It is critical that applicants follow 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 the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to form a Leadership Group for an Infectious Diseases Clinical Research Consortium, hereafter referred to as the Leadership Group (LG), to support the planning and implementation of clinical research that addresses the scientific priorities of NIAID in evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostic and predictive markers, and devices for the treatment and prevention of infectious diseases. A companion FOA solicits Vaccine and Treatment Evaluation Units (VTEUs), which will provide the scientific, administrative expertise and infrastructure to implement the clinical research. Although the scientific focus will be on malaria/neglected tropical diseases, sexually transmitted infections, respiratory infections, and enteric diseases, the LG and VTEUs will work collaboratively to monitor, identify and adjust research priorities based on potential emerging infectious diseases.

For over 50 years, NIAID has supported the Vaccine and Treatment Evaluation Units (VTEUs), which have performed high-quality clinical research under Investigational New Drug (IND) status to evaluate the safety and efficacy of vaccines and other countermeasures for infectious diseases. Moving forward, the VTEUs will work in tandem with the LG to enhance integration and efficiency in operations, increase collaborations, review and prioritize concepts, plan for protocol implementation, and evaluate ongoing studies. Together, the LG and VTEU programs will foster collaborative team science approaches to address NIAID priorities, such as universal influenza vaccination. Moreover, the LG will assemble Expert Working Groups from specific infectious diseases areas who will prioritize the clinical research to be implemented using their expertise and the current public health environment as reference.

For this FOA, NIAID scientific priority areas include clinical research and Phase I-IV clinical trials for vaccines and other biologics, therapeutics, diagnostics and devices targeting a wide array of infectious diseases, including newly emerging infectious diseases. The LG will collaborate with NIAID to identify and implement clinical research studies and clinical trials that will impact the prevention, diagnosis and treatment of a wide array of infectious diseases. The highest priority for clinical research will be the top infectious disease(s) threats identified by US and international expert bodies, such as the Centers for Disease Control and Prevention and the World Health Organization. A unique feature of the LG is the formation of multiple scientific working groups to provide expert input on the priority research foci of NIAID, such as:

• Malaria/neglected tropical diseases
• Sexually transmitted infections
• Respiratory infections, particularly influenza
• Enteric diseases
• Emerging infectious diseases and other infectious disease considerations

Examples of research activities within the priority research areas include, but are not limited to:

• Evaluation of vaccine and therapeutic candidates
• Pharmacokinetic assessments in Phase 1 first-in-human studies and population pharmacokinetic studies
• Evaluation of sexually transmitted infection diagnostic tools
• Controlled human infection models
• Rapid response to future disease outbreaks, (for example, emerging diseases: e.g. Ebola, chikungunya, and Zika)
• Isolation and characterization of circulating pathogens
• Evaluating reagents and tools for newly emerging diseases

The LG is organized to capitalize on the multiple elements of the program to address current research priorities and develop capacity to respond rapidly to newly emerging disease threats. The structure of the LG includes a Leadership Operations Center (LOC), a Clinical Operations Unit (COU), a Laboratory Operations Unit (LOU), a Statistical Support Unit (SSU) and the Expert Working Groups (EWG). The activities and synergies of the LG will support the large-scale, complex Infectious Diseases Clinical Research Consortium (IDCRC), composed of the LG, VTEUs, NIAID, and NIAID-supported research resources. Collectively, the IDCRC will carry out the clinical research priorities of NIAID.

Applications must contain the following LG Program Elements: Leadership Operations Center (LOC), Clinical Operations Unit (COU), Laboratory Operations Unit (LOU), Statistical Support Unit (SSU), in addition to an application Overview. Applications lacking one or more LG Program Element will be considered incomplete and will not be reviewed.

Leadership Operations Center (LOC)

The LOC will be responsible for overall administrative leadership for the LG, as well as oversight and evaluation of all LG activities, including refining the research agenda, prioritizing research concepts, and ensuring timely publication and communication of results. The LOC is also responsible for the following:

• Governance. Integral to the success of the LOC is establishing clear governance structures, including effective communication and decision-making plans, lines of authority, plans for coordinating and collaborating effectively with external collaborators and NIAID, and resource distribution policies. The LOC may establish internal committees to achieve the work of the LG.
• Research Priorities. The LOC works closely with NIAID Program Staff to ensure the research agenda is consistent with NIAID’s infectious diseases research priorities. The LOC will involve the Expert Working Groups in the prioritization and implementation of the NIAID infectious diseases clinical research agenda.
• Innovation. The LOC explores innovative types of infectious disease countermeasures, study/trial designs, approaches to public-private partnerships, and statistical techniques that will have a broad impact on infectious diseases clinical research.
• Mentoring. The LOC identifies clinical research experience opportunities for junior investigators. This may take the form of small clinical research projects, classroom training in clinical research and statistical analysis, participation in LG committees, participation as junior investigators on studies and trials, and exposure to other aspects of clinical research on infectious diseases.
• Monitoring and Evaluation. The LOC develops and incorporates policies, methods and approaches for monitoring implementation of clinical research conducted by the VTEUs and evaluates the operational performance of the overall LG and each element within the LG.
• Quality Management. The LOC develops strategies for assuring quality management, to ensure that risk assessment and mitigation strategies are an integral part of all research activities within the LG. These strategies will complement quality management systems and processes established by NIAID.
• Collaborative Responsibilities. The LOC seeks out opportunities for collaboration with other NIH-supported clinical networks, and other Federal and private sector clinical research programs. Such collaborations and interactions are essential for the development and implementation of a comprehensive research agenda that utilizes the strengths, experience and expertise of the various collaborating organizations. Sharing of expertise, resources and procedures is expected in key areas, including: harmonization of laboratory resources and specimen management and harmonization of common data elements and data entry interfaces.
• Expert Working Groups (EWG). Multiple groups of scientific experts with expertise in discrete areas of infectious diseases research serve on area-specific working groups to provide advice and recommendations to the LG. The LG will use this information to monitor and prioritize clinical research undertaken by the LG as a function of public health relevancy and need. Areas of working group expertise might include, for example, clinical trial design, vaccine evaluation, immunology, pharmacokinetics, and leadership in priority scientific fields. In addition, experts may be included in specific targeted populations such as pediatrics, geriatrics, maternal/fetal health, etc., and international experts knowledgeable in the field of study and the location of study execution based on geographical reference. In the event of a public health emergency, ad hoc expert working groups could be formed to address specific scientific expertise to assist with protocol development and implementation. The working groups develop protocol synopses outlining the key aspects of planned protocols, review and prioritize concepts for clinical research proposed by the LOC, and plan for clinical research implementation by the VTEUs. The expectations are that working groups are constituted and prepare protocol synopses within the first six months of award. Note: The working groups are expected to consist of VTEU PD(s)/PI(s) or their designees and other experts who are recognized leaders in their specific scientific fields. Working group(s) members should not be named or recruited prior to award.

Clinical Operations Unit (COU)

The COU provides operational support, management, and oversight for the LG’s clinical research. This requires close coordination with the various units within the LG, the VTEUs as the research implementation sites, NIAID staff, and NIAID-provided research support programs. The COU provides leadership on protocol development and implementation planning and is responsible for site selection, qualification, and management of protocol-specific sites. A major activity of the COU will be the establishment of efficient processes for identifying, qualifying, and approving protocol-specific sites to address specific clinical research needs. The COU manages and oversees protocol teams for all LG activities, and establishes efficient systems for resource distribution and reallocation in response to evolving priorities identified by the LOC. Finally, the COU provides specialized training for clinical trials, applicable laboratory procedures and data management for LG staff in support of LG activities. The COU is responsible for the following activities:

• Management. The COU manages, oversees and coordinates long-term and day-to-day activities associated with LG clinical research, including, for example: development of project plans and establishment of realistic milestones and timelines; ongoing evaluation and adjustments to timelines; and implementation of contingency plans. The COU develops standard operating procedures (SOPs), budgets, and communication plans.
• Protocol Development. The COU coordinates activities required to advance protocol synopses through to full protocols and prepares additional protocol-specific documents (e.g. Manual of Procedures (MOP), Statistical Analysis Plans (SAP), etc.).
• Budget Development. The COU prepares budgets for protocol implementation.
• Clinical sites. The COU works with the VTEUs and NIAID to identify the optimal balance of sites for implementation of the clinical research, based on the diverse nature of LG clinical research needs and required patient populations. The COU will evaluate study and trial conduct at the clinical sites. The LG clinical research may be implemented at performance sites within the VTEUs or subcontracted to protocol-specific domestic or international clinical sites by the LG. The VTEUs are considered the fixed sites funded through cooperative agreements with NIAID for continuous operation in implementing clinical research developed through LG activities. At times of specific need, the LG will need to identify and incorporate protocol-specific sites to meet goals or recruitment needs of the supported research. Protocol specific sites are clinical research sites opened for capacity to implement specific protocols when eligibility criteria cannot be met by fixed sites alone, or when surge capacity is required to respond in a high priority research area.

Laboratory Operations Unit (LOU)

The LOU leads the development, implementation and evaluation of the laboratory research that is essential to the successful execution of the LG research agenda. The LOU manages and oversees relevant laboratory services, including any necessary pharmacokinetics (PK) services, bioanalyses, and specimen characterization; laboratory quality management programs; the monitoring and evaluation of all specialized laboratories under the purview of the LG; sharing of specimens outside the LG, as necessary; and providing adequate storage facilities necessary to accomplish the LG’s clinical research agenda. The LOU leadership fosters collaboration and harmonization of laboratory activities within the LG and the VTEU-identified laboratories.

Statistical Support Unit (SSU)

• For trials under a NIAID held IND, the SSU provides: leadership and services for biostatistics, study design, interpretation and publication of results. This includes performing the role of blinded (masked) biostatistician with regard to Safety Monitoring Committees (SMC) and Data and Safety Monitoring Boards (DSMB) activities in randomized controlled trials with blinded (masked) data, assisting NIAID and NIAID-sponsored programs in responding to regulatory inquiries regarding clinical trial design and may include analysis during a study. The SSU collaborates with other NIAID-sponsored programs as necessary.
• For non NIAID held IND trials, the SSU provides: leadership, services and oversight for biostatistics, study design, analysis, interpretation and publication of results, clinical and laboratory data management systems compliant with all current applicable Federal regulations (https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl ) and globally accepted standards, such as: International Council on Harmonization (ICH) E2, E3, E6, M5, MedDRA Terminology (http://www.ich.org/products/guidelines.html); World Health Organization Drug Dictionary (http://apps.who.int/medicinedocs/en/d/Js4953e/4.html; and Clinical Data Interchange Standards Consortium (CDISC) (https://www.cdisc.org/). The systems should be capable of interfacing with other systems. The SSU collaborates with other NIAID sponsored programs as necessary and provides systems training.
• For non-IND trials, the SSU provides: leadership, services and oversight for biostatistics, study design, analysis, interpretation, and publication of results, clinical and laboratory data management systems, to include randomization, and training to ensure accurate, complete, and high-quality data. The systems should be capable of interfacing with other systems.
• The SSU is responsible for standardizing and harmonizing statistics and data management activities, as applicable, within the IDCRC and coordinating with other NIAID sponsored programs as necessary.

Additional resources provided by NIAID:

• Safety Oversight Committees. NIAID oversees the safety of all participants in clinical trials funded by NIAID. NIAID monitors Phase II, Phase III and Phase IV multicenter, randomized clinical trials primarily through DSMBs. NIAID monitors Phase I and small Phase II clinical trials primarily through SMCs in conjunction with Independent Safety Monitors (ISMs) (see https://www.niaid.nih.gov/research/safety-oversight-clinical-research). For the LG, NIAID will provide access to the services needed to provide clinical trials oversight.
• Other Support Services. Responsibility for Investigational New Drug (IND) sponsorship will be determined on a case-by-case basis and may rest with either the Program Directors (PDs)/Principal Investigators (PIs) or with NIAID -- NIAID will make this determination. NIAID will provide additional support services for LG trials that must be conducted under an IND or Investigational Device Exemption (IDE). These services may include: domestic regulatory sponsorship (Regulatory Support Contract), data management and statistical support (SDCC), management of clinical agents and specimens (Clinical Material Services Contract, and clinical site monitoring (Clinical Research Operations and Management Support Contract). Each study will be evaluated for the need for an IND/IDE by NIAID and support services to be provided will be determined on an individual study basis. For clinical trials that do not require an IND/IDE, the LG will provide all support services other than safety oversight. For clinical studies that do not meet the NIH definition of a clinical trial, the LG will provide all resources and expertise necessary for the conduct of the study.
• NIAID will provide a variety of training activities to appropriate LG personnel to help the LG ensure that consistent standards for protection of human subjects and clinical trial conduct and documentation are achieved across the NIAID-supported clinical trials networks. Training areas include, but are not limited to: regulatory requirements, GCP, adverse event reporting, human subject protections, informed consent, and NIAID and NIH policies and procedures.

Annual Program Meetings

The PD(s)/PI(s) of the LG, collaborators, and key personnel are expected to participate in annual program meetings and may be held in conjunction with the VTEU annual program meeting. These meetings provide a forum for program and progress updates, and the sharing of ideas, procedures, and research outcomes.

This FOA solicits applications for the Leadership Group for the Infectious Diseases Clinical Research Consortium. A companion FOA solicits applications for RFA-AI-18-046, the Vaccine and Treatment Evaluation Units (VTEUs).

Note: For further information, please visit the following website for general information and questions and answers.

https://www.niaid.nih.gov/research/future-infectious-disease-research/questions-answers

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

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

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

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

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. This means that the NIH will not accept:

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

Buttons to access the online ASSIST system or to download application forms 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.

It is critical that applicants follow 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.

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

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

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

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

The letter of intent should be sent to:

Annie Walker-Abbey, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3390
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 requirements:

The Research Strategy must consist of the following sub-sections with the indicated page limits:

Subsection A. Overview of the proposed Leadership Group for an Infectious Diseases Clinical Research Consortium one required - 6 pages

Subsection B: Leadership Operations Center one required 30 pages

Subsection C: Clinical Operations Unit one required - 30 pages

Subsection D: Laboratory Operations Unit one required - 12 pages

Subsection E: Statistical Support Unit one required - 12 pages

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

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

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

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

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

Describe the leadership team of the LG, including the PD(s)/PI(s), key personnel and collaborators, in terms of previous experience with implementation, oversight, and overall management of a complex project of this scope. Expand on the specific skills of the PD/PI that will contribute to the success of collaborative and synergistic activities.

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

Beginning in Year 01, requested budgets must include funds for travel by the PD(s)/PI(s), key personnel, and members of the Expert Working Groups to annual meetings in the Bethesda, MD area for 1.5 days to update NIAID on progress and future directions and for travel to protocol specific sites for site assessment or training.

In the budget section, applicants should request funds to support the infrastructure and operations of the LG (Core Funds - CF) under the heading Core Funds. Applicants should not request funds for the implementation of protocols (Protocol Funds - PF) in response to this FOA. Instead PF will be determined and provided to the LG and VTEUs as protocols are approved for implementation through a collaborative process among the IDCRC, LG, VTEUs and NIAID.

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: Describe the specific aims of the LG with respect to the scientific and clinical requirements identified by NIAID, with an emphasis on malaria/neglected tropical diseases, sexually transmitted infections, respiratory infections, enteric diseases, and emerging infectious diseases.

Research Strategy: The Research Strategy section must consist of a single attachment consisting of subsections A-E, as designated below.

Subsection A. Overview

Describe the overall structure of the LG, including all functions that support the execution of the clinical research. Describe the major goals of the LG from a high-level perspective and demonstrate how the individual functional components are relevant to support the research. Provide an organizational chart that includes lines of authority, communications reporting channels, and direction of oversight. As part of this overview, describe how the selected team leadership contributes to the overall success of the program (without repeating the information from the biosketches).

Subsection B. Leadership Operations Center (LOC)

In this subsection, describe the organization of the LOC and discuss how the structure promotes effective leadership of overall LOC activities, including establishing the research agenda that addresses DMID/NIAID’s clinical research priorities. Include the following:

• LOC Structure and Governance:
• Discuss the overall LOC structure, including integration of the clinical operations, laboratory management and statistical/data coordination components. Tables, diagrams, flow charts and organizational charts are strongly recommended.
• Describe the approach to governance of the LOC, including establishment of internal committees and their composition, roles, responsibilities and decision-making authorities. Do not name potential committee members that are not already key personnel in the application.
• Describe the lines of authority and decision-making processes by which the day-to-day operations of the LOC will be managed.
• Discuss how the proposed governance structure capitalizes on the individual strengths of the key personnel to achieve the scientific goals of the LG.
• Discuss plans, including frequency, of the LOC to meet to share scientific and programmatic information, to assess scientific progress, and to identify new research opportunities and potential avenues of collaboration, both within the LOC, as well as the VTEUs and other stakeholders.
• Describe plans to establish effective project management for high-level scientific and administrative decisions for the LG, including research prioritization, reassessment, and redirection. Include a discussion of the involvement of key stakeholders.
• Describe plans for LOC communications, including communications among and between the LOC, COU, LOU, and SSU, and specifically address how NIAID Program Staff and other stakeholders will be integrated into LOC activities. Describe plans for how abstracts and manuscripts describing LG studies will be prepared and reviewed within the LOC.
• Describe in detail the plans for management and administration of the business and scientific activities and how the composition of staff (e.g. PD/PI, project manager, COU, LOU, SSU leaders, administrative staff etc.) and their responsibilities will coordinate for efficient project management to achieve the scientific goals, timelines, and milestones; redirect efforts; and link to cost-effective management of LG resources. Plans should address innovative scientific or administrative approaches and how they will benefit the LG.
• Describe any established collaborations and provide proposed LG collaboration plans, including plans for collaborating with pharmaceutical and medical device companies and other government-funded programs that will advance the LG research agenda. Do not name potential collaborators that are not already key personnel in the application.
• Describe the plans for: a) soliciting, evaluating, awarding and managing subcontracts; b) assessing subcontractor performance, identifying performance problems and approaches for their remediation; and c) plans for financial management of COU resources.
• LG Research Concepts
• Discuss how the LG will respond and/or redirect the research based on current and future public health needs in terms of rapid implementation of clinical research, e.g. during an evolving epidemic.
• Describe how the concepts for clinical research will be solicited, developed, evaluated, prioritized and assigned to protocol development and implementation, including concepts from outside the LG.
• Describe how the LG will work together with the multiple VTEUs and other stakeholders to select and prioritize approved clinical research concepts into implementation.
• Include the process for considering requests for ancillary studies to ongoing research and the process for prioritizing these requests.
• Describe the role the Expert Working Groups will play in the process of concept development and prioritization. Outline the process for creating and implementing the EWGs in the areas of expertise needed to accomplish the goals of the program and outline the criteria for constructing the correct balance of expertise to accomplish the goals of the EWG. Do not name, contact or recruit any potential members of the EWGs.
• Training
• Describe how the training needs of LG scientific staff will be determined and provided, how the value and effectiveness of training conducted will be reviewed and evaluated periodically, and how necessary changes in training programs/approaches will be decided and implemented.
• Provide plans to incorporate clinical research training opportunities and mentorship for junior clinical investigators into the LG.
• LG Evaluation and Improvement
• Describe how the overall performance of the LG will be evaluated and improved over the course of the award period.
• Describe proposed policies, methods, and approaches for evaluating the operational performance of the overall LG, LOC, COU, LOU and SSU in the conduct of LG activities, including the financial management of LG resources. Include a discussion of metrics that may be used to determine both productivity and quality of the results generated by the LG (including the COU, LOU and SSU) over the duration of the award. Include information on how findings will impact adjustments to LG activities and follow up evaluations.
• Describe metrics that will be used in evaluation of the rapid identification and opening of new sites (including internationally) in the face of a study targeting an emerging infectious disease.
• Describe proposed processes for the resolution of performance problems and proposed processes for the development of remediation/improvement plan at the site level to avoid future shortcomings.
• Describe methods and approaches for monitoring implementation of clinical research conducted by the VTEUs for evaluation of VTEU performance.

Subsection C: Clinical Operations Unit (COU)

Describe the structure and function of the COU in implementing the clinical research of the LG. Include the following:

• COU Structure and Management Plan:
• Describe the organizational structure of the COU, including staffing plans. Include diagrams, organizational charts and visuals of lines of authority, as applicable. Describe how the COU will provide oversight for the clinical research.
• Describe the processes and procedures to establish effective project management of COU activities. Discuss how the work will be divided among the staffing plans to meet clinical research timelines and milestones (with appropriate metrics), develop contingency plans and redirect efforts, as needed, link to cost-effective use of COU resources, and as applicable, solicit, evaluate, and rapidly award subcontracts, and manage subcontractor performance, including in diverse international locations where infectious disease epidemics may emerge.
• Discuss how decisions will be made for setting and adhering to timelines and plans for remediation and follow up for failure to meet established timelines.
• Provide plans for communicating and coordinating with the VTEU clinical sites and laboratories, the protocol specific sites, and NIAID-funded clinical research support programs.
• Include plans for evaluating the operational performance of the protocol teams, clinical sites and affiliated laboratories, and proposed processes for the development of remediation/improvement plans to avoid the identified shortcomings in the future.
• Protocol Development:
• Describe the proposed approach to developing clinical research concepts into protocols and associated documents, ensuring adherence to NIAID clinical research policies and SOPs. Describe how decisions at each step in the protocol development process will be made. Include a discussion of the process for fast tracking development of high priority concepts.
• Provide the criteria upon which protocol investigators, protocol project managers, and protocol teams will be selected and assembled to ensure strong scientific, clinical, and operational leadership. Describe how protocol teams will access expertise in clinical site management, study product management, regulatory support (including for non-US regulatory agencies, where applicable), and industry liaisons, as appropriate.
• Discuss how protocol development management plans will be developed, tracked, and monitored. Include a discussion of establishing realistic milestones and go/no-go criteria, evaluation of established plans, actual data, and future projections. Include discussion of the development of contingency plans and the processes to adjust project plans.
• Discuss the process for developing essential documents to support the protocol, such as regulatory documents, the Manual of Operating Procedures, Standard Operating Procedures, and Informed Consent Forms.
• Discuss how protocol specific budgets will be developed, including cooperation with the VTEUs, to ensure protocol cost-containment and monitoring.
• Describe plans, processes and communication strategies to meet the requirements of sIRB.
• Clinical Site Selection and Interactions:
• Describe the process for conducting feasibility assessments, including how site capacity, capabilities, and needs will be assessed.
• Provide a plan for systematically capturing the type and quantity of VTEU-site specific capabilities to address rapid assessment of VTEU site capabilities to implement clinical research. For example, data on patient populations available at each site (including demographics, sample selection, laboratory capabilities, pharmacy access, etc.) to achieve an accurate assessment of clinical sites.
• Describe the processes for soliciting, reviewing, and selecting protocol-specific clinical sites to implement specific protocols, and rapidly subcontracting to implement protocol-specific sites. Include a discussion of the factors to be considered for utilizing international clinical sites and address issues associated with such sites (e.g., local regulations, etc.) within that plan.
• Protocol Implementation:
• Discuss plans for implementation of approved protocols, including how the COU will identify and ensure adherence to critical milestones and adjustments based on evaluation of projections against actual data. List the expected critical milestones for protocol implementation.
• Describe plans and procedures to identify and provide protocol-specific training. Include the source(s) of training; general format; plans for monitoring training needs; and how the need for retraining will be identified and implemented, if required.
• Describe plans for quality oversight, including tracking protocol deviations, ensure reporting to IRB/IEC, if applicable per policies.

Subsection D: Laboratory Operations Unit (LOU)

Provide an overview of the anticipated scientific contributions of the LOU towards implementing the research agenda of the LG. Include the following:

• Services and Methodologies:
• Describe the organizational structure of the LOU. Include diagrams, organizational charts and visuals of lines of authority, as applicable.
• Describe the types of services to be provided, including plans for development of any new/innovative assays that further the goals of the research agenda.
• Discuss how the selection of specialized assays, procedures (e.g. specimen characterization), and analyses (e.g. PK and other bioanalyses) would be determined for tests from disease-specific protocols.
• Describe processes to determine the nature and type of biological samples to be collected, and how the samples will be processed, labeled, inventoried and stored according to standardized procedures appropriate to sample type until needed. Include plans for shipment tracking.
• Describe the LOU’s approaches for conducting ancillary studies using pre-existing stored samples when available from LG clinical research.
• Describe the LOU’s approach to sharing and distribution of samples, specimens and other laboratory materials outside the LG. Address compliance with applicable laws.
• Describe how the LOU will interact with the VTEU laboratories (individually and as a group) to share assay expertise and harmonize procedures to achieve standardization.
• Quality Management:
• Describe laboratory quality management procedures. Include general quality assurance (QA) and quality control (QC) procedures, as well as LOU requirements for external quality assurance (EQA), validations, reference range studies and laboratory audits.
• Describe the overall quality control procedures for the nature and type of expected biological specimens, and how to identify and resolve issues with quality control to maintain the integrity of specimens.

Subsection E: Statistical Support Unit (SSU)

Provide an overview of the SSU toward implementing the research agenda of the LG and providing statistics and data management support to proposed clinical research. Include the following:

• Organizational Structure:
• Describe the overall SSU structure, including statistics, data management and IT elements. Provide a detailed description of the lines of authority. Include diagrams, organizational charts and detailed descriptions of lines of authority, as applicable.
• Discuss how the composition of the SSU will facilitate the achievement of the goals of the LG in connection with designing and implementing cutting edge statistical analysis and the development, validation and utilization of data systems designed to support research in infectious diseases.
• Discuss how the SSU will interface with the LG program elements including protocol-specific sites, and the VTEUs in terms of, for example, protocol design and development, data analyses, preparation of data summaries (within and across protocols), and publication of results.
• Technical Capabilities:
• Discuss any innovations in design or statistical methodologies that may broadly impact the field of infectious diseases research and improve the ability to study difficult-to-study infections.
• Describe the development of data collection systems, forms and formats, and identify any innovations in adapting database systems and structures to accommodate LG and collaborator needs.
• Describe the process for preparation of materials, forms and manuals for the implementation of clinical research (e.g., Case Report Form (CRF), Laboratory Manual, Pharmacy Manual, eCRF instructions).
• Explain the processes for planning and conducting interim and final analyses (including safety analyses) of clinical research, including the development of Statistical Analysis Plans.
• Describe plans and procedures for strict maintenance of blinding throughout studies.
• Describe procedures used for study randomization, randomization systems supported, procedures for verification and validation of eligibility prior to randomization.
• Data Management Plans and Systems:
• Describe the nature and type of data to be collected, and how these data taken together will address the overall goals and objectives of LG studies. Provide a plan for managing data generated in the context of clinical research proposed by the LG and implemented by the VTEUs.
• Describe plans for the provision of an electronic specimen tracking system. Describe the data system and its components, their individual and integrated functional capabilities, and the method(s), requirements and procedures for compliance with NIAID policies, regulations and procedures. Describe procedures used to guide software selection and modification including project planning, requirements definition, system design, implementation, integration and testing, deployment, maintenance, and system retirement.
• Describe the capability of the data systems to collect and manage data for research of similar scope.
• Describe the processes that will be used to collect and manage data generated at clinical sites, clinical laboratories and central LG laboratories, including a description of how data will be transmitted, collated, reconciled and merged for purposes of efficient and valid analysis. Describe the query generation and resolution process.
• Describe the day-to-day procedures that will be used to ensure data quality and validity, including the processes and proposed timelines for querying and resolving data discrepancies or irregularities or acquiring missing data.
• Describe the SSU policies and plans to ensure the security, confidentiality, and integrity of data and data systems at the SSU and during the transmission of data from and to external systems, including NIAID-supported research support programs.
• Describe measures used to ensure compliance with US regulatory authority and or public laws of data coding activities.
• Describe plans for data retrieval, including timely provision of reports (data sets, tables and figures), and statistical support for LG publications. Indicate how these results will be prioritized.
• Describe plans for training site personnel on the use of data systems, forms, and other documents for collecting data.
• Describe procedures for the timely provision of confidential closed and/or open data sets and presenting data to the Safety Oversight Committee (SOC).
• Describe SSU system capability for electronic data exchange with other NIAID sponsored programs and with other collaborators outside the LG.
• Describe SSU system functionality for real time reports of adverse events, serious adverse events, protocol deviations, enrollment, specimen tracking and inventory management, reports to support clinical site monitoring.

Letters of Support: Attach a file with all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site investigators, units, laboratories, pharmacies, and any industry and academic collaborators. Provide a letter signed by the appropriate institutional official(s) from the applicant institution documenting specifics of institutional commitment for the duration of the potential award. Include a letter from the applicant organization(s) indicating agreement to provide efficient and effective negotiation and execution of subcontracts, and other legal agreements.

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

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

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or 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, with the following instructions:

Although applicants must be prepared for clinical trials, definite plans for such involvement will not be possible at time of application. A Study Record should not be completed.

Delayed Onset Study

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

Note: Applicants must enter at least one delayed onset study record and check the box "Anticipated Clinical Trial?"

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

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.

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.

• Awards issued under this FOA will be incrementally funded awards for project periods of up to seven years. Multi-year funded grants will not be awarded.
• Grants awarded under this FOA will be excluded from automatic carryover all carryover requests must be approved.
• Grants awarded under this FOA will not be provided the authority to automatically extend the final budget period one time for up to 12 months beyond the original expiration date shown in the Notice of Award all extensions, including the first extension, will require approval.
• Progress and financial reporting will be required and reviewed annually.
• All funds must be expended within the approved project period.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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).

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

Does the project address an important problem or a critical barrier to progress in the field? Is 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?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this FOA: Is the overall plan for addressing high priority research projects and key questions in infectious disease research significant and timely? Will the clinical research prioritization methods adequately address current and future public health needs, and address key clinical questions in infectious diseases research? Can site capacity be rapidly expanded if needed during an emerging infectious disease epidemic? Are the LG structure and governance adequate to ensure that the LG continues to respond to the most significant needs and opportunities in infectious diseases clinical research across the duration of the award?

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?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this FOA: Do the PD(s)/PI(s), collaborators and key personnel of each unit have documented experience in directing clinical research projects of comparable size and scope required to address the objectives and scope of the FOA?

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

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this FOA: Will the LG structure allow for optimal innovation in infectious diseases clinical research?

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

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) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed??

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this FOA:

• Leadership Operations Center:
• Are the organizational structure and governance plans for the LOC appropriate to achieve the goals of the LG? Are communications plans within the LG, between the LG and VTEUs, NIAID and stakeholders adequate to maintain a bi-directional flow of information?
• Are there appropriate and feasible procedures to measure and assess the productivity of the LG overall and each unit individually and to adjust, as needed?
• Is the project management plan adequate to monitor and evaluate progress for high-level scientific and administrative decisions for the LG, including research prioritization, reassessment, and redirection? Is there a plan for remediation of units within the LG? Are the plans and approaches for LG improvement appropriate?
• Are the plans to redirect effort across the LG to accommodate public health emergencies or high priority NIAID research appropriate and feasible?
• Are the plans for clinical research concepts developed, evaluated, prioritized and assigned to protocol development and implementation, including concepts from outside, well-described and appropriate to achieve the research priorities of NIAID?
• Are the training plans for new staff training, refresher training and training on data systems appropriate? Are there plans for evaluation and update of the staff training materials?
• Are there plans to incorporate junior investigators in clinical research and does the plan cover a range of needs?
• Clinical Operations Unit:
• Are the organizational structure and staffing plans of the COU appropriate to achieve the goals of the LG?
• Are the management and communication plan adequate to manage, support and track protocol development and implementation, communicate with NIAID, and achieve the goals of the LG?
• Are the COU project management plans appropriate to monitor and track progress of multiple clinical trials? Are the protocol development management plans well-defined, with realistic milestones, and easily tracked, and monitored?
• Are appropriate approaches proposed to identify, select and manage clinical sites, protocol-specific sites, and international sites, if applicable?
• Are the plans adequate for: a) soliciting, evaluating, awarding and managing subcontracts; b) assessing subcontractor performance, identifying performance problems and approaches for their remediation; and c) plans for financial management of LG resources?
• Laboratory Operations Unit:
• Are the plans for identification and integration of multiple laboratories appropriate for the services needed across the LG?
• Are the proposed number, type and location of laboratories adequate and appropriate to meet LG research needs in the case of public health emergencies, surge capacity or NIAID high priority research?
• Are the plans for the assessment and implementation of new assays and technologies appropriate to achieve the goals of the LOU?
• Are the plans for the sharing and distribution of samples, specimens or other laboratory materials appropriate?
• Is the plan for laboratory specimen and data inventory, identification, handling, storage and tracking (for shipments) appropriate?
• Statistical Support Unit:
• Are the plans for providing specific statistical and data management services to the LG adequate to ensure high quality, reliable, and secure data?
• Are plans adequate to provide and prioritize interim and final analyses of clinical research studies, requests for randomization and blinding, and verification of eligibility status throughout the study?
• Are the plans and procedures associated with the electronic data and specimen tracking system sufficient to ensure data quality and integrity, and secure transfer and receipt of data from other data systems, as needed?

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?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Specific to this FOA: Is there evidence, including in the letters of support, of adequate institutional commitment and capacity to provide effective administrative, financial, and managerial support for highly complex clinical research?

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.

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

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.

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.

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR 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:

• Overseeing all aspects of studies supported through this award, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The PD(s)/PI(s) agrees to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of studies supported by this award as stated in these terms and conditions.
• Facilitating and supporting communications and collaborations to achieve goals of LG.
• Adhering to NIAID policy for the conduct of clinical trials, see https://www.niaid.nih.gov/research/dmid-clinical-research-policies.
• Managing involvement of industry or any other third party in studies supported by this award.
• Establishing policies and procedures for decision-making to adapt to evolving research priorities over time and to address emerging public health needs.
• Coordinating, monitoring and advancing the process by which clinical research concepts are solicited, proposed, reviewed and implemented to achieve goals of the LG.
• Establishing and providing by-laws, policies and standard operating procedures to NIAID Program Staff within 90 days of issuance of an award, to include, at a minimum, the following:
• Assure compliance with NIAID Clinical Research Policies and Standard Operating Procedures and to ensure adequate protection of the rights and safety of subjects involved in the research.
• Detailed lines of authority and communication plans within the LG, and among the VTEUs, and NIAID program staff.
• Communication and integration plans with NIAID funded research support programs, including how the SSU will interface with the NIAID-supported Statistical and Data Coordinating Center (SDCC) to provide quality, consistent and timely sharing of LG clinical research data or laboratories with the SDCC and how the SSU will interact with NIAID held safety oversight committees.
• Clinical Quality Management Plan-- developed in accordance with DMID CQMP (https://www.niaid.nih.gov/research/dmid-clinical-quality-management) policy and to be approved by DMID.
• Coordinate and collaborate with NIAID and NIAID clinical research support programs to facilitate collection of site essential regulatory documents, activation of study sites, clinical site monitoring and quality assurance services, pharmacovigilance (Serious Adverse Events [SAE] reporting) and safety oversight, in adherence with NIAID standards and processes.
• Ensuring participation in reliance agreements to meet sIRB requirements.
• Providing a protocol to NIAID Program Staff for each clinical research study prior to study start.
• Identifying, qualifying, and approving protocol-specific sites to address specific LG research priorities after award.
• Ensuring the following are provided to NIAID Program Staff for each clinical trial:
• Project Management and communication plans.
• Composition of the study team, including roles and responsibilities.
• Timelines and budgets.
• Recruitment and Retention plan.
• Creating and managing the Expert Working Groups after award and participating in the activities of the Expert Working Groups, as needed.
• Working closely with NIAID Program Staff to ensure the research foci are consistent with NIAID’s infectious diseases clinical research priorities.
• Determine the distribution of core and protocol funds, monitor expenditures and communicate with the clinical research sites, as needed as clinical research is planned.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The NIAID Project Scientist will coordinate the activities listed below. NIAID staff assistance will be provided by an NIAID Program Officer, Clinical Project Manager(s), and Medical Officer(s). These staff will be identified at the time of award.

• Provide specific guidance on expectations for clinical research.
• Ensure that LG research efforts are consistent with NIAID priorities for clinical research and complement other NIH and NIAID programs.
• Facilitate coordination among the NIAID- and NIH-supported clinical trials networks and research groups, clinical research support programs, and other U.S. Government agencies, promoting collaborations and facilitating information exchange.
• Review and accept processes for identifying, qualifying, and approving protocol-specific sites to address specific LG needs after award.
• Serve as members of study teams.
• Track protocol development, implementation, and study conduct.
• Serve on protocol development Teams
• Serve as resources for scientific and policy information.
• Share information regarding promising new agents, strategies, and developments when appropriate.
• Identify scientific gaps and organize meetings to facilitate exchange of scientific and regulatory information, including during LG meetings.
• Periodically conduct an independent review of the constituent parts of the LG for reliability and compliance with clinical and regulatory requirements.
• Coordinate contract resources that facilitate the provision of support services for clinical research.
• Participate on LG-developed working groups as a voting member.
• Participate in the presentation of research results, including publications.
• Implement, monitor, and update the clinical research agenda for the LG to ensure consistency and relevance with NIAID’s infectious diseases research scientific priorities.
• Develop and implement an evaluation and remediation plan to address performance metrics for the IDCRC program elements.
• Under urgent public health situations, the NIAID may re-direct funds or provide additional funds to individual awards to support research of direct relevance to the emergency.
• Clinical Trials Agreements. For trials requiring IND/IDE, NIAID will lead the negotiation of Clinical Trials Agreements (CTAs) with pharmaceutical companies (or other providers of investigational agents). NIAID will provide copies of signed CTAs to the LG.
• Trial Sponsorship. NIAID will have the option to independently file an IND on investigational agents or an IDE on investigational devices evaluated in NIAID-supported clinical research. Responsibility for Investigational New Drug (IND) sponsorship will be determined on a case-by-case basis and may rest with either the PD(s)/PI(s) or with NIAID -- NIAID will make this determination. NIAID will advise the investigators on the specific regulatory requirements for IND/IDE sponsorship. In situations where NIAID is the IND sponsor, NIAID through its contractors will also assemble, review, and submit the required regulatory documents to the FDA. When holding an IND or IDE, NIAID has responsibility for the data management and reporting of safety information in accordance with FDA requirements and preferences. In order to provide for consistent reporting of serious adverse events across the NIAID-supported clinical trial networks, NIAID will provide current policies and procedures that govern the reporting of adverse events in NIAID-supported trials.
• Pharmaceutical Support. For studies in which NIAID is the IND or IDE sponsor, NIAID staff and/or contractors will provide consultation on study treatment-related issues, including manufacturing, preparation, administration and availability of active dosage forms and placebo. NIAID staff and/or contractors may also interact with pharmaceutical company collaborators to facilitate adequate and timely supply of study product; and oversee the distribution of study product to the VTEU pharmacies and/or clinical sites.
• Trial Monitoring. NIAID will oversee an external clinical site monitoring contract that evaluates GCP, regulatory compliance, protocol implementation, internal quality assurance, and study product accountability at the clinical sites for clinical trials conducted under IND/IDE. The trial monitoring contractor, with or without accompanying NIAID staff, will visit the clinical sites periodically to review selected protocols, provide training on general protocol conduct, review internal QA/QC plans, and audit pharmacies.
• Laboratory Oversight. NIAID staff and NIAID contract resources will provide oversight and monitoring of clinical sites for GCLP and for the quality of subject diagnosis and safety tests (e.g. hematology, chemistry, liver function), as well as the quality of pharmacological tests (e.g. drug levels, drug interactions), end point tests and blood processing.
• Concept and Protocol Approval. NIAID will review all concepts and protocols and must approve all clinical trial protocols before implementation. The Clinical Project Manager or designee will return comments and recommendations on concepts and protocols to the LG after review. The LG must address in writing all safety, regulatory, ethical, and conflict of interest concerns raised by NIAID to the satisfaction of NIAID before participant enrollment can begin under a protocol. If a protocol is disapproved, NIAID will not provide investigational products or permit expenditure of NIH funds for the proposed investigation. If a protocol is not initiated within twelve months of NIAID approval, re-review and approval by NIAID will be required.
• Safety Monitoring. NIAID will oversee an external contract that will develop appropriate safety monitoring plans for all planned clinical trials. NIAID must approve the plan for all trials involving investigational drugs, devices, or biologics. The frequency and intensity of safety monitoring will be based on individual study characteristics and experience with study products and may require review by an Independent Safety Monitor, Safety Monitoring Committee (SMC) or Data and Safety Monitoring Board (DSMB). NIAID Medical Monitors will be part of protocol safety review teams to monitor the safety and efficacy of the intervention(s) for ongoing studies and will be provided with appropriate reports. Medical Monitors will be responsible for the disposition of Serious Adverse Events. Approval of the final monitoring plan, including the composition of the review committee, by NIAID is required prior to study initiation. NIAID independently supports Data and Safety Monitoring Boards (DSMB) that oversee Phase IIb/III and other select clinical trials at the discretion of NIAID.
• Study Termination. NIAID reserves the right to terminate or curtail clinical research for any of the following reasons, but cause for termination is not limited to the items below:
• Risk to subject safety.
• The scientific question is no longer relevant, or the objectives will not be met (i.e. slow accrual).
• Occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity.
• Risks that cannot be adequately quantified.
• Ethical concerns raised by the community or medical care/health care authorities.
• Failure to remedy deficiencies identified through site monitoring.
• Substandard data.
• Reaching a major study endpoint substantially before schedule with persuasive statistical significance.
• 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.

Data Access. The awardees retain the rights to the data, consistent with current DHHS, PHS, NIH and NIAID policies; however, NIH will have access to all data generated (raw and analyzed) and may periodically review it. This includes a review of data as recorded on the case report forms or in the central database, and external checking against the original source documentation as required by federal regulation and NIAID as the IND/IDE sponsor. NIAID may request from the IDCRC specific data analysis needed for programmatic activities or for issues related to NIAID plans with other partners. The NIH may provide public access to selected data sets generated with the use of public funds within a reasonable time after primary analysis and publication. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

Areas of Joint Responsibility include:

• Reviewing the LG research activities and goals on an agreed upon schedule (but no less than once every year).
• On an ongoing basis, the LG, VTEU and NIAID staff will jointly evaluate the progress of clinical trials, including enrollment milestones, site quality, and data quality. NIAID and NIAID-supported resource contractors may audit sites, LG SSU, and laboratories to assess GCP and data quality and integrity.
• On an ongoing basis, assess the performance of the LG, the units of the LG and the protocol-specific sites. Protocol specific sites that fail to meet performance standards may be subject to withdrawal of funding.

Dispute Resolution:

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

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

A final 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.

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

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.

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

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Seema Nayak, M.D.
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Annie Walker-Abbey, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3390
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Julie Bergerud
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2967
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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.