a) Maintaining a clinical research team capable of conducting trials and other clinical studies in food allergy and

b) Maintaining a rich database of patients for food allergy research.

Clinical Trial element: Responsible for proposing one clinical trial to be conducted by CoFAR.

CoFAR Protocol Funds:

Additional protocol specific funds will be disbursed by the CoFAR LC to the CRUs participating in each of the clinical projects. Protocol funds include (but are not limited to) the following protocol-specific expenses:

• Salary for additional staff or expanded commitment of core staff.
• Protocol-specific participant screening and recruitment.
• Patient retention.
• Protocol required tests and evaluations.
• Participant reimbursement.
• Equipment and supplies necessary to conduct the clinical trials and clinical studies.

For more information see the NIAID Research Funding site Questions and Answers for RFA-AI-15-051 found at the following:

http://www.niaid.nih.gov/researchfunding/qa/Pages/RFA-AI-15-051.aspx#

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.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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 not 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.

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

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

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

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.

The PD(s)/PI(s) of a CoFAR Leadership Center (RFA-AI-15-050) or the CoFAR Clinical Research Units (RFA-AI-15-051) may be the same individual(s).

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

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

Institutions may submit an application to both the CoFAR Leadership Center (RFA-AI-15-050) and the CoFAR Clinical Research Units (RFA-AI-15-051). However, the same clinical trial cannot be proposed in both RFAs.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must download 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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. 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.

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Louis Rosenthal, Ph.D.
Telephone: 240-669-5070
Fax: 301-480-2408
Email: [email protected]

Page Limitations

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

For this specific FOA, the Research Strategy should consist of the following sections with the indicated page limits:

• Administration and Operations: 12 pages
• Clinical Trial: 12 pages

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.

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:

Facilities and Other Resources: Describe available clinical research and laboratory facilities:

• Dietary and pharmacy facilities including location, storage, and security systems.
• Clinic facilities including, layout, storage, security and backup systems.
• Facilities for collection and processing of human biologic specimens (e.g., peripheral blood, stool), and for biologic assays that require fresh cells (e.g., basophil activation assays).
• Any specialized capabilities available in the clinical, dietary, pharmacy, or laboratory location(s) with examples of recent, successful use.
• In addition, describe resources available for recruitment of the patient populations required to conduct Food Allergy clinical studies.

Other Attachments: Provide the following additional materials specified below in support of the application.

Provide a PDF file with the name Staffing Plan . This should consist of two sections: Staffing Plan: Administration and Operations and Staffing Plan: Clinical Trial . The Administration and Operations section should contain the proposed staffing plan for staff start up activities required prior to clinical trial implementation. The Clinical Trial section should contain the staffing plan for all clinical trial activities associated with the clinical trial proposed within this application. Indicate the qualifications and expertise in the field of food allergy research that will be required for each position. Positions may include: clinical staff (nurses and coordinators), dietary/nutrition services staff; pharmacy services staff; other support services, such as social workers or psychology staff; and laboratory technicians for biologic sample processing. Do not name individuals.

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

Biosketches for PD(s)/PI(s) should reflect the following information: Overall scientific experience and participation in clinical research, as well as experience in food allergy research and clinical trial design including double-blind, placebo-controlled oral food challenges and with allergen immunotherapy for food allergy, and experience as part of multi-center collaborative research (if applicable include name of each study, ClinicalTrials.gov registration number, funding source; site where the study was conducted, and type and name of intervention). Provide evidence of the PD(s)/PI(s) experience with the procedures and the population of the proposed study.

Include the Biosketch of at least one New or Early Stage investigator who will be involved in the functions of the CoFAR CRU and provide background information (relevant training and research experience).

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

Applicants must include funding in the budget for the following:

• Administration and Operations. Include costs for the staff required for startup activities prior to clinical trial implementation as designated in the Staffing Plan: Administration and Operations and the maintenance of a food allergic patient database.
• Clinical Trial. Request the budget for your site's portion of the proposed multi-center clinical trial including the following:
  • Salary for additional staff or expanded commitment of core staff
  • Protocol specific participant screening and recruitment
  • Patient retention
  • Protocol required tests and evaluations
  • Participant reimbursement
  • Equipment and supplies necessary to conduct the clinical trials and clinical studies
  • Cost of intervention for clinical trials, if applicable.
• Travel expenses for senior and key personnel (up to 3 people in total) to travel to attend 2 CoFAR Program meetings per year in the Rockville, Maryland area to discuss Program Reviews, conduct Strategic Planning Activities, and to stimulate CoFAR LC and CoFAR CRU interactions and communications.

DO NOT request support for the following services since they are provided to the CoFAR CRUs through other sources:

• Protocol Funds for other CRUs participating in the proposed multi-center project
• Support for services provided by the NIAID-DAIT Statistical and Clinical Coordinating Center. These include: 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 for services provided by NIAID for public access, either through ImmPort or through another NIAID resource.
• Support for IND related expenses.
• Support for DSMB.

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 overall Specific Aims of the CoFAR Clinical Research Units (Administration and Operations and the Clinical Trial).

Research Strategy: The Research Strategy must consist of the following clearly labeled sections uploaded as a single attachment. Discuss strategy and resources for establishing and maintaining a CRU as directed for each subsection. Do not include any preliminary data from ancillary studies or animal models research.

Administration and Operations

A. Planning and Coordination

• Describe how through the Planning and Coordination section, the CRU will be available to work with the CoFAR LC to implement approved clinical trials and studies. The description should include plans for communications with and interaction with CoFAR entities (CoFAR LC and SACCC) and how clinical trials and studies will be implemented.
• Include a plan to provide timely status updates, including financial information to the NIAID and CoFAR LC.
• Include plans to update policies and procedures for study management and continuous oversight to ensure timely and accurate data collection, and policies and procedures to ensure the safe and ethical conduct of clinical research in accordance to Federal regulatory requirements, cGCP and ICH guidelines.
• Discuss institutional policies on the use of federated IRB models, which are likely to be used for the CoFAR.
• Include a plan for mentoring New and Early Stage Investigators in clinical research careers and a plan for nurturing New and Early Stage Investigators during the period of the CoFAR CRU award.
• Discuss how the knowledge and experience of the CRU PD(s)/PI(s) can enhance the CoFAR Steering Committee and other CoFAR research activities.
• Provide a brief plan for leadership succession if the PD/PI is, for any reason, unable to continue as the leader of the program.
• Discuss plans for interactions and collaborations including how information will be shared and updated with other CoFAR entities including the CoFAR LC and the SACCC.

B. Research Operations

1. Clinical Research Unit Functions:

• Describe plans for training CoFAR CRU personnel; indicate how members of the team are trained in clinical research including how training content is developed/decided, reviewed, evaluated, and modified and how it ensures in-depth knowledge of cGCP, Federal regulatory requirements, and ICH guidelines.
• Discuss the challenges and opportunities that the team may encounter when conducting clinical studies for food allergy prevention and treatment. Emphasize unique strengths the CRU can offer to the CoFAR collaborative effort (e.g., particular capabilities in an area of food allergy, team leadership, and training, or protocol adherence strategies).
• Discuss the team’s capacity and commitment to increase staff availability as CoFAR clinical projects are implemented and discuss adaptations that might be implemented for different types of clinical projects.
• Discuss current participation in other food allergy research groups or networks that might complement participation in CoFAR.

2. Patient Recruitment for CoFAR studies:

• Describe plans and procedures for recruitment, screening and subject retention for the CoFAR clinical trials and studies. Include plans for the establishment and maintenance of a food-allergic patient database. For birth cohort studies, describe resources and approaches to recruit prospective parent(s) whose infants will be at risk of food allergy. Include a discussion of innovative strategies to be used by the CRUs to recruit and retain diverse populations necessary for studies that have the potential for significant impact to the field. Justify the proposed approaches.
• Indicate the size of the food allergy population seen at the CRU institution; present by age groups, ethnicity and gender, food allergy severity and co-morbidities.
• Describe other ongoing food allergy research projects in the community and how competition for patient recruitment with these trials will be managed.
• Provide evidence for links with other health care provider groups, such as primary care or general pediatrics. If links with other groups are anticipated, the application should include a plan describing how the applicant CRU will identify those affiliates most likely to be productive, and link to and operate with them.
• Describe and discuss approaches to improve incorporation of other difficult-to-enroll groups such as minorities, adults and infants with food allergy.
• Discuss the team’s plans for outreach to minority groups affected by food allergy and provide innovative plans for reaching out to under-served areas
• Discuss outreach activities to the food allergy community and patient organizations.
• Discuss the prospects to achieve patient recruitment targets using approximate numbers of study participants, based on the previous CoFAR studies, as presented in Section I and the following information:
• The CoFAR CRUs should be able to support a level of clinical research where all 3 clinical projects are conducted simultaneously. This could result in up to a total of 120 study participants being simultaneously followed at each CRU during any given award year.
• Discuss the use of specific food allergy diagnostic procedures, (e.g. double-blind, placebo-controlled oral food challenges); and food allergy treatment, including allergen immunotherapy, by the CRU.

Clinical Trial

Describe one cutting edge multi-center clinical trial on IgE-mediated food allergy. Discuss the clinical and biological significance of the proposed trial for the field of food allergy focusing on immune-based approaches such as preventative early allergen exposure, new forms of allergen immunotherapy including immunotherapy in combination with adjuvants, anti-cytokine treatment, or other immunomodulatory agents/approaches. Include preliminary and supporting data as appropriate. Do not propose mechanistic studies as these will be solicited and awarded through the CoFAR Opportunity Fund. Do not submit a detailed, final clinical protocol; following an award, final clinical protocols will be developed collaboratively.

For the proposed clinical trial

• Discuss the rationale for the study, the significance of the problem being studied and the potential impact of the proposed work. Indicate how the trial will improve the clinical outcome of patients with food allergy.
• Describe earlier studies that led to the proposed clinical trial and provide information or data from preliminary studies which address the need for and the feasibility of the project.
• Concisely describe the design of the proposed trial (include rationale for pivotal choices):
  • Hypothesis;
  • Study objectives (primary, secondary);
  • Primary and secondary clinical outcomes;
  • Study population with eligibility criteria;
  • Study visit schedule and primary evaluations, including laboratory evaluations;
  • Study duration and study timeline;
  • Key features of a safety monitoring plan including potential risks and measures to mitigate risks. Describe known toxicities of the investigational intervention(s), as well as any concerns for known or potential toxicities unique to the study population;
  • Summary of the statistical analysis plan and of sample size calculations with description of statistical power. Note that the participation of a SACCC in the functions of the CoFAR does not negate the need for a comprehensive statistical analysis plan in this application.
• Provide a feasibility assessment:
  • 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;
  • Discuss anticipated problems and propose approaches to overcome or minimize such problems including problems in subject recruitment, enrollment and retention;
  • 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)
  • Estimate the total cost of the trial including anticipated costs for the entire number of CRUs needed to complete the proposed trial. Do not include in this estimate the services that will be provided by the SACCC.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

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

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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). 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) 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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) Application Guide.

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

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

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.

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 Administration and Operations Element and the Clinical Trial Element within each application will also each receive a separate impact score.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

Administration and Operations

As designed, is the proposed CRU poised to address the significant challenges CoFAR will face in pursuing a broad range of food allergy therapies, including the ability to involve a diverse population of patients with food allergy?

Clinical Trial

Does the proposed trial address a significant problem in food allergy treatment or prevention?

If a treatment trial is proposed, does it have the potential to lead to substantial improvement in the lives of people living with food allergy?

Does the proposed clinical trial have a high likelihood of success in achieving significant advances in the area of food allergy research?

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?

Administration and Operations

Do the PD(s)/PI(s) have the expertise and research experience in food allergy and clinical trial design, including double-blind, placebo controlled food challenges and administration of allergen immunotherapy, in order to phenotype and characterize patients, and execute all other functions of the CoFAR?

Do the PD(s)/PI(s) have a track record of working collaboratively in large multi-center clinical trials or studies?

Clinical Trial

Do the PD(s)/PI(s) have expertise in food allergy clinical trial design that will be valuable in developing and prioritizing CoFAR activities?

Do the staff members required for supporting the functions of the CoFAR clinical projects have appropriate and adequate qualifications, training and expertise in the field of food allergy research? Do the new or early stage investigator(s) identified in the application have adequate training and commitment for development as clinical researchers in the field of food allergy?

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?

Administration and Operations

Does the applicant propose innovative approaches to reach, recruit and retain a diverse and representative populations of patients with food allergy necessary for CoFAR to have a significant impact for the community of patients with food allergy?

Clinical Trial

Does the trial design incorporate a cutting-edge approach (es) to food allergy therapy or prevention?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed? Are there appropriate plans for recruitment of populations that are difficult to recruit, such as minorities and adults with food allergy?

Administration and Operations

Has the CRU demonstrated the capability to screen and recruit individuals including infants at high risk of food allergy for potential trials of preventive therapies in food allergy.

Has the CRU demonstrated the ability to involve a diverse population of patients with food allergy that represents the entire spectrum of affected individuals in terms of race, age, gender and specific food allergies?

Does the application describe a cohesive structure and range of support services to support food allergy clinical trials and/or studies under CoFAR?

Are obstacles for subject recruitment, including competing clinical projects underway in the community, adequately addressed?

Does the applicant present sufficient plans for interacting with other CoFAR entities (CoFAR LC, OF awardees, and SACCC) to ensure implementation of clinical studies (both trials and observational studies)?

Does the applicant provide adequate plans for providing timely updates to NIAID, the CoFAR LC and the SACCC?

Does the CRU offer unique strengths to the CoFAR collaborative effort?

Clinical Trial

Is there a clear question(s) that the clinical trial will and can address?

Is the clinical trial adequately justified and supported by preliminary data or previously published research?

Is the experimental design of the clinical trial appropriate in terms of primary and secondary outcomes, study population and eligibility criteria, study arms (appropriate controls), study visit schedule and primary evaluations, study duration and study timeline?

Are known toxicities of the investigational interventions, as well as any concerns for known or potential toxicities unique to the study population, described?

Is the safety monitoring plan, including potential risks and measures to mitigate risks, appropriately described?

Is the summary of the statistical analysis plan and of sample size calculations with description of statistical power adequate and is sample size justifiable?

Is the potential influence on the proposed clinical trial of other interventions with similar mechanism of action adequately considered?

Does the application discuss anticipated problems and propose approaches to overcome or minimize such problems?

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

If applicable, is there evidence of commitment by a manufacturer to provide an investigational drug?

Are the clinical tools and laboratory tests required for patient characterization adequately described and justified?

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?

Administration and Operations

Does the CRU, as a site, have the ability and capability to administer and perform multi-site food allergy clinical trials and observational clinical studies?

Are there adequate, available and appropriate clinical facilities and ancillary facilities to provide the clinical care required to support the CoFAR CRU?

Is there evidence demonstrating strong past institutional performance in food allergy research?

Is there evidence of participation in large, multi-center clinical trials?

Are there adequate, available and appropriate clinical facilities and ancillary facilities to provide the clinical care required to support the CoFAR CRUs?

Does the site have a sufficiently large and diverse population of patients with food allergy to draw on for clinical trial recruitment?

Clinical Trial

Does the application describe a cohesive structure and range of support services to support food allergy trials and/or research under CoFAR?

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.

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.

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.

Not Applicable

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.

Not Applicable

Not Applicable

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.

Not Applicable

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).

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

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

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

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

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.

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

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

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

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

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 75 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(s)/PI(s) will provide for the overall management of the CoFAR Clinical Research Unit (CRU) and coordination of activities related to execution of the clinical protocols assigned by the CoFAR LC. The PD/PI will work within the CRU structure and CRU staff to carry out the following functions:

• Establish and codify the clinical protocols assigned by the CoFAR LC.
• Develop, implement and manage a process for allocating CRU resources and fully manage appropriate resources to conduct the clinical projects assigned to the CRU.
• Establish an organizational structure that allows for efficient coordination and rapid communication with multiple entities participating in the CoFAR, including NIAID, NIAID-sponsored and funded entities such as the SACCC, and the CoFAR LC.
• Establish a plan that will ensure that all IRB primary reviews of any multi-center trial or study are conducted within the timeframe negotiated by the NIAID Project Scientist preferably using a federated IRB model.
• Serve as a voting member of the CoFAR Investigator Committee and the CoFAR Steering Committee.
• Participate in CoFAR LC sponsored training activities, including protocol specific training with all protocol-involved staff.

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

• NIAID will assign two Project Scientists to CoFAR. Project Scientists will provide guidance and support in the design of clinical projects and related research activities, will serve as a resource for protocol design and development, will provide scientific/programmatic support during the conduct 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. The role of NIAID Project Scientists will be to facilitate and not direct activities. It is anticipated that decisions in all activities will be reached by consensus and that the NIAID Project Scientists will participate in this process. In various matters related to clinical study approval and oversight, NIAID Project Scientists will have final decision authority, as described below.
• Protocol Development, Review and Approval: NIAID Project Scientists and other NIAID staff will participate in the development, review, and approval of all CoFAR clinical project protocols. All clinical trials and clinical study protocols, as well as the mechanistic study protocols that will be supported by the CoFAR Opportunity Fund administered through the CoFAR LC, will be reviewed by NIAID and, depending on their level of complexity and risk, will be further reviewed by the DAIT/NIAID CRC and by the DAIT/NIAID Asthma and Allergy Data and Safety Monitoring Board (DSMB) or another monitoring body. Prior to study initiation, all clinical study protocols must be approved by an assigned NIAID Project Scientist who will be the Medical Monitor of the study, as well as by an assigned NIAID Regulatory Officer.
• IND/IDE: NIAID will serve as the IND/IDE sponsor for all CoFAR clinical trials requiring an IND/IDE. As part of NIAID’s IND/IDE sponsor responsibilities, a NIAID Medical Monitor will obtain, through the SACCC, 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 Statistical and Clinical Coordinating Center (SACCC), will prepare and submit the final study reports to the FDA. Under certain circumstances, this role may be delegated by NIAID to another entity (e.g., a collaborating pharmaceutical company).
• Clinical Trial Monitoring: NIAID will be responsible for monitoring compliance with good clinical practices, regulatory compliance, accurate protocol implementation, internal quality assurance, and test agent accountability at the CoFAR CRUs. NIAID will convene an independent NIAID Data and Safety Monitoring Board (DSMB) or another monitoring body to review and monitor any protocols deemed to possess more than minimal risks. At NIAID s discretion, the NIAID Medical Monitor may request that the monitoring body convenes ad hoc to review a serious adverse event or a cluster of adverse events or serious adverse events. Furthermore, the NIAID Medical Monitor may request that the SACCC conduct for cause monitoring visits to a CRU. Depending on the seriousness of the problem, such visits may be conducted by the NIAID Medical Monitor and/or NIAID staff. 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 for any of the following reasons: (1) risk to subject safety; (2) the scientific question is no longer relevant or the objectives will not be met; (3) failure to comply with Good Clinical Practices, federal regulations, or Terms and Conditions of Award; (4) occurrence of unforeseen drug safety issues or emergence of data from preclinical studies indicating the presence of unanticipated toxicity; (5) risks that cannot be adequately quantified; (6) failure to remedy deficiencies identified through site monitoring; (7) substandard data; (8) inadequate progress in fulfilling the research agenda; (9) slow accrual; or (10) reaching a major study endpoint substantially before schedule and with persuasive statistical significance.
• Scientific and Programmatic Oversight: An NIAID program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This stewardship includes monitoring program progress, approving changes and concurring with proceeding into study implementation stage. Release of each yearly funding increment for a CoFAR CRU will be based on a review of progress. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of a CoFAR program or any CoFAR 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.
• NIAID will establish an External Scientific Advisory Group (ESAG) composed of clinical and basic science investigators. Members of the ESAG will review and offer input on CoFAR clinical projects and mechanistic studies, both during protocol development and during the analysis of results. ESAG members may be invited to attend CoFAR Steering Committee meetings. The ESAG will submit its recommendations to the NIAID Project Scientists, who will then inform the CoFAR CRU PD/PI. Recommendations by the ESAG are advisory.

Areas of Joint Responsibility include:

• Research Plans. Implementing, monitoring, and updating the clinical research plan for CoFAR to ensure consistency and relevance with the NIAID scientific priorities.
• Research Activities. Reviewing the CoFAR CRU’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 Investigator Committee. The purpose of this committee is to review progress of all projects. This committee will be composed of the PD(s)/PI(s) of the CoFAR LC, the leader of the Central Biomarker Facility component of the CoFAR LC, the designated Project Leader of the SACCC, the PD/PI of all CRUs, the investigators of protocol-specific mechanistic studies and the NIAID staff assigned to each CoFAR clinical project.
• CoFAR Steering Committee. The purpose of this committee is to advise the CoFAR LC PD/PI on which clinical projects the consortium will conduct, approve the final clinical trial and study protocols and modify or add protocols as scientifically indicated. . The overall scientific plan of CoFAR 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 Consortium sponsored studies to the scientific and lay communities and other relevant audiences. The CoFAR Steering Committee will include the PD/PI of the CoFAR LC (who will also be the Chairperson), two other members of the LC to be chosen by the CoFAR LC PD/PI, a PD/PI from each of the CoFAR CRUs, the designated Project Leader of the SACCC, and 2 NIAID Project Scientists. All members of the Steering Committee are voting members with the exception of the NIAID Project Scientists.
• Clinical Study Implementation and Management. The PD/PI of a CoFAR CRU will work in coordination with the SACCC, through NIAID, to execute the following tasks related to clinical study implementation and management.
  • 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 in compliance with NIH guidelines and Federal regulations, requirements and policies. This will include compliance with clinical site and study monitoring functions carried out by the SACCC for: (i) site initiation visits, when deemed necessary; (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 will also include CRU PD/PI 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 to ensure the safe and ethical conduct of clinical research in accordance to Federal regulatory requirements, GCP and ICH guidelines and study-specific DSMPs, including the recording and reporting of all Adverse Events (AEs) and Serious Adverse Events (SAEs). This will include policies for the preparation and submission of AE and SAE Reports to the SACCC for initial review and assessment, followed by final assessment and classification by the NIAID-designated Medical Monitor.

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

• Access to Data. The NIAID Project Scientists, the NIAID program official or designees will have access to all data generated under this cooperative agreement, and may review the data as recorded on the case report forms or in a database. Data must be available for external checking against the original source documentation. All clinical trial, clinical study, biomarker and mechanistic data produced by CoFAR will be made publicly available by NIAID, at the time of publication of the primary outcome of the study or 18 months after database lock, whichever comes first. 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. All final manuscripts must be submitted to the NIAID for review in advance of journal submission.

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 CoFAR Steering Committee, 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.

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

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

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

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

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Michael Minnicozzi, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3532
Email: [email protected]

Louis Rosenthal, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5070
Email: [email protected]

Jorge Machuca
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2981
Email: [email protected]

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.