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

NIAID Division of Allergy, Immunology and Transplantation: Statistical and Clinical Coordinating Center (UM2)

Activity Code

UM2 Program Project or Center with Complex Structure Cooperative Agreement

Announcement Type

New

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-14-016

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855; 93.856 

Funding Opportunity Purpose

The purpose of this FOA is to solicit applications for the Statistical and Clinical Coordinating Center, NIAID Division of Allergy, Immunology and Transplantation.  The awardee will provide a broad range of support critical for the design, development, implementation, monitoring and analysis of clinical research carried out by multiple Division-supported programs in three disease areas: asthma and allergic diseases, autoimmune diseases, and transplantation.  The scope of support to be provided includes statistical design and analysis, protocol development, study initiation and management, data management, clinical site monitoring, safety monitoring, and final analysis of study findings.  The types of research for which support will be provided include clinical trials, integrated studies of underlying mechanisms, clinical studies (e.g., longitudinal studies, genetic studies, etc.), and studies to identify and validate surrogates/biomarkers.

Key Dates
Posted Date

March 26, 2014

Open Date (Earliest Submission Date)

June 18, 2014

Letter of Intent Due Date(s)

June 18, 2014

Application Due Date(s)

July 18, 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

November 2014

Advisory Council Review

January 2015

Earliest Start Date

April 2015

Expiration Date

July 19, 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.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
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

The purpose of this FOA is to solicit applications for the Statistical and Clinical Coordinating Center (SACCC - hereinafter referred to as ‘Center’ for the purposes of this FOA), NIAID Division of Allergy, Immunology and Transplantation (DAIT).  The objective of the Center is to provide a broad range of support critical for the design, development, execution, monitoring, and analysis of clinical research sponsored by the Division in three disease areas:  asthma and allergic diseases; autoimmune diseases; and transplantation of cells, tissues and solid organs.  The scope of clinical research to be supported by the Center includes:  (i) clinical trials at all phases to evaluate the safety and efficacy of investigational products and innovative approaches for disease treatment and prevention; (ii) studies of underlying mechanisms as integral components of clinical trials; (iii) clinical studies (e.g., longitudinal birth cohort studies, genetic studies, etc.); and (iv) surrogate/biomarker studies.  The scope of statistical and clinical coordination functions to be performed by the Center includes:  statistical design and analysis; protocol development; study initiation and management; clinical site monitoring; data management; and safety oversight and reporting.

Background

Research supported and conducted by the NIAID, National Institutes of Health (NIH) strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases.  The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research through a variety of research grants and contracts that focuses on immune-mediated diseases.  A critical component of the Division’s mission focuses on clinical research to develop new and/or improved therapies and prevention strategies through rigorous evaluations of the safety and efficacy of investigational products and approaches, studies to elucidate underlying mechanisms, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of natural history, genetics, etc.

Major research programs are supported in three disease areas: asthma and allergic diseases; autoimmune diseases; and transplantation.  Responsibility for these clinical research programs rests with multiple DAIT organizational components: the Asthma, Allergy and Airway Biology Branch; the Autoimmunity and Mucosal Immunology Branch; the Transplantation Branch; and the Clinical Research Operations Program.

In order to provide for critical clinical research support, DAIT has established multiple Statistical and Clinical Coordinating Centers (SACCCs) dedicated to specific research programs.  Through this FOA, DAIT intends to consolidate such support under a single multi-component cooperative agreement. 

Objectives and Scope of DAIT-supported Clinical Research Programs

The DAIT-supported clinical research programs to be supported by the Center include, but are not limited to, those described below under each of the three disease areas. 

One DAIT-supported clinical research program, the Collaborative Network for Clinical Research on Immune Tolerance (hereinafter referred to as “ITN” for Immune Tolerance Network), focuses on mechanisms underlying the induction, maintenance and loss of immune tolerance in humans, with clinical research conducted in all three disease areas.  This Network consists of an international consortium of clinical and basic scientists in the U.S., Canada, Mexico, Europe, and Australia dedicated to the clinical evaluation of novel, tolerance-inducing therapies in asthma and allergic diseases, autoimmune diseases, and transplantation.  The research carried out by this Network encompasses clinical trials at all phases to evaluate investigational products and approaches for the induction and maintenance of immune tolerance, mechanistic studies and the development of tolerance assays as integral components of the clinical trials undertaken.  Information about the Network’s clinical research is included under each of the three disease areas below.  More information about this research program is located at www.immunetolerance.org .

Asthma and Allergic Diseases Clinical Research Programs

The current ADRN SACCC maintains a registry of AD subjects and controls with patient-specific information and results from laboratory tests. More information about this research program is available at http://www.nationaljewish.org/adrn/index/sites/

The current ICAC SACCC maintains a Clinical Specimen Repository of biological samples from all Consortium studies.

Autoimmune Diseases Clinical Research Programs

ACE Basic Research Program investigates autoimmune disease in humans to identify common and distinct mechanisms in disease pathogenesis, e.g., mechanisms of action of existing therapies, biomarkers of disease status, cellular analysis for diagnosis or therapy, etc. 

ACE Clinical Research Program supports single and multi-site clinical trials to evaluate promising strategies and approaches for the treatment and prevention of a broad range of autoimmune diseases, including type 1 diabetes, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease, and scleroderma.  The scope of clinical strategies/approaches includes:  (i) investigational drugs; (ii) combinations of approved drugs; (iii) comparative effectiveness studies using approved drugs; and (iv) re-purposing drugs approved for other indications based on biological mechanisms.  All ACE clinical trials include integrated mechanistic studies designed to enhance understanding of the mechanisms of action of the interventions being evaluated.  Support is also provided for preclinical safety studies in support of clinical trials and for collaborative projects, using samples from previously completed clinical trials, in multiple areas of interest, including but not limited to: (i) pathogenesis of human autoimmune disease; (ii) mechanisms of action of existing therapies; (iii) biomarkers of disease status, including disease progression, prediction of remission or relapse, and therapeutic response; (iv) cellular analyses for diagnosis or therapy; and (v) analyses of genetic variations.  More information about this research program is available at www.autoimmunitycenters.org.

Transplantation Clinical Research Programs

Applicants are advised to refer to http://www.niaid.nih.gov/about/organization/dait/Documents/ClinicalWorkBreakdownSfc.pdf for additional information on DAIT-supported clinical research programs and other clinical research support organizations.

Center Structure

The Center will consist of nine functional entities grouped as follows: 

Leadership Group

One Leadership Group, headed by the Leadership Group Director, will have overall responsibility for planning, directing, coordinating, managing and evaluating Center activities. 

Disease-Specific Groups

Three Disease-Specific Groups, each headed by a Group Leader, will provide services in three functional areas: (i) statistical design and analysis; (ii) protocol development; and (iii) study initiation and management.  The three Disease-Specific Groups are:

Centralized Groups

Five Centralized Groups, each headed by a Group Leader, will provide support for DAIT clinical research programs for all three disease areas.  The five Centralized Groups are:

The awardee will be expected to support the personnel, consultants and other resources necessary for statistical and clinical coordination support for (i) the continuation and completion of ongoing clinical trials, mechanistic studies, and clinical studies, and (ii) new clinical research projects approved for implementation by DAIT.

In addition, statistical and clinical coordination responsibilities will be carried out for all DAIT-supported clinical research programs with some exceptions.  Those exceptions, where applicable, are noted under the descriptions of Center functions below. 

Center Functions, Responsibilities and Duties


Leadership Group (LG):

The LG will be responsible for overall planning, direction, coordination, management and evaluation of the Center’s activities and for the performance of certain technical, operational, administrative and fiscal functions for the project as a whole. 

LG Membership

Members of the LG will include the Disease-Specific Group Leaders as well as NIAID staff representing: (i) each of the three clinical disease areas; (ii) a bioinformatician; (iii) a regulatory officer; and (iv) on an ad hoc basis, a biostatistician.  The awardee may elect to appoint Centralized Group Leaders to serve on the LG on a temporary or permanent basis.

LG Functions

The LG will be responsible for carrying out the functions specified below.  The awardee may elect to establish short- and long-term LG committees focused on specific processes and procedures to guide and manage the Center’s activities.

Disease-Specific Groups:

Structure

Three Disease-Specific Groups – Asthma and Allergic Diseases Group, Autoimmune Diseases Group, and Transplantation Group - will be responsible for providing support in three functional areas:  (i) statistical design and analysis; (ii) protocol development; and (iii) study initiation and management.  Responsibility for overall planning, tracking, managing and coordinating the activities of the Disease-Specific Groups will rest with the Group Leaders.  In addition, these Group Leaders may serve as voting members of the Steering Committees for DAIT-supported clinical research programs or may delegate that role to other senior staff in their Group with NIAID approval.  In addition, each Disease-Specific Group will provide appropriate project management staff for day-to-day operations.  Within each Disease-Specific Group, the awardee may elect to establish additional organizational entities, e.g., sub-groups, teams, etc., to participate in planning, conducting and managing Group activities.  

Disease-Specific Group Functions

All three Disease-Specific Groups will provide support for the following functions common to all three Groups:

Statistical Design and Analysis                         

Statistical Design

Statistical Analysis

Protocol Development

Development of Clinical Protocols and Protocol-Related Documents

In collaboration with investigators and DAIT staff:

Primary responsibility for protocol development for ITN clinical trials and mechanistic studies rests with the Network’s Clinical Trial Group, with this Center providing expert advice and assistance in this area on an as-needed basis.

Study Initiation and Management

Study Initiation and Training of Clinical Site Personnel

Study Management

Manage, coordinate and monitor the implementation and conduct of clinical trials/studies, including:

Asthma and Allergic Diseases Group – Additional Functions

In addition, the Asthma and Allergic Diseases Group will have the following responsibilities and functions:

Atopic Dermatitis Research Network (ADRN) Subject Registry

Inner City Asthma Consortium (ICAC) Clinical Specimen Repository

Centralized Groups:

Clinical Site Monitoring Group (CSMG)

The Clinical Site Monitoring Group (CSMG) will perform the functions delineated below for all DAIT-supported clinical research programs with the exception of clinical site monitoring support for the ITN and AADCRCs, which will be supported through a separate contract.  The Center will be required to collaborate and coordinate with the ITN Clinical Site Monitoring Center contractor with respect to ensuring compliance with Federal regulatory requirements and NIH and NIAID policies and procedures.

Standard Operating Procedures (SOPs)

Site Establishment Visits

Interim Site Monitoring Visits

Additional Site Visits

Site Monitor Training

Data Management and Reporting Group (DMRG)

The Data Management and Reporting Group (DMRG) will perform the following functions for all three disease areas specified in this FOA.

Data Management System – Clinical and Laboratory Study Data

Establish and operate a computer-based system, with appropriate system security and integrity provisions, to create databases for all clinical and laboratory study data providing for multiple features and capabilities, including:

Data Management System – Safety Data

Establish and operate a computer-based system, with appropriate system security and integrity procedures, to monitor, track, archive and report Serious Adverse Events (SAEs) from all clinical sites providing for multiple features and capabilities, including:

Data Quality Control

(i)  Establish a quality control system for all clinical, laboratory and SAE data providing for verification of 100 percent of study data and multiple features and capabilities, including:

(ii)  Prepare and review and revise on an annual basis manuals and procedures documenting data collection, editing and validation standards and procedures.

Training of Clinical Site Personnel

Provide training to clinical site personnel on the design of data collection instruments and procedures for data collection, entry, management, validation, quality control and submission through user manuals and participation in Study Initiation activities.

Data Management System Improvements

Investigate and assess the benefits and applicability of new and improved technologies to enhance the efficiency and ease of use of the two data management systems, and provide written recommendations to DAIT for proposed enhancements and improvements.

Safety Oversight and Reporting Group (SORG)

The Safety Oversight and Reporting Group (SORG) will perform the following functions for all three disease areas specified in this FOA.

Safety Reporting

Establish and operate a Safety Reporting Center for all clinical trials to provide the following:

DAIT Data and Safety Monitoring Boards (DSMBs)

Provide support for certain functions associated with safety monitoring by independent DSMBs/SMCs established by DAIT in each of the three disease areas to review final clinical protocols and interim and final study data to ensure the safety of clinical trial subjects, including:

Ancillary Services Group (ASG)

The Ancillary Services Group (ASG) will perform the following functions for all three disease areas specified in this FOA.

Sample Tracking

Establish and operate one or more computerized database systems for the site- and study-specific tracking and reporting/reconciliation of specimen collection, sample processing, inter-laboratory shipping and receipt, final specimen disposition, and facilitation of data handling for core mechanistic laboratory results, e.g., proteomic array, ELISPOT data.

Provision of Materials for Laboratory Testing

Purchase, package and ship kit materials required for protocol-specific specialized (core/mechanistic) laboratory tests, ensure intact receipt, and maintain a computerized inventory of all materials distributed.

Bioinformatics Group (BG)

The primary role of the Bioinformatics Group (BG) is to foster the long-term capacity for data exchange and utilization for DAIT-supported clinical research programs and the immunological community in general.  Internally, the BG will work with the DMRG and other Center Groups to facilitate data collection and integration, including complex clinical and mechanistic studies from the three disease-specific areas specified in this FOA.  The BG will also be a resource for appropriate data exchange and advice for external investigators and data repositories.  Collectively, the BG should bring together individuals with expertise in biostatistics, systems immunology, data management, programming, and high performance computing.

To facilitate broad and optimal utility of data collected by DAIT-supported clinical research programs, the BG will participate/advise on aspects of experiment planning, building of computational infrastructure, data management and analysis, and collaboration with domain specialists and/or the bioinformatics staff of DAIT-supported clinical research programs, as needed, to address the increasingly complex and “big data” needs.

Specific functions of the BG pertaining to supporting the collection, storage, retrieval, archiving, integration of generated data and computing infrastructure include:

In addition, leveraging on its unique position of interacting and overseeing multiple studies, the BG will support and assist with the utilization of Center information resources and infrastructure for primary and secondary data analyses, including:

Note that mechanistic and clinical data integration from ITN-supported clinical trials is under the purview of the ITN’s Bioinformatics Group.  The BG should include collaboration and coordination with the ITN Bioinformatics Group as part of its functions.

DAIT Clinical Research Support Resources

Regulatory Sponsorship and Support 

It is anticipated that, with rare exceptions, the NIAID will serve as the regulatory sponsor for clinical trials conducted under Investigational New Drug (IND) Applications, Investigational Device Exemptions (IDEs), and Biologic Licensing Agreements (BLAs), with full responsibility for carrying out sponsor regulatory requirements.  In addition, the Center will coordinate and collaborate with DAIT’s Regulatory Management Center (RMC) contractor responsible for providing technical and administrative assistance for a broad range of functions pertaining to regulatory sponsorship, including preparation of regulatory submissions, reports and other materials, communications with Regulatory Health Authorities, implementation of protocol-specific site registration requirements, and maintenance and management of Sponsor Essential Clinical Documents (SECDs).

Clinical Products Center

A separate contract provides support for all DAIT clinical research programs with respect to the receipt, storage, inventory, packaging, quality assurance, distribution and disposal of study products.  The Center will collaborate with this contractor to ensure appropriate management of study products.

Bioinformatics Support Contract (BISC)

BISC provides resources for all DAIT-supported clinical research programs, including resources for data standard and exchange format development, long-term data archive, and public data sharing.  The Center will collaborate with the BISC contractor with respect to the transfer of clinical and mechanistic study data, in accordance with data standard and exchange formats, for long-term archiving and for public data sharing.

ITN Clinical Site Monitoring Support

A separate contract will provide clinical site monitoring support for the ITN and AADCRC and will not be funded under this FOA.

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

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

Funds Available and Anticipated Number of Awards

The NIAID intends to commit $16.5 million in total costs in FY 2015 to fund one award. 

Award Budget

Application budgets are limited to $16.5 million per year in total costs.

Award Project Period

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

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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:

Paul Amstad, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3121, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Zip Code for express couriers: 20817-7616
Telephone: 301-402-7098
Fax: 301-480-2408
Email: pamstad@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

30 pages

Admin Core - In ASSIST select component type ‘Admin Core’ for Leadership Group

12 pages

Complex Component -- In ASSIST select component type ‘Complex Component’ for the Disease-Specific Component Autoimmune Disease Group:

A.  ADG Structure and Staffing

B.  Statistical Design and Analysis for Clinical Research on Autoimmune Diseases

C.  Protocol Development for Clinical Research on Autoimmune Diseases

D.  Study Initiation and Management for Clinical Research on Autoimmune Diseases

A.  6 pages

B. 30 pages

C. 12 pages

D. 12 pages

Complex Component - In ASSIST select component type ‘Complex Component’ for the Disease-Specific Component Transplantation Group:

A.  TG Structure and Staffing

B.  Statistical Design and Analysis for Clinical Research in Transplantation

C.  Protocol Development for Clinical Research in Transplantation

D.  Study Initiation and Management for Clinical Research in Transplantation

A.  6 pages

B. 30 pages

C. 12 pages

D. 12 pages

Complex Component - In ASSIST select component type ‘Complex Component’ for the Disease-Specific Component Asthma and Allergic Diseases Group:

A.  AADG Structure and Staffing

B.  Statistical Design and Analysis for Clinical Research on Asthma and Allergic Diseases

C.  Protocol Development for Clinical Research on Asthma and Allergic Diseases

D.  Study Initiation and Management for Clinical Research on Asthma and Allergic Diseases

E.  Atopic Dermatitis Research Network (ADRN) Subject Registry

F.  Inner City Asthma Consortium (ICAC) Clinical Specimen Repository

A.  6 pages

B. 30 pages

C. 12 pages

D. 12 pages

E.   6 pages

F.   6 pages

Core - In ASSIST select component type ‘Core’ when preparing the following five Centralized Group Components:

  • Clinical Site Monitoring Group
  • Data Management and Reporting Group
  • Safety Oversight and Reporting Group
  • Ancillary Services Group
  • Bioinformatics Group

12 pages

12 pages

12 pages

12 pages

12 pages


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.. Not Applicable to any of the components listed in this FOA.

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/ 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:  Briefly describe the specific aims of the proposed Center.

Research Strategy:  The Overall section of the application should describe proposed plans for the organization and staffing of the Center, how the components of the organization, including key personnel, will interact and ensure efficient cooperation, communication and coordination, and how the proposed organization of Center components will create an integrated entity capable of effectively providing support for DAIT-sponsored clinical trials and clinical studies.

Include the following:

(i)  An overall organizational chart showing the nine required Center Group Components and any additional organizational entities proposed (e.g., sub-groups, committees, etc.), and identifying the names and degrees of the proposed PD(s)/PI(s), the Group Leaders, and Group staff serving in a senior role;

(ii)  A description of overall plans for the governance of the Center, including lines of authority and reporting, decision-making processes, and communication processes within the Center and with DAIT senior officials, research program PDs/PIs, and other DAIT clinical research support organizations, including proposed processes for resolving operational issues and problems.

(iii)  A discussion of the rationale for the proposed mix of expertise and experience represented by the Disease-Specific and Centralized Group Leaders and personnel serving in a senior role with respect to the Center’s scientific, clinical, technical and operational support responsibilities;

(iv)  An overall discussion of considerations of particular relevance and importance for the design, development, initiation, monitoring and analysis of clinical trials and clinical studies for each of the three disease areas, including the applicability of current and new innovative strategies, methodologies and approaches to overcome common problems and difficulties in human subjects research for these diseases;

(v)  A discussion of bioinformatics approaches/methodologies applicable to the analysis of combined mechanistic and clinical data, including new innovative strategies relevant for the three disease areas; and

(vi)  A detailed description of the relevant expertise, experience and accomplishments of the applicant organization in the planning, direction, coordination, management and provision of the full scope of clinical research support provided for in this FOA in all the three disease areas.  Include the following:

Clinical Research Programs/Projects.  A listing of the clinical research programs/projects, both ongoing and completed, for which statistical and clinical coordination support has been provided by the applicant organization over the past five years, including programs/projects sponsored by public and private sector organizations/entities.  For each program/project, provide the following information; (i) the title of the clinical research program/project; (ii) the name of the  research program/project sponsor; (iii) the scope of statistical and clinical coordination support provided; and (iv) the time period of support.

Accomplishments.  A brief summary of the accomplishments of the applicant organization with respect to the provision of statistical and clinical coordination support over the past five years for both completed and ongoing clinical research programs/projects, e.g., number of clinical trials/studies for which statistical design and analysis support has been provided, number of clinical protocols developed, number of clinical trials for which clinical site monitoring has been conducted, number of data management systems established and operated, etc.

Support for Specific Clinical Trials/Studies.  A listing of individual clinical trials, mechanistic studies and clinical studies, both ongoing and completed, for which the applicant organization has provided support over the past five years in the three disease areas within the scope of this FOA.  Display information by specific disease area, i.e., asthma and allergic diseases, autoimmune diseases and transplantation, and provide the following for each clinical trial/study: (i) study title, including clinical trial phase where applicable, and study sponsor and/or IND sponsor; (ii) sample size and number of participating clinical sites and laboratories; (iii) specific support functions performed (e.g., statistical design and analysis, protocol development, clinical site monitoring, data management, etc.); and (iv) for each specific support function performed, the names of all senior personnel proposed for this FOA with primary responsibility for overall direction/management and for the actual performance of the support function.

Multiple PD/PI Leadership Plan: Identify the PD/PI proposed to serve as the Director of the Leadership Group (LG), describe his/her qualifications for carrying out LG responsibilities, and describe the roles and responsibilities of those PDs/PIs not designated to serve as the LG Director.

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:

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.   

Leadership Group (LG) Component

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 (Leadership Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Leadership Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Leadership Group)

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

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

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Leadership Group)

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 (Leadership Group)

Budget (Leadership Group)

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

Budget for staffing of the LG should be included and limited to the activities of this Group.  The Director of the Leadership Group (LG) will be required to commit not less than 3.6 calendar months per year to the project.  Additional support for activities covered in later Group descriptions should be requested for the budgets for those Groups.  Infrastructure support related to LG functions should be included here as well.

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          (Leadership Group)

Specific Aims:   Briefly describe the specific aims of the LG. 

Research Strategy:   

LG Structure and Staffing.  Describe in detail plans for the structure and staffing of the LG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. The use of tables, diagrams, flow charts and organizational charts is strongly recommended.  Include:  (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project of all key LG personnel serving in a senior role; and (ii) descriptions of the responsibilities of all proposed functional entities within the LG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role.

LG Functions.  Provide proposed plans, procedures and processes for the performance of LG functions.  Include: 

(i) project management and tracking systems for overseeing the effective implementation of clinical research support across all clinical research projects and disease areas;

(ii) assessing, allocating and adjusting Center resources across all clinical research projects and disease areas;

(iii) financial management, tracking and reporting systems and processes;

(iv) information system(s) to support day-to-day activities of the project as a whole, as well as study-specific collaboration portals;

(v) metrics, process(es) and schedules for evaluating Center performance, as well as approaches for implementing necessary improvements;

(vi) assisting in the management of Conflict of Interest (COI); and

(vii) technical and administrative support for meetings/teleconferences.

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:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this component.

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  (Leadership Group)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Leadership Group)

Not Applicable

Autoimmune Diseases Group (ADG) Component

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

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

SF424 (R&R) Cover (Autoimmune Diseases Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Autoimmune Diseases Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Autoimmune Diseases Group)

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

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

Project Narrative:  Do not complete.  Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Autoimmune Diseases Group)

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 (Autoimmune Diseases Group)

Budget (Autoimmune Diseases Group)

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

At the time of the publication of this FOA, the autoimmune disease portfolio is comprised of 32 clinical trials and studies, of which 30 are interventional (23 under IND) and 2 are observational.  Further information about the details of these studies is available at http://www.niaid.nih.gov/about/organization/dait/Documents/ClinicalWorkBreakdownSfc.pdf.  Information about related manuscripts and reports can also be found at that site. 

Clinical study summary:

The interventional trials range in size from 10 to 200 subjects, but average around 100.  The duration of individual participation ranges from approximately 12 weeks to 5 years, with an average of 12 months.  As for the number of sites, the average is 11, but ranges from 1 to 26.  All interventional trials include mechanistic studies requiring collection of immunologic data. 

The applicant should assume the following during the period of the award:

Budget for staffing related to the activities of the ADG should be included here as well as travel ADG leadership and administrative staff needed to support the activities of Network meetings. The autoimmune diseases group leader will be required to commit not less than 7.2 calendar months per year to the project.  For travel purposes, assume two ACE Steering Committee meetings and 3 ITN related meetings per year. At least two will be in the metropolitan Washington, D.C. region.

If consortium agreements are proposed to conduct Group activities include budget information here.  Budget information for proposed consortium agreements is required.

Note:  Of the four subsections of the ADG, Section C. Protocol Development for Clinical Research on Autoimmune Diseases; and Section D. Study Initiation and Management for Clinical Research on Autoimmune Diseases are less relevant to ITN studies since ITN has additional support for these areas.  ADG participation in study conference calls, meetings, etc. in support of these areas should be budgeted. 

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          (Autoimmune Diseases Group)

Specific Aims:  Briefly describe the specific aims of the ADG.

Research Strategy:  The Research Strategy consists of the following four subsections uploaded as a single pdf: A. ADG Structure and Staffing; B. Statistical Design and Analysis for Clinical Research on Autoimmune Diseases; C. Protocol Development for Clinical Research on Autoimmune Diseases; and D. Study Initiation and Management for Clinical Research on Autoimmune Diseases.

A.  ADG Structure and Staffing.

Describe in detail plans for the structure and staffing of the ADG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. Include:  (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project of all key ADG personnel serving in a senior role; (ii) descriptions of the responsibilities of all proposed functional entities within the ADG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role; (iii) proposed processes for decision-making, for resolving operational issues/problems, and for communication within the ADG, between the ADG and other Center groups, with multiple DAIT Branches and Offices involved in clinical research planning, execution, oversight and reporting, with PDs/PIs and senior investigators of DAIT-supported clinical research programs, and with other DAIT-supported clinical research support organizations; and (iv) proposed processes and procedures to ensure the timely and effective implementation of Group functions across all clinical research programs and projects, track progress, identify and resolve technical and operational issues, and monitor the use and adequacy of allocated resources.

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the proposed structure and staffing of the Group.

B.  Statistical Design and Analysis for Clinical Research on Autoimmune Diseases

(i) Provide in-depth discussions of the following: 

(ii) Provide proposed plans and procedures for performing statistical design and analysis functions for the full scope of clinical research on autoimmune diseases, including:  developing and/or assessing the appropriateness and feasibility of statistical designs for proposed clinical trials/studies; developing and refining study designs and statistical analysis plans for approved clinical trials/studies in collaboration with clinical investigators and senior DAIT officials; conducting interim and final statistical analyses and preparing Interim and Final Statistical Analysis Reports; providing assistance for regulatory requirements/activities associated with the statistical design and analysis of clinical trials conducted under INDs, e.g., written materials and oral presentations; preparing regular statistical reports; preparing materials for and making presentation to DSMBs; and participating in the preparation of scientific manuscripts and reports and reviewing the accuracy and completeness of statistical data and data analyses for abstracts, manuscripts and presentations.

C.  Protocol Development for Clinical Research on Autoimmune Diseases

(i) Provide in-depth discussions of the following: critical aspects and considerations for preparing protocols and protocol-related documents (e.g., CRFs, IBs, Manuals of Operations) for the full scope of clinical research on autoimmune diseases, including clinical, medical, pharmacological/pharmacokinetic, toxicologic, chemistry and manufacturing aspects of protocols; common problems and difficulties encountered in developing these aspects of protocols and protocol-related documents for autoimmune diseases and also for clinical trials/studies involving multiple senior officials of research program sponsors, clinical sites and laboratories, and approaches recommended to overcome and/or reduce identified problems and difficulties.

(ii) Provide proposed plans and procedures for collaborating with clinical investigators and senior DAIT officials to develop, review and revise initial and successive drafts of protocols and protocol-related documents in this disease area, including processes for obtaining and documenting input and deliberating and achieving consensus on appropriate modifications/refinements to produce final documents.

D.  Study Initiation and Management for Clinical Research on Autoimmune Diseases

(i)  Study Initiation and Training of Clinical Site Personnel 

(ii) Study Management 

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:

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. 

Planned Enrollment Report (Autoimmune Diseases Group)

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 (Autoimmune Diseases Group)

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

Transplantation Group (TG) Component

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

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

SF424 (R&R) Cover (Transplantation Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Transplantation Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Transplantation Group)

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

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

Project Narrative:  Do not complete.  Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Transplantation Group)

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 (Transplantation Group)

Budget (Transplantation Group)

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

At the time of the publication of this FOA, the transplantation portfolio is comprised of 34 clinical trials and studies, of which 18 are interventional (13 under IND) and 16 are observational.  Further information about the details of these studies is available at http://www.niaid.nih.gov/about/organization/dait/Documents/ClinicalWorkBreakdownSfc.pdf. Information about related manuscripts and reports can also be found at that site. 

Clinical study status:

The trials vary in size from 12 to 5000 subjects, with most studies under 500 subjects. The duration of individual participation ranges from one to three years.  All trials, whether interventional or observational, include in-depth studies of immunologic mechanisms requiring extensive data and specimen collection.

The applicant should assume the following during the period of the award:

Budget for staffing related to the activities of the TG should be included here as well as travel for TG leadership and administrative staff needed to support the activities of Network meetings. The transplantation group leader will be required to commit not less than 7.2 calendar months per year to the project.  For travel purposes, assume twice annual Network meetings and 3 ITN related meetings per year. At least two will be in the metropolitan Washington, D.C. region.

If consortium agreements are proposed to conduct Group activities include budget information here.  Budget information for proposed consortium agreements is required.

Note:  Of the four subsections of the TG, Section C. Protocol Development for Clinical Research in Transplantation; and Section D. Study Initiation and Management for Clinical Research in Transplantation are less relevant to ITN studies since ITN has additional support for these areas.  TG participation in study conference calls, meetings, etc. in support of these areas should be budgeted. 

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          (Transplantation Group)

Specific Aims:  Briefly describe the specific aims of the TG.

Research Strategy:  The Research Strategy consists of the following four subsections uploaded as a single pdf: A. TG Structure and Staffing; B. Statistical Design and Analysis for Clinical Research in Transplantation; C. Protocol Development for Clinical Research in Transplantation; and D. Study Initiation and Management for Clinical Research in Transplantation.

A.  TG Structure and Staffing.

Describe in detail plans for the structure and staffing of the TG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. Include: (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project of all TG personnel serving in a senior role; (ii) descriptions of the responsibilities of all proposed functional entities within the TG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role; (iii) proposed processes for decision-making, for resolving operational issues/problems, and for communication within the TG, between the TG and other Center groups, with multiple DAIT Branches and Offices involved in clinical research planning, execution, oversight and reporting, with PDs/PIs and senior investigators of DAIT-supported clinical research programs, and with other DAIT-supported clinical research support organizations; and (iv) proposed processes and procedures to ensure the timely and effective implementation of Group functions across all clinical research programs and projects, track progress, identify and resolve technical and operational issues, and monitor the use and adequacy of allocated resources.

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the proposed structure and staffing of the Group.

B.  Statistical Design and Analysis for Clinical Research in Transplantation

(i) Provide in-depth discussions of the following: 

(ii) Provide proposed plans and procedures for performing statistical design and analysis functions for the full scope of clinical research in transplantation, including:  developing and/or assessing the appropriateness and feasibility of statistical designs for proposed clinical trials/studies; developing and refining study designs and statistical analysis plans for approved clinical trials/studies in collaboration with clinical investigators and senior DAIT officials; conducting interim and final statistical analyses and preparing Interim and Final Statistical Analysis Reports; providing assistance for regulatory requirements/activities associated with the statistical design and analysis of clinical trials conducted under INDs, e.g., written materials and oral presentations; preparing regular statistical reports; preparing materials for and making presentation to DSMBs; and participating in the preparation of scientific manuscripts and reports and reviewing the accuracy and completeness of statistical data and data analyses for abstracts, manuscripts and presentations.

C.  Protocol Development for Clinical Research in Transplantation

(i) Provide in-depth discussions of the following:  critical aspects and considerations for preparing protocols and protocol-related documents (e.g., CRFs, IBs, Manuals of Operations) for the full scope of clinical research in transplantation, including clinical, medical, pharmacological/pharmacokinetic, toxicologic, chemistry and manufacturing aspects of protocols; common problems and difficulties encountered in developing these aspects of protocols and protocol-related documents for transplantation and also for clinical trials/studies involving multiple senior officials of research program sponsors, clinical sites and laboratories, and approaches recommended to overcome and/or reduce identified problems and difficulties.

(ii) Provide proposed plans and procedures for collaborating with clinical investigators and senior DAIT officials to develop, review and revise initial and successive drafts of protocols and protocol-related documents in this disease area, including processes for obtaining and documenting input and deliberating and achieving consensus on appropriate modifications/refinements to produce final documents.

D.  Study Initiation and Management for Clinical Research in Transplantation

(i)  Study Initiation and Training of Clinical Site Personnel 

(ii) Study Management 

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:

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. 

Planned Enrollment Report (Transplantation Group)

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 (Transplantation Group)

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

Asthma and Allergic Diseases Group (AADG) Component

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

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

SF424 (R&R) Cover (Asthma and Allergic Diseases Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Asthma and Allergic Diseases Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Asthma and Allergic Diseases Group)

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

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

Project Narrative:  Do not complete.  Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Asthma and Allergic Diseases Group)

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 (Asthma and Allergic Diseases Group)

Budget (Asthma and Allergic Diseases Group)

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

At the time of the publication of this FOA, the AADG portfolio is comprised of 22 clinical trials and studies, of which 12 are interventional (9 under IND) and 10 are observational.  Further information about the details of these studies is available at http://www.niaid.nih.gov/about/organization/dait/Documents/ClinicalWorkBreakdownSfc.pdf. Information about related manuscripts and reports can also be found at that site. 

Clinical study summary:

The interventional trials range in size from 40 – 600 subjects but average around 250 subjects.  The duration of individual participation in interventional trials ranges from 12 weeks to 5 years.  All interventional trials include mechanistic studies requiring collection of immunologic data.  Ten of the studies in the portfolio are observational or mechanistic in nature and, with the exception of 2 longitudinal observational studies that include multiple visits and more intensive evaluations, may only require 1-2 visits and less clinical data collection and oversight.  The size of observational studies ranges from 50 to 800 subjects with an average of around 400. The duration of individual participation in these studies ranges from a single visit to several years (e.g., the URECA birth cohort study of ICAC).

The applicant should assume the following during the period of the award:

The applicant should also assume costs for the existing Inner City Asthma Consortium biologic sample repository of approximately 450,000 samples with 35,000 new samples per year.  Most of these samples require deep-freezing (-80ºC) storage facilities and will remain in storage for approximately 5 years.  For samples stored on-site with various investigators in all 3 AADG Consortia (ICAC, CoFAR, ADRN), the applicant should propose and assume costs for a computerized sample tracking system for approximately 20,000 new samples per year.     

The applicant should budget appropriate costs for the ADRN Subject Registry.  The Registry currently has about 2,000 enrollments and expects to enroll about 200 new participants per year.

Budget for staffing related to the activities of the AADG should be included here as well as travel for AADG leadership and administrative staff needed to support the activities of Network meetings. The asthma and allergic diseases group leader will be required to commit not less than 7.2 calendar months per year to the project.  For travel purposes, assume 9 Network meetings and 3 ITN related meetings per year. At least two will be in the metropolitan Washington, D.C. region.

If consortium agreements are proposed to conduct Group activities include budget information here.  Budget information for proposed consortium agreements is required.

Note:  Of the six subsections of the AADG, Section C. Protocol Development for Clinical Research in Asthma and Allergic Diseases; and Section D. Study Initiation and Management for Clinical Research in Asthma and Allergic Diseases are less relevant to ITN studies since ITN has additional support for these areas.  AADG participation in study conference calls, meetings, etc. in support of these areas should be budgeted. 

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          (Asthma and Allergic Diseases Group)

Specific Aims:  Briefly describe the specific aims of the AADG.

Research Strategy:  The Research Strategy consists of the following six subsections uploaded as a single pdf: A. AADG Structure and Staffing; B. Statistical Design and Analysis for Clinical Research on Asthma and Allergic Diseases; C. Protocol Development for Clinical Research on Asthma and Allergic Diseases; D. Study Initiation and Management for Clinical Research on Asthma and Allergic Diseases; E. Atopic Dermatitis Research Network Subject Registry; and F. Inner City Asthma Consortium Clinical Specimen Repository.

A.  AADG Structure and Staffing

Describe in detail plans for the structure and staffing of the AADG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. Include:  (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project for of all key AADG personnel serving in a senior role; (ii) descriptions of the responsibilities of all proposed functional entities within the AADG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role; (iii) proposed processes for decision-making, for resolving operational issues/problems, and for communication within the AADG, between the AADG and other Center groups, with multiple DAIT Branches and Offices involved in clinical research planning, execution, oversight and reporting, with PDs/PIs and senior investigators of DAIT-supported clinical research programs, and with other DAIT-supported clinical research support organizations; and (iv) proposed processes and procedures to ensure the timely and effective implementation of Group functions across all clinical research programs and projects, track progress, identify and resolve technical and operational issues, and monitor the use and adequacy of allocated resources.

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the proposed structure and staffing of the Group.

B.  Statistical Design and Analysis for Clinical Research on Asthma and Allergic Diseases

(i) Provide in-depth discussions of the following: 

(ii) Provide proposed plans and procedures for performing statistical design and analysis functions for the full scope of clinical research on asthma and allergic diseases, including: developing and/or assessing the appropriateness and feasibility of statistical designs for proposed clinical trials/studies; developing and refining study designs and statistical analysis plans for approved clinical trials/studies in collaboration with clinical investigators and senior DAIT officials; conducting interim and final statistical analyses and preparing Interim and Final Statistical Analysis Reports; providing assistance for regulatory requirements/activities associated with the statistical design and analysis of clinical trials conducted under INDs, e.g., written materials and oral presentations; preparing regular statistical reports; preparing materials for and making presentation to DSMBs; and participating in the preparation of scientific manuscripts and reports and reviewing the accuracy and completeness of statistical data and data analyses for abstracts, manuscripts and presentations.

C.  Protocol Development for Clinical Research on Asthma and Allergic Diseases

(i) Provide in-depth discussions of the following:  critical aspects and considerations for preparing protocols and protocol-related documents (e.g., CRFs, IBs, Manuals of Operations) for the full scope of clinical research on asthma and allergic diseases, including clinical, medical, pharmacological/pharmacokinetic, toxicologic, chemistry and manufacturing aspects of protocols; common problems and difficulties encountered in developing these aspects of protocols and protocol-related documents for asthma and allergic diseases and also for clinical trials/studies involving multiple senior officials of research program sponsors, clinical sites and laboratories, and approaches recommended to overcome and/or reduce identified problems and difficulties.

(ii) Provide proposed plans and procedures for collaborating with clinical investigators and senior DAIT officials to develop, review and revise initial and successive drafts of protocols and protocol-related documents in this disease area, including processes for obtaining and documenting input and deliberating and achieving consensus on appropriate modifications/refinements to produce final documents.

D.  Study Initiation and Management for Clinical Research on Asthma and Allergic Diseases

(i)  Study Initiation and Training of Clinical Site Personnel 

(ii) Study Management 

E.  Atopic Dermatitis Research Network (ADRN) Subject Registry

(i) ADRN Subject Registry Structure and Staffing.  Describe plans for the structure and staffing of the ADRN Subject Registry.  Include descriptions of the responsibilities of all proposed functional entities within the Subject Registry; and delineation of lines of authority and reporting. 

(ii) ADRN Subject Registry Functions.  Describe the computerized database management system proposed for the collection, storage, tracking, updating, management, quality control and reporting of data on subjects enrolled in ADRN clinical research.  Include key system capabilities, e.g., system security; secure, password-protected “read” access for designated DAIT staff and ADRN investigators; integrity and compatibility, remote data entry and transmission of clinical specimen data, customizable report generation, etc.  Describe proposed quality assurance/quality control procedures to ensure the accuracy and completeness of subject data, provide brief descriptions of proposed SOPs and instructions on system use, and provide plans for training of clinical site personnel.

F.  Inner City Asthma Consortium (ICAC) Clinical Specimen Repository

(i) ICAC Clinical Specimen Repository Structure and Staffing.  Describe plans for the structure and staffing of the ICAC Clinical Specimen Repository.  Include descriptions of the responsibilities of all proposed functional entities within the repository; and delineation of lines of authority and reporting.

(ii) ICAC Clinical Specimen Repository Functions.  Describe the proposed computerized database management system(s), including key features and capabilities, e.g., remote data entry and transmission for designated DAIT staff and clinical site investigators, provisions for appropriate labeling, storage, handling and disposal of sensitive or controlled data, and customizable report generation, etc.   Describe proposed quality assurance/quality control procedures.  Provide:  a listing, with brief descriptions, of proposed SOPs; the Table of Contents for an example of instructions on system use developed for clinical site personnel; and proposed plans and methods for training clinical site personnel.

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:

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. 

Planned Enrollment Report (Asthma and Allergic Diseases Group)

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 (Asthma and Allergic Diseases Group)

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

Clinical Site Monitoring Group (CSMG) Component

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

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

SF424 (R&R) Cover (Clinical Site Monitoring Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Clinical Site Monitoring Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Site Monitoring Group)

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

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

Project Narrative:  Do not complete.  Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Clinical Site Monitoring Group)

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 Site Monitoring Group)

Budget (Clinical Site Monitoring Group)

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

Budget for the staffing and travel associated with site monitoring activities should be included here. The Clinical Site Monitoring Group Leader will be required to commit not less than 2.4 months per year to the project. 

On average, the total number of site visits per year conducted in support of DAIT studies by research area are:

Further information about these site visits is available at http://www.niaid.nih.gov/about/organization/dait/Documents/ClinicalWorkBreakdownSfc.pdf.

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 Site Monitoring Group)

Specific Aims:  Briefly describe the specific aims of the CSMG.

Research Strategy:

CSMG Structure and Staffing: 

Describe in detail plans for the structure and staffing of the CSMG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. Include:  (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project of all key CSMG personnel serving in a senior role; (ii) descriptions of the responsibilities of all proposed functional entities within the CSMG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role; (iii) proposed processes for decision-making, for resolving operational issues/problems, and for communication within the CSMG, between the CSMG and other Center groups, with multiple DAIT Branches and Offices involved in clinical research planning, execution, oversight and reporting, with PDs/PIs and senior investigators of DAIT-supported clinical research programs, and with other DAIT-supported clinical research support organizations; and (iv) proposed processes and procedures to ensure the timely and effective implementation of Group functions across all clinical research programs and projects, track progress, identify and resolve technical and operational issues, and monitor the use and adequacy of allocated resources.

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the proposed structure and staffing of the Group.

CSMG Functions:

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:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this component.

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 Site Monitoring Group)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Clinical Site Monitoring Group)

Not Applicable

Data Management and Reporting Group (DMRG) Component

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

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

SF424 (R&R) Cover (Data Management and Reporting Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Data Management and Reporting Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management and Reporting Group)

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

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

Project Narrative:  Do not complete.  Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Data Management and Reporting Group)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Data Management and Reporting Group)

Budget (Data Management and Reporting Group)

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

Provide a unified budget for the staffing necessary to conduct the functions of the CDMG for all three subject area groups – ADG, TG and AADG. The Data Management and Reporting Group Leader will be required to commit not less than 2.4 calendar months per year to the project. 

Budget assumptions should include transition of the different datasets and functions performed by the incumbents.  The current data management systems and formats utilized for ITN studies below are representative of most of the data platforms:

Budgets should also include costs associated with data transfers.

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

PHS 398 Research Plan          (Data Management and Reporting Group)

Specific Aims:  Briefly describe the specific aims of the DMRG.

Research Strategy:

DMRG Structure and Staffing:  

Describe in detail plans for the structure and staffing of the DMRG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. Include: (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project for all key DMRG personnel serving in a senior role; (ii) descriptions of the responsibilities of all proposed functional entities within the DMRG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role; (iii) proposed processes for decision-making, for resolving operational issues/problems, and for communication within the DMRG, between the DMRG and other Center groups, with multiple DAIT Branches and Offices involved in clinical research planning, execution, oversight and reporting, with PDs/PIs and senior investigators of DAIT-supported clinical research programs, and with other DAIT-supported clinical research support organizations; and (iv) proposed processes and procedures to ensure the timely and effective implementation of Group functions across all clinical research programs and projects, track progress, identify and resolve technical and operational issues, and monitor the use and adequacy of allocated resources.

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the proposed structure and staffing of the Group.

DMRG Functions: 

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:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this component.

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 (Data Management and Reporting Group)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Data Management and Reporting Group)

Not Applicable

Safety Oversight and Reporting Group (SORG) Component

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

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

SF424 (R&R) Cover (Safety Oversight and Reporting Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Safety Oversight and Reporting Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Safety Oversight and Reporting Group)

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

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

Project Narrative:  Do not complete.  Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Safety Oversight and Reporting Group)

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 (Safety Oversight and Reporting Group)

Budget (Safety Oversight and Reporting Group)

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

Provide a unified budget for the staffing necessary to conduct the functions of the CSOG for all three subject area groups – ADG, TG and AADG. The Safety Oversight and Reporting Group leader will be required to commit not less than 2.4 calendar months per year to the project.

Safety Reporting:

On average, the number of initial SAEs received per year is:

Further information about SAEs processed by the Safety Reporting Center is available at http://www.niaid.nih.gov/about/organization/dait/Documents/ClinicalWorkBreakdownSfc.pdf.

Data and Safety Monitoring Boards:

Further information about DSMB/SMCs activities is available at http://www.niaid.nih.gov/about/organization/dait/Documents/ClinicalWorkBreakdownSfc.pdf.

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 (Safety Oversight and Reporting Group)

Specific Aims:  Briefly describe the specific aims of the SORG.

Research Strategy:

SORG Structure and Staffing: 

Describe in detail plans for the structure and staffing of the SORG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. Include:  (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project of all key SORG personnel serving in a senior role; (ii) descriptions of the responsibilities of all proposed functional entities within the SORG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role; (iii) proposed processes for decision-making, for resolving operational issues/problems, and for communication within the SORG, between the SORG and other Center groups, with multiple DAIT Branches and Offices involved in clinical research planning, execution, oversight and reporting, with PDs/PIs and senior investigators of DAIT-supported clinical research programs, and with other DAIT-supported clinical research support organizations; and (iv) proposed processes and procedures to ensure the timely and effective implementation of Group functions across all clinical research programs and projects, track progress, identify and resolve technical and operational issues, and monitor the use and adequacy of allocated resources.

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the proposed structure and staffing of the Group.

SORG Functions:

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:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this component.

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 (Safety Oversight and Reporting Group)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Safety Oversight and Reporting Group)

Not Applicable

Ancillary Services Group (ASG) Component

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

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

SF424 (R&R) Cover (Ancillary Services Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Ancillary Services Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Ancillary Services Group)

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

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

Project Narrative:  Do not complete.  Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Ancillary Services Group)

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 (Ancillary Services Group)

Budget (Ancillary Services Group)

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

Provide a unified budget for the staffing necessary to conduct the functions of the ASG for all three subject area groups – ADG, TG and AADG.  The Ancillary Services Group leader will be required to commit not less than 2.4 calendar months per year to the project.

Sample tracking:

Materials for laboratory testing:

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          (Ancillary Services Group)

Specific Aims:  Briefly describe the specific aims of the ASG.

Research Strategy:

ASG Structure and Staffing: 

Describe in detail plans for the structure and staffing of the ASG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. Include: (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project of all key ASG personnel serving in a senior role; (ii) descriptions of the responsibilities of all proposed functional entities within the ASG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role; (iii) proposed processes for decision-making, for resolving operational issues/problems, and for communication within the ASG, between the ASG and other Center groups, with multiple DAIT Branches and Offices involved in clinical research planning, execution, oversight and reporting, with PDs/PIs and senior investigators of DAIT-supported clinical research programs, and with other DAIT-supported clinical research support organizations; and (iv) proposed processes and procedures to ensure the timely and effective implementation of Group functions across all clinical research programs and projects, track progress, identify and resolve technical and operational issues, and monitor the use and adequacy of allocated resources.

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the proposed structure and staffing of the Group.

ASG Functions:

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:

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.

Planned Enrollment Report (Ancillary Services Group)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Ancillary Services Group)

Not Applicable

Bioinformatics Group (BG) Component

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

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

SF424 (R&R) Cover (Bioinformatics Group)

Complete only the following fields:

PHS 398 Cover Page Supplement (Bioinformatics Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Bioinformatics Group)

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

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

Project Narrative:  Do not complete.  Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Bioinformatics Group)

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 (Bioinformatics Group)

Budget (Bioinformatics Group)

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

Provide a unified budget for the staffing necessary to conduct the functions of the BG for all three subject area groups – ADG, TG and AADG. The Bioinformatics Group leader will be required to commit not less than 2.4 calendar months per year to the project.

Assume that the BG phases-in over two years.  Plan to initially provide a collaborative portal space for data review and analyses as well as displays of sample storage (dates, quantity, type of biologic sample, etc.)

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          (Bioinformatics Group)

Specific Aims:  Briefly describe the specific aims of the BG.

Research Strategy:

BG Structure and Staffing:

Describe in detail plans for the structure and staffing of the BG.  Additional organizational entities, e.g., groups, sub-groups, committees, etc., may be established to carry out specific scientific, technical, and administrative responsibilities and/or to participate in the planning, conduct and management of Center activities. Include:  (i) descriptions of recent projects of similar scope and complexity and the level and scope of responsibility for each project of all key BG personnel serving in a senior role; (ii) descriptions of the responsibilities of all proposed functional entities within the BG, and delineation of lines of authority and reporting among proposed Center personnel serving in a senior role; (iii) proposed processes for decision-making, for resolving operational issues/problems, and for communication within the BG, between the BG and other Center groups, with multiple DAIT Branches and Offices involved in clinical research planning, execution, oversight and reporting, with PDs/PIs and senior investigators of DAIT-supported clinical research programs, and with other DAIT-supported clinical research support organizations; and (iv) proposed processes and procedures to ensure the timely and effective implementation of Group functions across all clinical research programs and projects, track progress, identify and resolve technical and operational issues, and monitor the use and adequacy of allocated resources.

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the proposed structure and staffing of the Group.

BG Functions:

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:

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.

Planned Enrollment Report (Bioinformatics Group)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Bioinformatics Group)

Not Applicable

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.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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? Does the application as a whole demonstrate a sound and thorough understanding of key problems and difficulties in conducting human subjects research for immune-mediated diseases? Does the Center have the potential to lead to improvements in the design, conduct and analysis of clinical research in the three disease areas?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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 Center 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 Center? Are the qualifications of the PD/PI proposed to serve as the Director of the Leadership Group (LG) well documented and appropriate for directing, managing and coordinating the Center’s scientific, technical, operational and fiscal support activities, particularly for large, complex and multifaceted clinical research programs, and will this individual devote adequate time and effort?  For applications proposing multiple PDs/PIs, are the roles and responsibilities of PD(s)/PI(s) not proposed to serve as the LG Director clearly defined and well justified relative to the full scope of Center responsibilities?  Do these PD(s)/PI(s) have well documented qualifications to perform the responsibilities proposed, and will they devote adequate time and effort? Is the proposed mix of expertise and experience represented by the Disease-Specific and Centralized Group Leaders and senior personnel well justified and well suited to the scope of the Center’s scientific, clinical, technical and operational support functions? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Does the application as a whole demonstrate a sound understanding of innovative approaches to study design and statistical analysis of clinical research and mechanistic data, including the use of innovative bioinformatics tools and methodologies for the study of immune-mediated diseases? 

Approach

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

If the Center 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?  

Is the overall plan for the organization of the Center comprehensive?  Does it provide for a well-integrated entity with an effective governance structure and clearly defined processes for decision-making, collaboration, coordination and communication? Are there sound, appropriate, feasible standards and criteria for evaluating the importance and relevance of the design, development, initiation, monitoring and analysis of clinical research in the three disease areas?  Does the Center have appropriate experience with respect to statistical and clinical coordination of programs/projects of the similar size and scope in all three disease areas? 

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 Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Do the accomplishments, experience and expertise of the applicant organization demonstrate the capability to effectively and efficiently support the full scope of statistical and clinical coordination functions in each of the three disease areas? 

Review Criteria for Leadership Group (LG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed LG structure clearly defined and does it provide for effective and efficient planning, direction and management of the scientific, clinical, operational and administrative activities of the Center as a whole? Are proposed processes for decision-making, resolving technical and operational issues, and communication clearly articulated and appropriate? Do the LG Director, Senior Project Manager, and other senior LG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Functions

Are proposed project management and tracking systems clearly defined, feasible and appropriate for overseeing effective planning and implementation of the full scope of Center activities? Are proposed plans for managing Center resources, including financial management capacity and systems, fully defined and feasible, particularly for a high volume of clinical research projects; will they contribute to maximizing the efficient use of available resources across all disease areas and clinical research programs? Does the application propose effective, efficient and reliable information management system(s) to support day-to-day Center activities and study-specific collaboration portals? Are there appropriate plans and meaningful metrics for evaluating Center performance and productivity, and is the proposed frequency of such evaluations adequate? Are there appropriate and efficient plans for assisting in COI management and providing technical and administrative support for meetings/teleconferences?

Review Criteria for Autoimmune Diseases Group (ADG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed ADG structure, including all functional entities, clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of Group functions? Are the lines of authority clearly delineated? Does the application clearly articulate appropriate processes within the Group for decision-making, communication, collaboration, resolution of technical and operational issues, and monitoring the use and adequacy of allocated resources? Do the proposed Group Leader and other senior ADG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Statistical Design and Analysis

Does the application demonstrate a sound and comprehensive understanding of the statistical design and analysis considerations of particular relevance and importance for the full scope of clinical research in this disease area? Are statistical design and analysis methodologies identified as high priority scientifically sound and well justified? Does the application demonstrate a sound and thorough understanding of common statistical design and analysis problems and difficulties in this disease area, and are approaches recommended to overcome/improve identified problems and difficulties well founded and likely to optimize the yield from experimental strategies? Does the application demonstrate a solid understanding of emerging statistical design and analysis methodologies and their applicability to autoimmune diseases? Are the plans and procedures proposed for performing the full scope of statistical design and analysis functions clearly defined and appropriate to ensure a high level of quality for clinical protocols, statistical analyses, assistance with reports needed for regulatory requirements and safety monitoring, and publication/presentation of study results?   

Protocol Development

Does the application demonstrate a sound and thorough understanding of critical aspects, considerations, and common problems and difficulties involved in protocol development for the full scope of research and research programs in this disease area? Are approaches recommended to overcome/mitigate common problems and difficulties sound and appropriate? Are the plans and procedures proposed for performing protocol development functions clearly defined and likely to contribute to both the quality of clinical protocols and the efficiency of the protocol development process?    

Study Initiation and Management

Does the application demonstrate a sound and thorough understanding of critical aspects and considerations for study initiation, clinical site training, and study management, coordination and conduct for the full scope of research and research programs in this disease area?  Does the application adequately identify and propose effective approaches to overcome/mitigate common problems and deficiencies in study initiation and conduct, including clinical site training? Are the plans and procedures proposed for supporting study initiation and management activities sound and thorough; will they contribute to ensuring effective communication and coordination; consistency in study implementation across multiple sites/laboratories; appropriate review of study implementation on an ongoing basis; and the efficient implementation of strategies to correct/improve study performance and productivity?

Review Criteria for Transplantation Group (TG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed TG structure, including all functional entities, clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of Group functions? Are the lines of authority clearly delineated?  Does the application clearly articulate appropriate processes within the Group for decision-making, communication, collaboration, resolution of technical and operational issues, and monitoring the use and adequacy of allocated resources? Do the proposed Group Leader and other senior TG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Statistical Design and Analysis

Does the application demonstrate a sound and comprehensive understanding of the statistical design and analysis considerations of particular relevance and importance for the full scope of clinical research in this disease area? Are statistical design and analysis methodologies identified as high priority scientifically sound and well justified? Does the application demonstrate a sound and thorough understanding of common statistical design and analysis problems and difficulties in this disease area, and are approaches recommended to overcome/improve identified problems and difficulties well founded and likely to optimize the yield from experimental strategies? Does the application demonstrate a solid understanding of emerging statistical design and analysis methodologies and their applicability to transplantation? Are the plans and procedures proposed for performing the full scope of statistical design and analysis functions clearly defined and appropriate to ensure a high level of quality for clinical protocols, statistical analyses, assistance with reports needed for regulatory requirements and safety monitoring, and publication/presentation of study results?   

Protocol Development

Does the application demonstrate a sound and thorough understanding of critical aspects, considerations, and common problems and difficulties involved in protocol development for the full scope of research and research programs in this disease area? Are approaches recommended to overcome/mitigate common problems and difficulties sound and appropriate? Are the plans and procedures proposed for performing protocol development functions clearly defined and likely to contribute to both the quality of clinical protocols and the efficiency of the protocol development process?    

Study Initiation and Management

Does the application demonstrate a sound and thorough understanding of critical aspects and considerations for study initiation, clinical site training, and study management, coordination and conduct for the full scope of research and research programs in this disease area?  Does the application adequately identify and propose effective approaches to overcome/mitigate common problems and deficiencies in study initiation and conduct, including clinical site training? Are the plans and procedures proposed for supporting study initiation and management activities sound and thorough; will they contribute to ensuring effective communication and coordination; consistency in study implementation across multiple sites/laboratories; appropriate review of study implementation on an ongoing basis; and the efficient implementation of strategies to correct/improve study performance and productivity?

Review Criteria for Asthma and Allergic Diseases Group (AADG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed AADG structure, including all functional entities, clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of Group functions? Are the lines of authority clearly delineated? Does the application clearly articulate appropriate processes within the Group for decision-making, communication, collaboration, resolution of technical and operational issues, and monitoring the use and adequacy of allocated resources? Do the proposed Group Leader and other senior AADG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Statistical Design and Analysis

Does the application demonstrate a sound and comprehensive understanding of the statistical design and analysis considerations of particular relevance and importance for the full scope of clinical research in this disease area? Are statistical design and analysis methodologies identified as high priority scientifically sound and well justified? Does the application demonstrate a sound and thorough understanding of common statistical design and analysis problems and difficulties in this disease area, and are approaches recommended to overcome/improve identified problems and difficulties well founded and likely to optimize the yield from experimental strategies? Does the application demonstrate a solid understanding of emerging statistical design and analysis methodologies and their applicability to autoimmune diseases? Are the plans and procedures proposed for performing the full scope of statistical design and analysis functions clearly defined and appropriate to ensure a high level of quality for clinical protocols, statistical analyses, assistance with reports needed for regulatory requirements and safety monitoring, and publication/presentation of study results?   

Protocol Development

Does the application demonstrate a sound and thorough understanding of critical aspects, considerations, and common problems and difficulties involved in protocol development for the full scope of research and research programs in this disease area? Are approaches recommended to overcome/mitigate common problems and difficulties sound and appropriate? Are the plans and procedures proposed for performing protocol development functions clearly defined and likely to contribute to both the quality of clinical protocols and the efficiency of the protocol development process?

Study Initiation and Management

Does the application demonstrate a sound and thorough understanding of critical aspects and considerations for study initiation, clinical site training, and study management, coordination and conduct for the full scope of research and research programs in this disease area?  Does the application adequately identify and propose effective approaches to overcome/mitigate common problems and deficiencies in study initiation and conduct, including clinical site training? Are the plans and procedures proposed for supporting study initiation and management activities sound and thorough; will they contribute to ensuring effective communication and coordination; consistency in study implementation across multiple sites/laboratories; appropriate review of study implementation on an ongoing basis; and the efficient implementation of strategies to correct/improve study performance and productivity?

Atopic Dermatitis Research Network (ADRN) Subject Registry

Is the proposed structure of the ADRN Subject Registry clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of registry functions? Do the senior staff proposed possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort? Is the computerized database management system proposed effective, efficient and reliable; does it provide for the necessary system capabilities; and are appropriate quality assurance/quality control procedures in place to ensure data accuracy and completeness? Are descriptions of proposed SOPs, instructions on system use, and plans for clinical site training appropriate and sufficient to ensure smooth functioning?

Inner City Asthma Consortium (ICAC) Clinical Specimen Repository

Is the proposed structure of the ICAC Clinical Specimen Repository clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of repository functions? Do the senior staff proposed possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort? Is the computerized database management system(s) proposed effective, efficient and reliable; does it provide for the necessary system capabilities; and are appropriate quality assurance/quality control procedures in place? Are descriptions of proposed SOPs, instructions on system use, and plans for clinical site training appropriate and sufficient to ensure smooth functioning?

Review Criteria for Clinical Site Monitoring Group (CSMG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed CSMG structure, including all functional entities, clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of Group functions? Does the application clearly articulate appropriate processes for decision-making, communication, collaboration, resolution of technical and operational issues, and monitoring the use and adequacy of allocated resources? Do the proposed Group Leader and other senior CSMG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Functions

Does the application demonstrate a sound and thorough understanding of common clinical site performance and compliance problems and deficiencies in general and for the three specific disease areas, and identify effective strategies for ensuring appropriate corrective/remedial actions? Are the SOPs, plans and procedures proposed for performing the full scope of clinical site monitoring functions, including preparing clinical sites for external audits (e.g., FDA, pharmaceutical partners) clearly defined and appropriate to ensure full compliance with regulatory requirements and guidelines and NIH and NIAID policies? Are proposed plans for training site monitors clearly articulated and will they ensure adequate capability to provide the full scope of clinical site monitoring support?

Review Criteria for Data Management and Reporting Group (DMRG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed DMRG structure, including all functional entities, clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of Group functions? Does the application clearly articulate appropriate processes within the Group for decision-making, communication, collaboration, resolution of technical and operational issues, and monitoring the use and adequacy of allocated resources? Do the proposed Group Leader and other senior DMRG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Functions

Are the data management system and procedures proposed for both clinical and laboratory study data and safety data effective, efficient and reliable; do they provide for the necessary system capabilities; and are appropriate quality assurance/quality control procedures in place? Is the data quality control system proposed comprehensive, efficient and reliable; does it provide for standardization in data collection and other necessary system capabilities; and are components of proposed manuals documenting standards and procedures comprehensive and appropriate? Are adequate and reasonable plans in place for training clinical site personnel on all aspects of data management and submission?

Review Criteria for Safety Oversight and Reporting Group (SORG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed SORG structure, including all functional entities, clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of Group functions? Does the application clearly articulate appropriate processes within the Group for decision-making, communication, collaboration, resolution of technical and operational issues, and monitoring the use and adequacy of allocated resources? Do the proposed Group Leader and other senior SORG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Functions

Are proposed plans and procedures for operating the Safety Reporting Center comprehensive and appropriate with a well-defined list of SOPs on SAE reporting, a sound and efficient process for evaluating SAE Reports, and effective plans for clinical site training on system use? Does the application demonstrate a thorough and sound understanding of common problems/deficiencies in clinical site performance with respect to SAE reporting and provide effective recommendations for resolving problems/deficiencies? Are proposed plans and procedures for supporting DSMB activities clearly defined and appropriate; will they contribute to smooth functioning and careful records maintenance?

Review Criteria for Ancillary Services Group (ASG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed ASG structure, including all functional entities, clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of Group functions? Does the application clearly articulate appropriate processes within the Group for decision-making, communication, collaboration, resolution of technical and operational issues, and monitoring the use and adequacy of allocated resources? Do the proposed Group Leader and other senior ASG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Functions

Is the proposed computerized database system(s) for sample tracking effective, efficient and reliable; does it provide for the necessary system capabilities, including site and study-specific reconciliation of samples and data results? Are instructions for use of the sample tracking system complete and well documented, and are proposed plans for training users effective? Are efficient and comprehensive methods proposed for the design, purchase, packing and shipping of materials for specialized laboratory tests? Is the proposed plan for provision of materials for laboratory testing comprehensive and appropriate?

Review Criteria for Bioinformatics Group (BG) Component

This component will receive one individual score; the subcategories listed will be assessed but not scored separately.

Structure and Staffing

Is the proposed BG structure, including all functional entities, clearly defined and does it provide for effective and efficient planning, implementation, management and tracking of Group functions? Does the application clearly articulate appropriate processes within the Group for decision-making, communication, collaboration, resolution of technical and operational issues, and monitoring the use and adequacy of allocated resources? Do the proposed Group Leader and other senior BG staff possess the expertise and experience relevant for their roles/responsibilities and devote adequate effort?

Functions 

Do the proposed data management system and software tools provide effective data integration and analysis support for the disease-specific areas specified? Is the quality management plan proposal sufficient to assure confidence in the data being analyzed from different laboratories? Is the plan for data dissemination to a wide variety of data users clear and effective? Is the description of the infrastructure for the BG sufficient to support the scope of the activities that are required? Are the plans that are provided in support of DAIT-funded investigators developing study proposals; collaborations with investigators for in-depth analyses; and analyses across individual studies clearly articulated and effective? Does the application adequately plan to provide training to users of the proposed resources? 

Additional Review Criteria

As applicable for the Center 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 Center 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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the Center 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 DHHS, 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:

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

NIAID staff assistance will be provided by NIH Project Scientists in each of the three disease areas who will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond the normal program stewardship role for grants.  These staff will be identified at the time of award and their roles and responsibilities will be addressed in the Notice of Grant Award.  It is anticipated that decisions regarding Center activities will be reached by consensus and that the NIH Project Scientists will participate in this process.  In various matters related to clinical study approval and oversight, NIH Project Scientists will have final decision authority, as described below.

Areas of Joint Responsibility include:

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 Center, 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.

All PD(s)/PI(s) must include a list of training programs conducted for clinical site personnel and written assessments in their Annual Progress Report.

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)

Finding Help Online: http://grants.nih.gov/support/index.html

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)

Leighton Thomas
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3522
Email: lathomas@niaid.nih.gov

Peer Review Contact(s)

Paul Amstad, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-7098
Email: pamstad@mail.nih.gov

Financial/Grants Management Contact(s)

Tina M. Carlisle
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6579
Email: tc48k@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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