Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for an Allergy and Asthma Statistical and Clinical Coordinating Center (AA-SCCC) to provide a broad range of support critical for the design, development, execution, and analysis of clinical research in allergic diseases and asthma. The major clinical research programs to be supported by the AA-SCCC include the Atopic Dermatitis Research Network, Consortium for Food Allergy Research, Childhood Asthma in Urban Settings Clinical Research Network, and Immune Tolerance Network. The AA-SCCC may also support investigator initiated clinical trials (IICT), and other clinical trial/study activities funded by NIAID. The types of research for which support will be provided include clinical trials, integrated studies of underlying mechanisms, clinical studies (e.g., longitudinal observational studies, genetic studies, etc.), and studies to identify and validate surrogates/biomarkers.

Background

The causes, pathogenesis, diagnosis, treatment, and prevention of allergic diseases and asthma are major areas of emphasis for NIAID. NIAID pursues research on allergic diseases and asthma by supporting investigator-initiated research projects and national networks of research centers. A critical component of NIAID's mission focuses on clinical research to develop new and/or improved strategies to treat or prevent allergic diseases and asthma through rigorous evaluations of the efficacy and safety of investigational products and therapeutic interventions, studies to elucidate underlying mechanisms of disease, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and observational clinical studies of disease natural history.

The NIAID clinical research programs to be supported by the AA-SCCC include those described below. During the course of the AA-SCCC, other clinical programs may also need to be supported. Current ongoing work supporting within scope functions will transfer at the time of award to the AA-SCCC grantee.

Atopic Dermatitis Research Network (ADRN). Through the ADRN, NIAID supports clinical research and limited related basic research on the immunopathogenesis of atopic dermatitis (AD) focusing on its association with cutaneous infections and bacterial colonization. The ADRN covers the following research areas: (i) analysis of immune and skin barrier impairments leading to cutaneous viral (e.g., Herpes simplex) and bacterial (e.g., Staphylococcus aureus) infections; (ii) the role of the skin microbiome in host defense, including the effects of microbiome perturbations on cutaneous immunity, and the effects of targeted biologic treatments on the skin microbiome; (iii) the role of proteins of both the stratum corneum and the tight junctions, as well as the role of cutaneous lipids in host defense and in the chronic inflammatory aspects of AD; (iv) the genetic and epigenetic basis of the cutaneous host defense abnormalities and the chronic inflammatory aspects of AD in children and adults; (v) comparison of immune responses to cutaneous pathogens in AD versus other chronic or inflammatory skin conditions, such as psoriasis or ichthyosis; (vi) developing and validating sample-sparing assays and non-invasive methods to study cutaneous immunity in infancy; (vii) characterizing the cutaneous microbiome in infancy; (viii) designing and conducting clinical trials to prevent or improve AD and its chronic consequences on skin function and defenses in adults or children, as well as on the progression of atopic diseases in children; and (ix) designing and conducting observational clinical studies to assess AD phenotypes/endotypes. Investigations include early and late phase clinical trials, clinical studies using human samples, and integrated studies of underlying mechanisms. Currently, the ADRN is composed of a Leadership Center and six clinical research sites with the capacity to add clinical sites when necessary to complete clinical trials and clinical studies in a timely manner. The current ADRN maintains a registry of AD subjects and controls with patient-specific information and results from laboratory tests.

Consortium for Food Allergy Research (CoFAR). Through CoFAR, NIAID supports clinical research that focuses on: (i) developing new approaches to treat and prevent IgE-mediated food allergy, including food allergy-associated anaphylaxis and food allergy-associated eosinophilic gastrointestinal disease; (ii) identifying mechanisms underlying the natural histories of these disorders; and (iii) defining the genetic components of these disorders. The scope of clinical research carried out includes: (i) single and multi-site Phase I and Phase II clinical trials of therapeutic and preventive approaches; (ii) Phase III clinical trials; (iii) observational/natural history and birth cohort studies using human subjects with integrated mechanistic studies; and (iv) genetic studies using human subjects including replication and/or functional studies. This research program currently supports a Leadership Center and seven clinical research sites with the capacity to add clinical sites when necessary to complete clinical trials and clinical studies in a timely manner.

Childhood Asthma in Urban Settings (CAUSE) Clinical Research Network. The overall objective of CAUSE is to address the disproportionate burden of asthma among children living in low-income, urban communities by examining risk factors and developing effective interventions and asthma prevention approaches tailored to these communities. The scope of research carried out by this network includes: (i) clinical trials at all phases to improve asthma control and to prevent asthma development using immunomodulatory, pharmacologic, or environmental interventions; (ii) cross sectional phenotyping studies to improve asthma immunophenotyping and to identify differences leading to improved understanding of specific phenotype pathophysiology and the design of phenotype-specific therapeutic interventions; (iii) completion of the URECA longitudinal birth cohort study; (iv) mechanistic studies to improve understanding of the immunopathogenesis of asthma, elucidate the mechanisms and predict the efficacy of immunotherapeutic modalities, and identify and evaluate potential biomarkers of the induction, maintenance, and loss of immune tolerance in the context of allergic airway disease; and (v) the development, validation, and implementation of translational science methodology to support the primary outcomes of mechanistic studies. The CAUSE network is composed of a Leadership Center and seven Clinical Research Centers for the conduct of clinical trials and observational/mechanistic clinical studies and has the capacity to add clinical sites when necessary to complete clinical trials and clinical studies in a timely manner. CAUSE maintains a repository of biological samples from all its studies.

Immune Tolerance Network (ITN). This clinical network focuses on the mechanisms underlying the induction, maintenance, and loss of immune tolerance in humans. The research carried out by the ITN encompasses clinical trials at all phases to evaluate approaches for the induction and maintenance of immune tolerance with integrated mechanistic studies and immune tolerance assays. ITN activities in allergic diseases and asthma focus on tolerance induction through innovative allergen immunotherapy strategies, including but not limited to selectively amplifying immune responses, making immunotherapy more robust, durable and safer and shortening the time required to achieve beneficial and long-lasting immune responses. ITN clinical trials are also focused on preventing the development of allergic diseases through immune tolerance induction and preservation. More information about this research program is available at https://www.niaid.nih.gov/research/immune-tolerance-network.

Investigator-Initiated Clinical Trials (IICT). NIAID supports investigator-initiated clinical trials using the R01 or U01 funding mechanism. The AA-SCCC support may be required for up to two investigator-initiated clinical trials per year.

Biological specimens: In the vast majority of the research projects conducted by the NIAID allergy and asthma clinical networks biological specimens' collection is of high importance. Biological specimens are collected and stored with the intention to test pre-specified hypotheses, conduct unbiased, hypothesis-generating analyses, implementing systems biology analytic approaches, and providing a biorepository for future, disease-specific research.

Details of specific research studies to be supported by the AA-SCCC can be found here. The list of research studies to be supported by the AA-SCCC will not change while this FOA is active.

Note during the course of the award studies will conclude and additional studies will be designed and initiated.

Objectives and Scope

The objective of the AA-SCCC is to provide a broad range of support critical for the design, development, execution, and analysis of the clinical studies that NIAID sponsored clinical research programs in allergic diseases and asthma conduct. 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 disease mechanisms or mechanisms of action of therapeutic modalities as integral components of clinical trials; (iii) observational clinical studies (e.g., longitudinal birth cohort studies, genetic studies, studies designed with the main purpose to assess mechanisms of disease etc.); and (iv) surrogate/biomarker studies. The scope of functions to be performed by the Center includes statistical design and analysis; protocol development; study initiation and management; and management of sample repositories. In addition, the AA-SCCC will be responsible for organizing and maintaining study management teams (SMTs) for every study in which it is involved and for the communication, collaboration, and assistance with the NIAID-supported Clinical Data and Safety Monitoring Center (CDSMC), Clinical Site Monitoring Center (CSMC), the NIAID Clinical Products Center (CPC) and with NIAID staff for planning, oversight, execution, and analysis of NIAID-supported research.

AA-SCCC Functions

A. STATISTICAL DESIGN AND ANALYSIS

The AA-SCCC will provide expertise, advice and assistance to study investigators and SMTs in the development of statistical design plans for concept and full study proposals for NIAID supported clinical research. The AA-SCCC will design and conduct interim and final statistical analyses of study data, prepare reports on the status of clinical trials and observational/mechanistic studies, participate in the preparation of scientific manuscripts and reports for publication and presentation at scientific meetings, and for reporting requirements, including support for safety monitoring by independent Data and Safety Monitoring Boards (DSMBs), Safety Monitoring Committees (SMCs), and other safety bodies established or utilized by NIAID and submission to appropriate regulatory health authorities.

B. PROTOCOL DEVELOPMENT, STUDY INITIATION AND STUDY PERSONNEL TRAINING

The AA-SCCC will provide expert advice and assistance to study investigators and SMTs in the development of protocols for clinical trials, observational and mechanistic studies, and will coordinate and provide appropriate expertise for the preparation, review and approval of protocol-related documents and materials, including SOPs for safeguarding confidentiality and intellectual property, in collaboration with NIAID, the CDSMC and other NIAID supported research services. The AA-SCCC will have the responsibility of training clinical site personnel in all protocol-related processes and procedures prior to initiation and during the course of a clinical study.

C. REPOSITORY AND TRACKING OF BIOLOGICAL SPECIMENS

The AA-SCCC will establish, operate, manage, and maintain central repository facilities for biological specimens generated by the studies that the NIAID-supported clinical research programs will conduct. Sample storage will be linked to sample tracking.

D. DATA MANAGEMENT SUPPORT

The AA-SCCC will assist, collaborate, and communicate with the CDSMC, study investigators, SMTs and NIAID in the development of the data management plan and design of study databases to ensure complete and accurate clinical data collection and security.

E. CLINICAL SAFETY AND PHARMACOVIGILANCE SUPPORT

The AA-SCCC will assist, collaborate, and communicate with the CDSMC, SMTs and NIAID to ensure appropriate monitoring of the safety of all human subjects participating in NIAID supported studies, and for ensuring appropriate implementation of safety procedures and adherence to safety oversight and reporting requirements.

F. CLINICAL STUDY INTERNET-BASED COLLABORATION PORTALS

The AA-SCCC will provide internet-based clinical study collaboration portals that are maintained and updated on an ongoing basis, to house clinical trial information and study-specific documents and materials. Portals will be protocol-specific, password protected and will provide access for the NIAID staff, clinical investigators and other clinical site personnel and industry collaborators.

G. PROJECT MANAGEMENT AND COMMUNICATIONS

The AA-SCCC will develop and implement a project management plan for the overall management, integration and coordination of all award activities, as described above. The AA-SCCC will manage, participate and provide technical support in NIAID-sponsored clinical research program Steering Committee, subcommittee and study-specific SMT meetings and teleconferences. The AA-SCCC will develop and implement processes for interaction, collaboration and effective communications between the AA-SCCC and 1) other NIAID-supported entities (e.g., CDSMC, CSMC), 2) multiple NIAID Branches and Offices involved in clinical research planning, execution, oversight, and reporting, 3) PDs/PIs and senior investigators of NIAID-supported clinical networks.

H. QUALITY ASSURANCE/QUALITY CONTROL

The AA-SCCC will develop and implement a Quality Assurance/Quality Control (QA/QC) plan designed to standardize its processes and provide for the assessment of its performance and the quality and timeliness of the clinical research support functions conducted.

The AA-SCCC will operate in compliance with:

• Current applicable US regulatory authority and/or public laws regulations located at Code of Federal Regulations Title 21 and 45 CFR 46 (e.g., 21 CFR 11, 21 CFR 50, 56, 312, 612 and 812 as applicable, 45 CFR 46 and/or similar statutes), including U.S. Public Law 110-85 or the Food and Drug Administration Amendments Act of 2007, as well as local regulations as applicable.
• Current globally-accepted standards, including the following: International Conference on Harmonization (ICH) E2, Clinical Safety Data Management, ICH E3 Clinical Study Reports, ICH E6 Good Clinical Practice, located at ICH Guidance Documents.
• M1 MedDRA Terminology and ICH M5, Data Elements and Standards for Drug Dictionaries, located at: http://www.ich.org/products/guidelines.html.
• The World Health Organization Drug Dictionary, located at https://www.who-umc.org/whodrug/whodrug-portfolio/whodrug-global/ current industry standards for clinical data management, current example Clinical Data Interchange Standards Consortium (C-DISC) located at: http://www.cdisc.org. Provisions to maintain compliance with changing industry standards must be in place.
• U.S. shipping of biospecimens requires observance of Department of Transportation (DOT) and International Air Transit Association (IATA) regulations.

Clinical Research Support Resources provided by NIAID

Regulatory Sponsorship and Support

It is anticipated that, with rare exceptions, 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. The AA-SCCC will coordinate and collaborate with the NIAID 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 Data and Safety Management Center (CDSMC)

The NIAID CDSMC will support a wide range of clinical research data management activities for NIAID-funded clinical trials and clinical studies. These include building and programming of study databases, data collection and management, data quality management and control, clinical safety, and pharmacovigilance and safety oversight structure support.

Clinical Site Monitoring Center (CSMC)

The NIAID CSMC will be responsible for the clinical monitoring of clinical trials and other clinical studies in accordance with protocol-specific and regulatory requirements, including initial site assessments, interim site monitoring of ongoing studies, and site and study close-out.

Clinical Products Center (CPC)

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

Immunology Database and Analysis Portal (ImmPort)

ImmPort, supported by a NIAID contract, provides advanced information technology support in the archiving and exchange of scientific data and serves as a long-term, sustainable archive of research and clinical data. The AA-SCCC will collaborate with ImmPort and CDSMC for the sharing of clinical and mechanistic study data, in accordance with data standard and exchange formats, for long-term archiving and for public data sharing. See https://immport.niaid.nih.gov/home

Two FOAs relevant to this FOA are those for the NIAID Clinical Data and Safety Management Center (CDSMC) and for the Transplantation Statistical and Clinical Coordinating Center (T-SCCC).

Please refer to the Frequently Asked Questions (FAQ) page for additional guidance.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

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

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

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

Applicant Organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Lindsey Pujanandez, Ph.D.
Telephone: 301-761-7830
Email: [email protected]

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

For this specific FOA, the Research Strategy is limited to 30 pages.

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

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

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

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

Facilities and Other Resources:

Describe:

• Office space to house technical and management staff and equipment
• Data storage facilities
• Central biorepository facility for receipt, storage, management, inventory and disbursement of biological specimens
• Resources for remote training of clinical network personnel
• Other resources necessary to communicate, direct, oversee, coordinate, and carry out award activities
• 24-hour security systems to prevent theft, misuse or damage of study data, records, and logs, including locked and controlled access for authorized personnel only, programs or systems for protection from fire, water and other disasters, off-site data backup and redundant telephone and internet services to ensure continuous operation

Other Attachments:

Transition Plan

Applications must include a Transition Plan attachment that must be in pdf format with a filename of "Transition Plan.pdf." The attachment is limited to 12 pages total and must have clearly marked sections for Initial Transition Plan and Final Transition Plan. Applications that do not include a Transition Plan will be considered incomplete and will not be reviewed.

Initial Transition Plan

Currently, the functions of the AA-SCCC are part of an ongoing award (https://reporter.nih.gov/search/IwexnTgTYU2ne1l68kdbDQ/project-details/10589242) that also supports similar functions for other NIAID scientific domains (Autoimmunity and Transplantation). A transition of work from the current award is required. Include an Initial Transition Plan that describes plans, procedures, and timelines to ensure an orderly, secure, and efficient initial transition of all allergy and asthma study related materials, data, standard operating procedures, and any other related documents and to assume all AA-SCCC study activities. Data and materials to be transitioned include the following:

• Draft protocols for clinical trials and studies in development, final protocols and protocol amendments for ongoing clinical trials and studies, and final protocols and protocol amendments for completed clinical trials and studies
• All analysis datasets for clinical (DSMB, interim and final analyses and mechanistic) studies
• All other study-related materials for ongoing and completed clinical trials and studies, as well as clinical trials and studies in development, including informed consent forms, case report forms, manuals of operations, investigator brochures, and other documents
• Data and other information contained in study-specific websites and procedures for access control
• User manuals and all written instructions for utilization of the AA-SCCC data management system, as applicable
• Instructions and standard operating procedures for safety reporting
• Site monitoring reports, records, forms, templates, and procedures
• Biological specimens in current repositories, associated electronic files, and other records

Final Transition Plan

Include a Final Transition Plan that describes plans to maintain full operational capacity until the completion date of the grant. Plans should include coordination and implementation of an orderly, secure, and efficient transition of data and biological specimens, protocol-related documents, standard operating procedures, and other materials as designated by NIAID. AA-SCCC-generated materials and data to be transitioned include the following:

• All items listed in the Initial Transition above
• If not already provided, clean, edited, public use datasets (including cleaned data with or without images, raw data if cleaned data are not available) and copies of all data management tools, including data documentation, data dictionaries, and data entry software and editing programs to allow reading and analysis of the data for all studies managed or analyzed under the AA-SCCC grant. This includes all software used for reading, cleaning, manipulating, graphing and analyzing data and programs used for generating new datasets; audit trails of all data corrections, hard copies of the original data, if collected under this grant, and all logs and records related to data collection, entry, editing, verification, analysis and transfer; final summaries of analyses performed during the grant period of performance; all electronic files transferred and documentation of format to a location specified by NIAID by the grant completion date; and all hard copy files, including all reports submitted to NIAID, in an organized manner, providing clear documentation of contents, date of origin, and purpose to a location specified by NIAID prior to the grant completion date.

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

For individuals with statistical focus in the application, the biosketch should indicate their scientific contributions in developing and using innovative statistical and bioinformatic methodologies.

R&R or Modular Budget

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

The following information is provided to assist applicants with their budget requests:

The AA-SCCC will support 7-10 clinical trials in Phase I, II, or III at any given time, with an average approximate duration of 1-3 yr for recruitment/enrollment, and approximately 1-3 yr on average for active study participation (first subject, first visit to last subject last visit). The majority of clinical trials will be conducted under INDs. The AA-SCCC will also support 3-4 observational studies at any given time.

Specifically:

• The Atopic Dermatitis Research Network (ADRN) will be conducting 1-2 new interventional trials and 1 observational study during the first 2-3 years of the AA-SCCC. Each trial, involving 1-2 sites, will have 20-50 participants with 2 years duration. The observational study will have 600 participants at approximately 9 sites with 5 years duration.

• The Consortium for Food Allergy Research (CoFAR) will be conducting 1 new interventional trial and 2 ongoing studies (one 3-part Phase III interventional trial and one observational birth cohort) during the first 2-3 years of the AA-SCCC. Each trial, involving 10 sites, will have approximately 200 participants. The birth cohort will have approximately 2500 participants, will be conducted at 12 sites and will continue for the duration of the AA-SCCC award.

• The Childhood Asthma in Urban Settings (CAUSE) will be conducting 2 new interventional trials, 1 new observational study, and 1 ongoing observational study during the first 2-3 years of the AA-SCCC. Each trial and the new observational study will be conducted at 7 sites and will have approximately 350 participants. The ongoing observational study (URECA) is being conducted in 4 sites, has approximately 400 participants and will be completed within 2 years from the initiation of the AA-SCCC award.

• The Immune Tolerance Network (ITN) will be conducting 2 ongoing and 2-3 new interventional studies, during the first 2-3 years of the AA-SCCC. The 2 ongoing trials are single-center and have approximately 100 participants. Each new trial will be conducted at approximately 8 sites and will have approximately 150 participants. For ITN studies, the AA-SCCC will be only responsible for statistical planning and analysis.

AA-SCCC Biorepository

• The current DAIT/NIAID-supported biorepositories for allergic diseases and asthma hold over 250,000 aliquoted samples that will need to be transferred to the AA-SCCC biorepository
• For new biological specimens being generated during the duration of the AA-SCCC award, it is expected that, on average, 15 samples will be collected per study participant per year; samples may include, but are not limited to plasma, serum, PBMC, nasal secretions, sputum, skin biopsies, stool, nasal/skin swabs, urine; samples will be shipped to the AA-SCCC biorepository using AA-SCCC funds and, once arrived, some may need to be split into multiple aliquots.
• Note that, for studies conducted by the ITN, a network-specific biorepository and sample tracking system are available and AA-SCCC will not be required.

Additional budgetary considerations

• The AA-SCCC will conduct monthly periodic updates of adverse event listings
• Each ongoing trial or study requires safety reports to NIAID DSMBs every 6-12 months
• For each NIAID funded network the AA-SCCC will support, Steering Committee in person meetings take place 2-3 times per year with additional bi-weekly to monthly conference calls
• Award Initiation Meeting: There will be one meeting in Rockville, Maryland within 60 days after the effective date of the award; this meeting will require a two-night stay and will be attended by all of AA-SCCC key personnel

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

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

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

Specific Aims: Briefly describe the specific aims of the AA-SCCC.

Research Strategy: The Research Strategy should first describe the internal structure and organization of the AA-SCCC followed by plans, approaches, processes, and procedures to fulfill the requirements of AA-SCCC functions and responsibilities.

Provide a detailed description of the structure of the AA-SCCC that will allow it to carry out its scientific, technical, and administrative responsibilities.

• Describe the structure of the AA-SCCC leadership team; without duplicating information in the biosketch describe the training, expertise, experience, and other qualifications in leading and managing a Statistical and Clinical Coordinating Center for multi-center trials in a complex structure, and studies of relevant size and complexity and in the therapeutic areas to be studied. Address the Team's leadership experience (managing a diverse staff of scientific, clinical, technical and administrative personnel), working with government sponsors, regulatory authorities, government-supported clinical investigators, clinical trial networks, and industry collaborators, as well as scientific and technical expertise in protocol and statistical design, development, implementation, oversight of clinical trials and large observational studies, and statistical analysis.
• For each of the NIAID clinical networks in allergic diseases and asthma that the AA-SCCC will serve, provide lists of positions necessary for the various tasks and indicate if particular individuals within the organization are currently available to take on such tasks or are to be recruited for this purpose
• Describe lines of authority and internal interactions among the AA-SCCC personnel and the processes that will be in place for effective management, decision making, resolving operational issues/problems, and for efficient and effective internal communication
• Describe plans for ongoing internal training of AA-SCCC personnel
• List recent projects of similar scope and complexity indicating areas of success, as well as areas where important obstacles were met and how they were addressed by the organization

The use of tables, diagrams, flow charts and organizational charts is strongly recommended in describing the AA-SCCC structure and staffing.

Include the following clearly labeled sections:

A. STATISTICAL DESIGN AND ANALYSIS

• Discuss statistical approaches to be applied to specific types of clinical research protocols and elaborate on expertise in innovative solutions. Include sample size calculations, and design and conduct of interim and final statistical analyses.
• Describe processes for the preparation of study status reports, participation in the preparation of scientific manuscripts and reports for publication and presentation at scientific meetings, and for reporting requirements, including support for safety monitoring by independent Data and Safety Monitoring Boards (DSMBs), Safety Monitoring Committees (SMCs), and other safety bodies established or utilized by NIAID and submission to appropriate regulatory health authorities.

B. PROTOCOL DEVELOPMENT, STUDY INITIATION AND STUDY PERSONNEL TRAINING

Describe plans to:

• Coordinate and assist the SMTs in the design and development of protocols and all associated documents (e.g., informed consent forms, manual of procedures, investigator brochures, electronic case report forms, materials for study's Clinical Trials.gov registration record) for clinical trials and clinical studies. Discuss approaches to optimize the timeliness of these tasks.
• Assist in planning of study initiation meetings and developing materials to provide standard and study-specific training for clinical site personnel in multiple areas, (e.g., study procedures, data collection and entry, reporting and management of adverse events and serious adverse events).
• Train investigators and clinical site personnel in all protocol-related processes and procedures prior to study initiation and during the course of a clinical study.
• Ongoing internal training of AA-SCCC personnel.

C. REPOSITORY AND TRACKING OF BIOLOGICAL SPECIMENS

Provide a description of the biological specimen repository and the sample tracking system to be used with justification for the choice and describe plans and procedures for carrying out its operations. Include operational and risk reduction capabilities as well as quality assurance systems to ensure the safe storage of samples and to include back-up and disaster recovery contingencies.

D. DATA MANAGEMENT SUPPORT

Describe plans to assist, collaborate, and communicate with the CDSMC, SMTs and NIAID staff in the development of each study's database and data management plan to ensure complete and accurate data collection and security.

Describe plans for:

• Establishing and administering efficient, reliable, and responsive methods for accessing data from the CDSMC's primary databases for statistical analyses and for data storage, management, tracking, updating, quality control, archiving, and reporting
• Maintaining a computer-based system that is interoperable with NIAID computer-based systems, provides for secure electronic communication linkages and for extensibility without major refactoring to support new data types over the course of the award.

E. CLINICAL SAFETY AND PHARMACOVIGILANCE SUPPORT

• Describe plans to assist, collaborate, and communicate with the CDSMC, SMTs and NIAID staff to ensure appropriate monitoring of the safety of all human subjects participating in all clinical trials and clinical studies, and for appropriate implementation of safety procedures and adherence to safety oversight and reporting requirements.
• Provide plans for the AA-SCCC to specifically support activities such as generation of clinical safety reports for periodic reviews by the DSMB, local IRBs, Health Authorities, NIAID staff and clinical investigators, and for collaborating with the CDSMC for safety data reconciliation, performing surveillance of the clinical and safety databases and literature surveillance.

F. CLINICAL STUDY INTERNET-BASED COLLABORATION PORTALS

• Describe plans to create study-specific, password-protected clinical study collaboration portals that contain all basic study documents, other supportive materials (e.g., FAQs, instructions for clinical site staff on study procedures, order forms, tracking and dispense logs), and real-time standard and study-specific data by clinical site and overall (e.g., accrual, adverse event and serious adverse event listings, protocol deviation listings, missing forms and lab tests).
• Provide plans for maintaining portals up-to-date throughout the duration of an AA-SCCC-supported study.

G. PROJECT MANAGEMENT AND COMMUNICATIONS

• Present a plan for the overall management, integration and coordination of all award activities, including policies and procedures to assist with the function of the NIAID-sponsored clinical networks.
• Describe plans for supporting studies in various stages of activity (e.g., start-up, ongoing, closeout, analysis, and publication; written materials and oral presentations; preparing regular statistical reports).
• Describe the level of technical and administrative support to all network committees and SMTs to include scheduling and management of meetings/teleconferences, providing summaries of decisions, recommendations, and action items resulting from meetings/teleconferences and optimizing communications between the AA-SCCC and network investigators and staff, between the AA-SCCC and other entities (e.g., CDSMC, CSMC) and between AA-SCCC and NIAID staff.

H. QUALITY ASSURANCE/QUALITY CONTROL

Describe a Quality Assurance/Quality Control (QA/QC) Plan designed to assess the AA-SCCC performance and the quality and timeliness of its clinical research support functions. Include the following:

• Processes to be used to ensure internal QA and QC with respect to the timeliness, accuracy and completeness of the AA-SCCC functions and measures and metrics to be used to assess performance.
• Processes to ensure that all appropriate staff, facilities, and necessary documentation are available for independent audits of the AA-SCCC functions and that the AA-SCCC will promptly respond to the outcomes of such audits.

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

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• As part of the Data Sharing Plan, applicants should detail the procedures for sharing, release, and access of the materials, research tools, data and data analyses generated to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data Management and Sharing Guidelines.
• Awardees are expected to deposit data and data analyses into ImmPort or other public data portals as designated by NIAID. The Data Sharing Plan must ensure that the data are Findable, Accessible, Interoperable, and Reusable (FAIR) per the NIAID Data Management and Sharing Guidelines as appropriate and consistent with achieving the goals of the program.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Investigator(s)

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

Specific to this FOA:

How strong is the PD(s)/PI(s)' expertise in statistical design and analytical processes of clinical trials and studies of relevant size and complexity and in the therapeutic areas to be studied?

How much experience do the PD(s)/PI(s) and proposed staff have in the management of clinical trials and studies of relevant size and complexity and in the therapeutic areas to be studied?

Does the PD(s)/PI(s) have adequate experience in the process for regulatory requirements/activities associated with the statistical design and analysis of clinical trials conducted under IND or IDE?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

To what extent will the proposed program structure and staffing support multiple NIAID-funded allergic diseases and asthma clinical networks? How adequately are lines of authority delineated in the staffing plan? How adequate are the internal AA-SCCC staff training plans?

How well-described are the processes for developing protocols and other study-related documents? How well outlined are the proposed approaches to design and execution of statistical analysis plans and to what extent do they incorporate state-of-the-art methodology and concepts? How adequate are plans for supporting studies in various stages of activity (e.g., start-up, ongoing, closeout, analysis, and publication)? (e.g., written materials and oral presentations; preparing regular statistical reports).

How adequate are the plans for providing training to investigators and other clinical site staff prior to study initiation and during the course of a study?

How well-qualified is the proposed biorepository and how adequate is the approach to maintaining and managing it? To what extent is the proposed sample tracking system(s) effective, efficient, and reliable?; does it provide for the necessary system capabilities, including site- and study-specific reconciliation of samples and data results? How sufficient are the operational and risk reduction capabilities as well as quality assurance systems to ensure the safe storage of samples? How adequate are the back-up and disaster recovery contingencies?

Are plans and procedures for assisting, communicating and collaborating with other NIAID supported entities (e.g., CDSMC), SMTs, NIAID, and for data management and safety monitoring activities well-outlined and sufficient?

To what extent will the described web-based portals be effective in assisting clinical site investigators and staff with the conduct of clinical studies and trials?

How adequate is the proposed level of technical and administrative support in scheduling and managing meetings/teleconferences, providing summaries of decisions, recommendations, and action items and providing effective communications between all parties that the AA-SCCC will be interacting with?

To what extent are the QA/QC processes adequately outlined and how effective are they going to be in maintaining excellency in the functions of the AA-SCCC?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA:

To what extent do data management and security systems adequately meet the requirements described in the FOA, and to what extent do they meet compliance standards for sponsored research? How appropriate are the facilities and equipment to facilitate required virtual meetings and described training activities?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by convened by the National Institute of Allergy and Infectious Diseases, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 recipients for the project, as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

• Determining and coordinating the activities of the AA-SCCC; setting project goals and timelines.
• Accepting and implementing guidelines proposed by each NIAID clinical network Steering Committee and other network committees.
• Setting and abiding by project milestones for study initiation.
• Managing the clinical trials and studies conducted by the NIAID clinical networks and analyzing research data.
• Supporting NIAID activities in regulatory affairs.
• Serving as a voting member of the CAUSE, CoFAR, and ADRN Steering Committees and participate, in person or by designating critical staff, in network committees and in study-specific SMTs.
• Apprising the NIAID PO and any designated NIH project scientist(s) and medical monitor(s) of any potential impediments to execution of the objectives of a project.
• Ensuring that primary and secondary data, protocols, procedures, and any other project-derived resources are made available to the respective Steering Committees and investigators according to timelines agreed upon by SMTs, Steering Committees and NIAID.
• Agreeing not to disclose confidential information obtained from the NIAID clinical network investigators.
• Making the biological samples stored in the AA-SCCC repository and the research tools, methods, data, and materials developed under the AA-SCCC award available to the research community, consistent with the NIAID-approved policies established and decisions made by the relevant NIAID clinical networks' Steering Committee.
• Promoting rapid public access to data generated by the AA-SCCC-supported clinical trials and studies through ImmPort (https://immport.niaid.nih.gov) or other public portals designated by NIAID and consistent with achieving the goals of the program. The privacy of study participants must be safeguarded, and confidential and proprietary information must be protected.
• Transferring study related data in formats compliant with the DAIT Clinical Research Information System (CRIS), ImmPort, ClinicalTrials.gov, NIAID supported clinical research programs and pharmaceutical collaborators, and ensure that the NIAID Data Sharing Plan is properly implemented. Ensure complete transfer of all study related data before the end of the award.

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

The NIH Project Scientist 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.The NIH Project Scientist will provide leadership in this role and will be supported by other NIAID staff by:

• Providing guidance and support in the design of clinical protocols and all other research activities.
• Providing scientific/programmatic support during the execution and the data analysis of clinical trials and studies.
• Advising in the selection of sources or resources, and in the management and technical performance.
• Meeting regularly with the AA-SCCC leadership through conference/video calls and conducting at least once-a-year site visits.
• Participating in the decision-making process (developed through consensus) in all aspects of the function of the AA-SCCC.
• The NIAID Project Scientists or designees will have access to all data generated under this cooperative agreement and may review the data as recorded on case report forms or in databases. Data must be available for external checking against the original source documentation. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of any study supported by the AA-SCCC.
• A NIAID Program Officer will be responsible for the programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Ensuring consistency of the AA-SCCC functions with the NIAID-supported clinical network agendas and relevance with the NIAID scientific priorities.
• Reviewing the AA-SCCC activities and goals on an agreed-upon schedule (but no less than once every year). Promoting, evaluating, and executing opportunities to collaborate with other federal or non-federal research sponsors.

Dispute Resolution:

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

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

Lindsey Pujanandez, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7830
Email: [email protected]

Elizabeth Sihombing
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5530
Email: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.