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 the Transplantation Statistical and Clinical Coordinating Center (T-SCCC), which will support transplant clinical research conducted by NIAID. The awardee will provide a broad range of support critical for the design, development, implementation, and analysis of clinical research carried out by multiple NIAID-supported programs in transplantation. The scope of support to be provided includes statistical design and analysis, protocol development, final analysis of study findings, establishment and maintenance of a biospecimen tracking database, and support for the mechanistic studies by providing biospecimen labeling, shipping, and kits and/or bulk supplies for specimen collection. Additional critical infrastructure for NIAID supported clinical trials, including data management, regulatory support, clinical site monitoring, and drug labelling and distribution, will be managed by other separately funded entities. The T-SCCC will coordinate with these other entities, especially the Clinical Data Safety Monitoring Center (CDSMC), to ensure comprehensive, efficient, and seamless support for NIAID clinical transplantation research. The types of research for which support will be provided include clinical trials and other types of clinical studies (e.g., longitudinal studies, genetic studies, etc., and studies to identify and validate surrogates/biomarkers), with integrated studies of underlying immunologic mechanisms. Current ongoing work supporting within-scope functions will transfer at the time of award to the T-SCCC grantee.

Background

Organ transplantation is the treatment for end-stage organ failure when other therapies have failed or are not available, and when the person affected by organ failure is deemed likely to benefit from transplantation. The benefits of organ transplantation, as evidenced by prolonged survival and/or improved quality of life, have been clearly demonstrated for children and adults suffering from a wide range of congenital and acquired diseases. However, normal life expectancy and health-related quality of life are rarely, if ever, restored by organ transplantation. Although 1-year survival after organ transplantation has improved markedly over the last 15 years, there has been little success in reversing the decline in long-term graft and patient survival in recipients of an organ transplant. The prevalence of morbidities such as systemic hypertension, diabetes mellitus, renal insufficiency, and malignancy remain high in transplant recipients as compared with the general population. The barriers to short and long-term success of transplant procedures are predominantly the result of incompatibility between donor and recipient, acute and chronic rejection, and complications of long-term pharmacologic immune suppression. Important goals in NIAID-supported transplantation research include reducing the morbidities associated with pharmacological immunosuppression, the induction of transplant immune tolerance, and improved understanding of the immunologic response to allotransplantation.

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications for the T-SCCC to support clinical studies in organ transplantation conducted by investigators funded through a cooperative agreement mechanism including those participating in (1) Clinical Trials in Organ Transplantation (CTOT); (2) Clinical Trials in Transplantation in Children and Adults (CTOT-CA) 3) Transplantation trials conducted by the Immune Tolerance Network (ITN); and (4) Investigator- Initiated Clinical Trials (IICT).

Clinical Trials in Organ Transplantation (CTOT). The CTOT is a collaborative consortium that was funded from FY2002 to FY2021, composed of 57 clinical sites in the U.S. and Canada, for the conduct of cooperative, multi-center Phase I, II and III clinical trials, associated mechanistic studies, and observational clinical studies in adult candidates for and recipients of heart, liver, lung, and kidney transplants. Ongoing trials from the CTOT will be continued by the Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA). More information about the CTOT is available at https://www.niaid.nih.gov/research/clinical-trials-organ-transplantation. The CTOT initiative ended in 2021; however, ongoing studies continue to require support.

Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA). The CTOT-CA is a collaborative consortium conducting interventional trials (Phase I, II, or III) or observational clinical studies in organ transplantation (kidney lung, and liver). Each clinical study includes associated mechanistic studies that focus on relevant immune-mediated processes. The goals of this research are to further our understanding of and ultimately reduce immune- and infection-mediated morbidity and mortality associated with allotransplantation. Currently, seven research studies are in development, and up to two additional CTOT-CA studies may be initiated during the period of T-SCCC support.

Immune Tolerance Network (ITN) Transplantation. The ITN conducts clinical trials, mechanistic studies, and assay development in transplantation with a focus on tolerogenic approaches to improve the long-term outcomes of allotransplantation. Currently, there are five ongoing ITN trials in kidney and liver transplantation. The ITN develops one to two new trials in transplantation each year. More information about the ITN is available at https://www.niaid.nih.gov/research/immune-tolerance-network.

Investigator-Initiated Clinical Trials in Transplantation (IICT). NIAID supports investigator-initiated clinical trials using the R01 or U01 funding mechanism. T-SCCC support may be required for up to two new and eight ongoing investigator-initiated clinical trials per year.

The T-SCCC will provide a broad range of services for research conducted by the above groups, including provision of expertise in the design, development, implementation, and analysis of clinical trials and studies; technical and administrative support for Steering Committees, the yearly Mechanistic Studies Workshop, and the NIAID Transplantation Data and Safety Monitoring Board (DSMB); and materials for the conduct of mechanistic studies including specimen labels, kits or bulk supplies, and specimen shipping and tracking. The T-SCCC, in collaboration with the CDSMC, also will assist NIAID and the investigators in preparation of DSMB reports, scientific manuscripts, and other reports and documents as needed, and will assist NIAID in fostering collaborations among the consortia, networks, and individual investigators.

Objectives and Scope

The T-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.

The purpose of this FOA is to solicit applications for the Transplantation Statistical and Clinical Coordinating Center (T-SCCC), to support transplant clinical research conducted by NIAID. The awardee will be responsible for providing support in the following functional areas: statistical design and analysis; clinical protocol development, implementation, and study management; and support for mechanistic studies. The latter includes 1) biospecimen tracking and establishment and maintenance of a biospecimen tracking database, and 2) assembly and shipping of assay kits and/or bulk supplies that include biospecimen labeling packets (kitting). The T-SCCC will be expected to support approximately 40 active clinical trials, which may be in development, enrolling, in follow-up, or in analysis and manuscript preparation. Most of the trials in the transplant portfolio are conducted under Investigational New Drug(IND) applications or Investigational Device Exemptions (IDE). Target accrual ranges from 10 to several hundred participants, and study duration ranges from approximately three to seven years. In addition to the clinical aspects of the trial, all trials, whether interventional or observational, include in-depth studies of immunologic mechanisms utilizing a range of state-of the-art laboratory technologies and requiring extensive data and specimen collection and sophisticated statistical analysis approaches.

Details of specific current research studies to be supported by the T-SCCC can be found here. The list of research studies to be supported by the T-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.

Structure

Study Statistical Design and Analysis

The T-SCCC will assist in the preparation and review of study designs for clinical research trials or studies by participating in protocol team development calls. Specific activities include:

Study Statistical Design

• Reviewing and offering comments on proposed study designs including but not limited to;
• Ensuring measurability and validity of endpoints and consistency among objectives, endpoints, and study design elements;
• Assisting in the design of/statistical justifications for stopping rules;
• Providing strategies to address challenges frequently encountered in transplantation trials, including but not limited to small sample size, high-risk participants, and unpredictable timelines; and,
• Assisting in the preparation of protocol amendments and ensuring that the statistical integrity of the trial is preserved when there are protocol amendments.

Statistical Analysis

• Preparing interim and final statistical analysis plans (SAPs) for all clinical trials and studies, updating as needed through the life of the study, and implementing the analysis once the database is locked;
• Performing additional analyses as needed through the life of the study, e.g., to evaluate trial/ safety thresholds or unanticipated events, in response to requests from the DSMB, and to assist in preparation of manuscripts and presentations;
• Reviewing the accuracy and completeness of statistical data presented in abstracts, manuscripts, and presentations;
• Providing statistical assistance in connection with regulatory requirements and activities for clinical trials conducted under Investigational New Drug Applications (INDs), e.g., preparation of materials and oral presentations on statistical design and analysis plans for discussions with, and in response to inquiries from, the U.S. Food and Drug Administration (FDA) and other Regulatory Health Authorities;
• Preparing regular statistical reports such as periodic study status reports, DSMB reports, mechanistic specimen reports and components of Interim and Final Clinical Study Reports, and preparing information for ClinicalTrials.gov results reporting requirements;
• Assisting in preparing materials for, and make oral presentations at, DSMB meetings/teleconferences regarding interim and final safety data; and,
• Participating in preparing scientific abstracts, journal articles, presentations, manuscripts, and reports for publication and presentation.

Study Management

The T-SCCC manages, coordinates, and monitors the initiation, implementation, conduct and closure of clinical trials and studies, including:

• Participating in the development of Data and Safety Monitoring Plans (DSMPs);
• Assigning T-SCCC staff to Study Management Teams (SMTs) for each clinical trial/study to collaborate with Protocol Chairs and NIAID staff;
• Developing materials/data for SMT meetings and teleconferences;
• Conducting regular reviews of active clinical trials to assess multiple performance factors, to include, but not limited to subject accrual and retention, and adherence to protocol-specific requirements;
• Documenting action items, problems and deficiencies, and recommending improvements; and,
• Assisting in preparing and presenting status reports on specific clinical trials/studies to consortium Steering Committees.

Support for CTOT-CA and IICT Mechanistic Studies

Provision of Materials for Laboratory Testing

The T-SCCC will provide supplies; prepare, package, and ship kits and bulk supplies; ensure intact receipt; and maintain a computerized inventory of all materials available and distributed. Kits will include the materials to collect and store biospecimens (e.g., blood collection tubes, sterile collection cups, pathology slide cartridges, and cryovials). Bulk supplies will include materials to perform sample isolation, storage, and shipment (e.g., media, reagents, pipets, cryovial storage boxes, vacutainer storage boxes, and biospecimen shipping containers for ambient, refrigerated, and frozen shipments).

Biospecimen Labeling, Shipping, and Tracking

The T-SCCC is responsible for providing for 1) biospecimen labeling for the purpose of tracking the collection, storage, shipping, inventory, and final disposition of all biospecimens collected; 2) domestic and international shipping of biospecimens between NIAID supported clinical sites, laboratories and repositories; and 3) creating and maintaining a database for tracking, reporting, and reconciliation of specimen collection, processing, shipping, and receipt, as well as final specimen disposition.

Data Access, Storage, and Analysis

The T-SCCC will work cooperatively with the CDSMC, which maintains the clinical databases, to obtain datasets for statistical analysis. The T-SCCC will (1) establish standard data interfaces for receipt of clinical datasets from the CDSMC, (2) establish and support statistical analysis software needed to implement the statistical analysis of clinical trial data received from the CDSMC, and (3) collaborate in cross-study and cross-network analyses.

Clinical Research Support Resources Provided by NIAID

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 T-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 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 T-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 T-SCCC will collaborate with ImmPort and CDSMC with respect to 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

Investigators interested in additional related FOAs are referred to the NIAID Clinical Data and Safety Management Center (CDSMC) and the Asthma and Allergy Statistical and Clinical Coordinating Center (AA-SCCC)FOAs.

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:

Tara Capece, PhD, MPH
Telephone: 301-761-7854
Email: Tara.capece@nih.gov

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:

Other Attachments:

Transition Plan

The Transition Plan attachment 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 lacking the transition plan are incomplete and will not be reviewed.

Initial Transition Plan

Currently, the functions of the T-SCCC are incorporated in an ongoing award that also supports similar functions for other NIAID scientific domains (Allergy). Include an Initial Transition Plan that describes the plans, procedures, and timelines to ensure an orderly, secure, and efficient initial transition of all transplantation study related materials, data, standard operating procedures, and any other related documents and to assume all T-SCCC study activities. Samples of data and materials to be transitioned include but are not limited to study protocols, analysis datasets, all study related materials, all materials related to safety reporting and site monitoring, and sample tracking.

Final Transition Plan

Include a Final Transition Plan that describes the plans to maintain full operational capacity until the completion date of the grant with the stipulation that Final Transition must be fully completed by the expiration date of the grant. Plans should include coordination and implementation of an orderly, secure, and efficient transition of data, protocol-related documents, standard operating procedures, and other materials to an NIAID supported system. T-SCCC-generated materials and data to be transitioned include all materials necessary for the seamless continuation of the supported research programs, including but not limited to all items listed in the Initial Transition narrative above.

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

In the biosketch, specifically address the PD(s)/PI(s) qualifications required to: lead and manage a Statistical and Clinical Coordinating Center for multi-center trials in a complex structure; manage a diverse staff of scientific, clinical, technical and administrative personnel; and work with government sponsors and government-supported clinical investigators and clinical trial networks, and industry collaborators.

R&R or Modular Budget

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

Include funds in the budget for the PD(s)/PI(s) and three key personnel to travel. For travel purposes, assume two CTOT-CA meetings and three ITN meetings per year. At least two meetings will be in the metropolitan Washington, D.C. region.

The PD/PI will be required to commit not less than 7.2 person months per year to the project.

The following information is provided to assist applicants with their budget requests. Each year, the T-SCCC can plan to support:

Development of one to five new trials varying in size from approximately 10 to up to 600 subjects.

• The duration of individual participation in the trials will vary from one year to more than five years
• The trials will involve novel interventions in a diverse population of pediatric and adult subjects who are candidates for or are undergoing organ transplantation.
• Management of these trials will include weekly or every-other-week meetings (usually virtual) of the study team.
• Each trial will involve two to 20 clinical sites, primarily located in the U.S.
• Each trial will include between two to six mechanistic core laboratories.
• Biospecimen shipments for up to 40 research studies, consisting of approximately 60 clinical centers, will be required, to include approximately 1,000 frozen shipments and 2,000 ambient shipments per year.

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 proposed T-SCCC.

Research Strategy: The Research Strategy should include the following clearly labeled sections:

A. T-SCCC Management and Oversight

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

• Describe the structure of the T-SCCC leadership team and how this structure will ensure adequate management, coordination and oversight of the T-SCCC;
• Describe internal interactions among the T-SCCC personnel (lines of authority) and the processes that will be in place for effective decision making, resolving operational issues/problems, reporting, and for efficient and effective internal communications. Communication plans should also include efficient communications between the T-SCCC and the CDSMC, between the T-SCCC and NIAID Program staff, and between the T-SCCC and other NIAID-funded investigators;
• Describe processes and procedures to ensure the timely and effective implementation of decisions and support functions, track progress and monitor the use and adequacy of allocated resources;
• Provide a detailed staffing plan for the T-SCCC indicating the types of positions (e.g., biostatistician), degree (e.g., doctoral degree) required and role in the T-SCCC, to include all positions (e.g., biostatistics, kitting, shipping). Indicate if individuals are currently available or will be recruited for positions. Discuss how the approach to staffing will incorporate staff with a working understanding of disease pathogenesis and of currently available therapies and prevention strategies, and knowledge of the populations affected. Do not duplicate information in the biosketch;
• Describe plans for ongoing internal training of T-SCCC personnel;
• List recent projects of similar scope indicating for each the elements of support provided, e.g., support for protocol development, statistical design and analysis support, data management systems established and operated, specimen collection kits provided, and tracking of biospecimens from collection to final disposition. In addition, indicate which of the trials/studies involved transplant recipients or other immunocompromised study subjects. Indicate (i) whether each trial or study was interventional (phase I, II, or III) or observational, (ii) whether the trial was conducted under IND or IDE, and (iii) the number of clinical sites and core laboratories participating in the study;
• Discuss areas where important obstacles were met and how they were addressed by the organization; and
• Describe a plan for prioritizing the management of multiple complex clinical research studies.

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

B. Study Statistical Design and Analysis: Statistical Design; Statistical Analysis; Study Management

Provide detailed discussions of the following:

• Statistical design and analysis considerations of particular relevance and importance for the full scope of clinical research in transplantation, including: clinical trials at all phases to evaluate investigational products/approaches to prevent immune-mediated graft rejection and improve long-term graft and patient survival, associated mechanistic studies, observational clinical studies, genetic studies to understand the genetic basis of immune-mediated graft rejection, and studies to identify and validate biomarkers;
• Methodologies considered to be high priority for the statistical design and analysis of the full scope of clinical research in transplantation and the rationale for their selection;
• Common statistical design and analysis problems and difficulties associated with such clinical trials/studies in general and in relation to differences in transplanted organs, tissues and cells and the populations affected;
• Approaches recommended to overcome and/or improve identified problems/difficulties and optimize the yield from experimental strategies including challenges related to small study size, high risk participants, uncertain timelines, and other characteristics of transplantation studies;
• Emerging methodologies for the statistical design and analysis of clinical research and their applicability to this disease area;
• 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;
• Provide proposed plans, procedures and milestones and timelines 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 of protocols and preparation of protocol amendments and ensuring that the statistical integrity of the trial is preserved when there are protocol amendments; developing and refining study designs and statistical analysis plans for clinical trials/studies in collaboration with clinical investigators, immunologists, and NIAID staff; 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 IND or IDE, 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; and,
• Systems for statistical analysis and information technology (IT) that will be used in support of clinical trials and studies, and describe the IT support for central storage, security, analysis, and retrieval of data.

C. Support for Mechanistic Studies (CTOT-CA and IICTs only): Provision of Materials for Laboratory Testing; Biospecimen Labeling; Biospecimen Shipments; Biospecimen Tracking; Data Access, Storage, and Analysis

Provide detailed information on the following:

• Proposed methods for the design, purchase, packaging, and shipping of materials required for protocol-specific, specialized (i.e., core/mechanistic) laboratory tests. Describe

• Proposed methods for an inventory of distributed materials;
• Process of assembly of kits and bulk supplies, including labeling materials and performing quality control;
• Process for clinical sites to order kits and bulk supplies, and the distribution of those materials;
• Process for design and production of trackable biospecimen labels that includes summary of standard operating procedures or work instructions, manufacturer and materials to be used, barcode technology, interaction/linkage with the specimen tracking data base, and a quality management plan;
• Plans for domestic and international shipping (e.g., FedEx) of biospecimens from clinical centers to the core laboratories and/or biorepositories; and,
• Description of the specimen tracking and inventory database management system to be used (e.g., manufacturer name and years of experience using the system, compliance with 21 CRF Part 11).

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.

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 for this FOA:

Do the PDs/PIs and/or key personnel have well documented qualifications to perform the responsibilities proposed including senior (Ph.D.-level or equivalent) statisticians with experience in transplant research and innovative approaches to clinical trial design and analysis?

Is the proposed staffing plan including the mix of expertise and experience well-justified and well-suited to the scope of the T-SCCC biostatistical 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?

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 for this FOA:

Does the organizational structure provide for a well-integrated entity with an effective governance structure and clearly defined processes for decision-making, collaboration, coordination, and communication?

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?

Are specific approaches suitable to transplantation studies and trials described, including overall study design and management of challenges related to small study size, high risk participants, uncertain timelines, and other characteristics of transplantation studies?

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 for this FOA:

Does the applicant organization demonstrate the capability to effectively and efficiently support the full scope of statistical and clinical coordination functions?

Are information security and integrity well addressed?

Are the software and hardware maintenance plans well aligned with the scope and scale of the T-SCCC?

Does the applicant have access to the statistical software and IT systems needed to support NIAID transplant research?

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.

Statistical Design and Analysis

Does the applicant demonstrate an understanding of the statistical design and analysis considerations of particular relevance to transplant research?

Clinical Protocol Development, Implementation, and Study Management

Does the applicant demonstrate experience in:

Coordination of protocol development, initiation, implementation, conduct, and closure of clinical trials and studies enrolling high risk or critically ill patients?

Developing, preparing, and presenting materials to the Data Safety Monitoring Board (DSMB)?

Regulatory requirements/activities associated with the statistical design and analysis of clinical trials conducted under IND or IDE?

Mechanistic Studies Support

Does the application demonstrate a comprehensive understanding of the requirements for kitting and bulk supplies, biospecimen labeling, shipping, and tracking and reconciliation as well as a plan for domestic and international shipment of biospecimens from clinical centers to the core laboratories?

Data Sharing Plan

Are the Data Sharing Plan procedures for sharing, release and access to data appropriate and adequate for access by the broader scientific community?

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) Sharing Model Organisms; and (2) 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 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 OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

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

• Directing the activities of the T-SCCC, including: (i) establishing and implementing processes for decision-making, communication and collaboration; (ii) establishing and implementing processes and systems for tracking the implementation of T-SCCC support functions, identifying problems/deficiencies, and determining the need for and implementing corrective actions; (iii) assessing and allocating resources, reviewing their adequacy, and determining needed adjustments; (iv) establishing and implementing financial management capacity and systems to track and project T-SCCC resources and expenditures; (v) implementing and managing an information system to support day-to-day T-SCCC activities; (vi) establishing and managing collaboration portals for study-specific documents/materials; (vii) reporting to and obtaining input from clinical research program PDs/PIs; and (viii) establishing procedures and metrics for assessing T-SCCC progress and productivity.
• Providing the full scope of statistical and clinical coordination support; ensuring appropriate and effective coordination and collaboration with senior NIAID officials, research program PDs/PIs and clinical investigators, and other NIAID-supported clinical research organizations; and ensuring that the performance of support functions complies with all Federal and, where appropriate, country-specific regulatory requirements and guidelines for the conduct of human subjects research, as well as NIH and NIAID policies and procedures.
• Participating as a member of the CTOT-CA Steering Committee.
• Providing reports to NIAID staff regarding T-SCCC budgetary summaries as requested.
• Transferring study related data in formats compliant with the DAIT CRIS, ImmPort, Clinicaltrials.gov, Trialshare or another NIAID-approved controlled-access data repository. The privacy of study participants must be safeguarded, and confidential and proprietary information must be protected.
• Ensuring that the NIAID Data Sharing Plan is properly implemented and the complete transfer of all study related data before the end of the award.
• Track details of conditions of Informed Consent for use of biospecimens, e.g., consent for genetic studies and consent for future use, and prepare summary reports of consent status upon NIAID's request.
• Ensuring the appropriate training/certification of Center staff designated to T-SCCC statistical and clinical coordination support, and including a list of all training programs and written assessments in the Annual Progress Report.
• Accepting and implementing guidelines proposed by each NIAID clinical network Steering Committee and other network committees
• 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

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

The 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. The NIH Project Scientist will:

• Periodically review data and material generated under the T-SCCC and use this information for the preparation of internal reports on the activities of any study supported by the T-SCCC. Data must be available for external checking against the original source documentation.
• Facilitate collaborations with and provide access to other NIAID-supported research resources and services.
• Review and assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.
• Periodically review the data generated under this award.
• Meet regularly with the T-SCCC leadership through conference/video calls and conducting at least once-a-year site visits
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Ensuring the provision of appropriate information, materials and training regarding NIH and NIAID policies and procedures for the conduct of human subject research.
• Setting and abiding by project milestones for study initiation.

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 T-SCCC, 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, 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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Deborah Hayes, MS
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3496
Email: dhayes@niaid.nih.gov

Tara Capece, PhD, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7854
Email: Tara.capece@nih.gov

Elizabeth Sihombing
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-669-5530
Email: elizabeth.sihombing@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.

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.