NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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 FOA is to establish multidisciplinary research Centers that focus on the development of novel, in vitro human tissue model systems that can advance understanding of infectious diseases through overcoming longstanding obstacles that inhibit basic and translational research. Each Center will include investigators with appropriate expertise in infectious diseases, human tissue engineering, and the human microbiome, where relevant, to develop innovative models that recapitulate pathophysiology and host response, and provide relevant predictive outcomes for human diseases.

This program will address longstanding scientific obstacles through integrating advances in tissue engineering with the needs of infectious disease research. For this particular announcement, the following statement should be used as the conceptual basis for the use of the term tissue engineering": "Tissue engineering brings together the knowledge of cells, cellular environment and materials, and this can be coupled with biochemical cues to replicate tissues and their functions (paraphrased from the Journal of Tissue Engineering.) Many infectious diseases have no or inadequate corresponding animal models; some human pathogens do not infect any other vertebrate animal species, and many animal infections do not mimic the human disease. A critical issue for therapeutic and vaccine development is that preclinical studies performed in animals frequently do not predict the outcome of the human clinical trial. Thus, better predictors of toxicity and efficacy, along with better predictors for host-targeted therapies, are urgently needed. Furthermore, current in vitro culture systems have inherent limitations; they lack a tissue-like environment, do not replicate the pathologic effects of human disease, and do not adequately reflect the host response. Moreover, there are human pathogens that cannot be cultured routinely in the laboratory, which has stymied the development of genetic tools.

Significant advances in tissue engineering and regenerative medicine, coupled with vital knowledge about the human microbiome, provide a powerful opportunity for development of novel human tissue models to address complex, unresolved problems in infectious diseases research. An NIAID/DMID workshop In vitro Tissue Models for Infectious Diseases, convened in 2013, yielded a report that outlined obstacles to advancing basic and applied research in infectious diseases and identified bioengineering methods that could be applied to overcome these impediments.

This program is designed to foster partnerships between appropriate experts (e.g., tissue engineers, microbiologists, infectious disease specialists, immunologists or pathologists) with the objective of developing improved three-dimensional (3D) human tissue models for infectious diseases research and, as a long term goal, models to facilitate the development of vaccines and therapeutics.

The objective of this FOA is to establish a program of Centers focused on development of advanced human tissue models for infectious diseases research and related activities. Each Center will comprise researchers with expertise in tissue engineering technologies, infectious diseases, and the microbiome to develop in vitro model(s) that mimic biological structures, recapitulate human physiology and disease pathology, and incorporate components critical to disease and human host response. The intent is that the proposed model(s) will facilitate basic and translational research with long term potential to extend to related product development.

The focus of a Center may vary; it might be a given human tissue, a class of microbial pathogens, or a combination of the two. Models of interest might range from constructs that incorporate immune components and/or microbiota to mimic the human respiratory tract to model systems that simulate the human circulatory or lymphatic systems. For pathogens that have no relevant non-human vertebrate animal model, a long term goal is to have model systems that can be used in IND-enabling studies.

Thus, responsive applications would include development of the model system (e.g., organ-like structures or biomechanical devices that incorporate key aspects of pathophysiology), implementation to demonstrate feasibility, and application of the model to address key questions for infectious diseases that range from basic science to preclinical studies. The use of clinical samples (e.g., bacterial isolates, human tissues, human blood, immune components, and stem cells) in these studies will reinforce the pertinence to human disease. Importantly, technologies must be developed with the end use in mind, i.e., sufficiently simple for routine use in infectious disease laboratories or adequately robust for use in preclinical studies.

Desired model characteristics may include, but are not limited to the following:

• Three-dimensional models that include relevant anatomical and cellular elements
• Inclusion of immune elements (e.g., macrophages, neutrophils, or mucosa-associated lymphoid tissue)
• Inclusion of site-specific microbiota, where appropriate
• Accurate reflection of human host - pathogen interactions
• Capacity to test vaccines or therapeutics with models that mimic the human host
• Markers or readouts to confirm that the model(s) of interest mimic human disease
• Methodologies to accommodate non-cultivable pathogens, where applicable

• Pathogens: Applicants are encouraged to develop tissue models that are relevant to two or more human pathogens.
• Cells: The use of transformed or immortalized cell lines is discouraged, except for preliminary, proof of concept studies. The use of primary cells, organ explants, or pluripotent stem cells, e.g., induced pluripotent stem cells, is encouraged. Multipotent or unipotent stem cells also may be utilized where appropriate. The current NIH guidance on stem cell usage can be found at http://stemcells.nih.gov/policy/pages/2009guidelines.aspx.
• Biomaterials: Native extracellular matrices (ECM) are dynamic, complex microenvironments that can drive functional and biomechanical development. Applicants should consider the biological properties and potential downstream effects when choosing ECM materials.
• Materials should be chosen to avoid confounding characteristics, e.g., the plastic polydimethylsiloxane (PDMS) binds hydrophobic drugs or reagents, which decreases the intended concentration, and can leach the endocrine disruptor cyclosilane into the medium.
• Collaborative Interactions: Model system(s) development will require extensive collaboration; thus, in depth communication between the infectious diseases and tissue engineering/tissue biology experts is imperative.
• Preliminary Data: Collaborative efforts between the Tissue Engineering and Infectious Diseases Community represent a new scientific area for these communities; thus, substantial preliminary data will not be required but sufficient information should be supplied to establish feasibility.

• Development of tissue models for prions
• Development of animal models
• Development of tissue models for HIV/AIDS
• Clinical trials: For questions concerning the conduct of clinical studies under this FOA, applicants are encouraged to communicate with the Scientific/Research Contact.
• A clinical trial is defined by NIH as: A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

Applications proposing projects focused on the areas above will be deemed non-responsive and will not be reviewed.

Each application in response to this FOA must include: (1) an Administrative Core; and (2) two or more Research Projects. In addition, the application may include optional, shared Scientific or Resources Cores that support the work within the Human Tissue Models for Infectious Diseases Cooperative Research Center (HTMID CRC).

Each Center in the HTMID CRC program must establish and manage a multidisciplinary research program focused on development of a specific human tissue model(s) for infectious disease(s). Each Center will comprise a team of researchers with demonstrated expertise in infectious diseases and tissue engineering/biology as well as applicable expertise in immunology, microbiome biology, biomedical imaging, and/or assay development that is crucial for the development and utilization of the proposed tissue model(s).

Administrative Core (Required)

The Administrative Core is responsible for guiding the overall activities of the Center. Center Directors may consider the utility of assembling a panel of external scientific consultants who can review and provide recommendations on the Center’s performance and progress towards the overall goal.

Pilot Developmental Research Projects

Each Center should identify and support Pilot Developmental Research Projects (DRPs) that take advantage of novel technologies and new opportunities in infectious diseases research. These projects may provide an opportunity to expand on basic science hypotheses, enable testing of novel ideas, develop new technologies, or provide further training in certain areas under investigation by the Center. Each Center is limited to supporting no more than two DRPs per year, although the total number of DRPs that a Center can support during the entire award project period is left to the discretion of each Center.

Pilot Developmental Research Projects are not intended for pre-doctoral candidates, but may include researchers new to the scientific focus of the Center. This program is designed to provide research opportunities within the approaches, methodologies and resources generated under the Center that can enhance or transition into Research Projects as needed. Descriptions of projects that will be supported by DRP funds are not part of the application; the projects will be proposed, selected, and approved after award.

Annual Programmatic Meetings

Annual Programmatic Meetings will be held to facilitate communication and collaboration among awarded Centers. Each Center will assume responsibility for organizing at least one 1 to 2 day Annual Programmatic Meeting of all Centers during the award period. These meetings are to be held at a location at/near Bethesda, Maryland or at another agreed-upon site following consultation with NIAID staff.

HTMID CRC Executive Committee (EC)

A Center Executive Committee (EC) will review each Center s pilot DRPs and will provide recommendations to the PD(s)/PI(s) regarding their probability for success. In addition, the EC will facilitate interaction, collaboration, and communication among the Centers and NIAID Program staff. The composition, responsibilities, and meeting/logistical requirements of the EC, whose membership includes the PD(s)/PI(s) from each Center, are detailed in the cooperative agreement terms and conditions of award below.

Research Projects (Required)

Each Center must include at least two thematic Research Projects organized around the chosen theme. These collaborative projects may build on information that is available to the scientific communities and should utilize the latest appropriate technology to discover novel and innovative ways of addressing any scientific obstacles or gaps in knowledge. Projects must propose research with one or more infectious pathogens and are encouraged to incorporate human microbiota where relevant. These projects should advance the overall understanding of human infectious diseases and accelerate translational application through the development of innovative tissue models.

Scientific or Resources Cores (Optional)

Each Center may support Scientific service and/or Resource Cores as necessary to ensure the success of the supported Research Projects and the overall goal(s) of the Center. Scientific or Resource Cores are optional Cores that provide scientific, microbiological, and/or clinical services or resources to Research Project(s). Cores must be well justified and clearly non-duplicative of other services or facilities available to Center investigators. Examples of services that might be provided by a shared Core include tissue construct resources and fabrication, microbiota resources, clinical specimen acquisition, or statistical support.

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 in response to this FOA.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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:

Brenda Lange-Gustafson, PhD
Telephone: 240-669-5047
Fax: 301-480-2408
Email: bgustafson@niaid.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Administrative Core)	12
Core (Use for Scientific or Resources Cores)	12
Project (Use for Research Projects)	12

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: Required
• Administrative Core: Required; maximum of 1
• Scientific or Resources Cores: Optional, but each Core should support research projects.
• Research Projects: Required, Minimum of 2

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. The PD(s)/PI(s), or the Contact PD/PI for Multi-PD/PI applications, will oversee, manage and coordinate the research of the Center; ensure that the individual Cores and research projects are synergized to advance the goals of the Center; oversee any Pilot Developmental Research Projects; and serve as the principal point(s) of contact for the Center. The biosketch should reflect the experience and expertise that demonstrate the ability of this individual to manage all aspects of the Center successfully.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Center. Concisely describe the hypothesis or hypotheses to be tested

Research Strategy: Summarize the overarching theme of the proposed Center program. The multi-component, multi-disciplinary application should be viewed as a confederation of interrelated Cores and research projects, each capable of standing on its own merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the entire program and then lays out a broad strategy for accomplishing the stated goals. When developing the CRC’s design, each Core and research project should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique. A visual representation of the interactions amongst the components and complementary scientific endeavors can assist reviewers in evaluating the collaborative and synergistic potential of the proposed CRC.

Note: Collaborative efforts between the Tissue Engineering and Infectious Diseases investigators represent a new frontier for these scientific communities; thus, substantial preliminary data shall not be required. However, sufficient information should be supplied to establish feasibility. Moreover, in depth communication and collaboration between the infectious diseases and tissue engineering/tissue biology experts are critical for success; thus, applicants must define how these experts will work together.

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

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

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

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

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

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• For institutions/organizations proposing a single PD/PI, the PD/PI will serve as the Administrative Core Director. For institutions/organizations proposing multiple PD(s)/PI(s), the Contact PD/PI must serve as the Administrative Core Director. Through the required Administrative Core functions indicated below, the Administrative Core Director provides leadership and guidance in fulfilling the stated objectives of his or her Center, and is responsible for generating, within the Administrative Core, an infrastructure that promotes cross-discipline interactions among all of the Cores and Research Projects, and provides oversight and governance over fiscal and resource management.

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

Pilot Developmental Research Projects (DRP): Request funds for DRPs in the Administrative Core budget. Individual DRP awards may not exceed $75,000 direct costs per year and are limited to no more than two years duration, without prior input from the EC. Centers are limited to no more than two new DRPs per year and the total number of DRPs to be supported during the duration of the award is at the discretion of each Center site. Centers should initiate DRPs within the second year of the award.

Meetings: Request funds to attend the Kick-Off Meeting and Annual Programmatic Meeting. Annual Programmatic Meeting of all Centers funded under this FOA are to start during the second year of award. Each Center should fund travel and attendance at yearly meetings by the PD(s)/PI(s), the Project Leads and Core Leads, and other Key Personnel who are expected to attend. These individuals should also budget and plan to attend the Kick-Off Meeting to be held within six months of award. These meetings are anticipated to be held at a location at/near Bethesda, Maryland or at another agreed-upon site following consultation with NIAID staff. Travel and per diem costs to attend the Annual Programmatic Meeting must be included in the budget; costs associated with organizing the Annual Programmatic Meeting are not allowable expenses.

External Scientific Consultants: Request funds for the optional ESC panel. For example, consider costs associated with site visits by the ESCs.

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

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Administrative Core.

Research Strategy: Describe plans and procedures for establishing and managing an Administrative Core that provides the organizational capacity to ensure the following:

• Coordinating, supervising and managing all Center activities, which includes sponsoring activities to advance the Center’s integration.
• Providing a supportive structure sufficient to ensure the accomplishment of all CRC goals.
• Assisting Core and Research Project Leaders with administrative aspects of their projects, such as gathering of annual progress reports and facilitating other communications with awardees and their mentors.
• Promoting collaboration and coordination among Core and Research Project Leaders.
• Communicating with other Centers regarding collaboration and coordination of activities and projects.
• Fostering outreach activities to promote collaborations with the pertinent scientific communities.
• Communicating and interacting with the NIAID Project Scientist, Program Officer, or other staff.

Management Plan-Required: Include a Management Plan that describes the organization of the proposed program and its management structure. The Management Plan must include:

• A description of how the organization of the Center and its management structure will form a cohesive, integrated and efficient Center that provides scientific and administrative oversight of all CRC Cores and Research Projects.
• An overview of how the multiple Research Projects will be coordinated, integrated, and scientifically and technically managed to answer the scientific questions and hypotheses proposed within the application and within the scope of the FOA.

The Management Plan must also include a Staffing Plan that describes:

• The structure and roles of administrative and scientific staff; and
• How the collective training and experience of proposed staff contributes to the functions to be performed.

Pilot Developmental Research Project Plan-Required: Include a DRP Plan that describes procedures for requesting pilot DRPs; selecting the most promising projects; and monitoring success/productivity of the pilot DRPs. However, do not include descriptions of projects that would be supported by DRP funds; these will be proposed, selected and approved after award.

Include the internal institutional plans and procedures to ensure that all DRPs supported from this award will comply fully with all applicable Federal regulations, policies, and Guidelines for research involving vertebrate animals and human subjects, which includes the evaluation of risks and protections for human subjects in the proposed projects as well as the appropriate ethical oversight of funded projects.

Human Subject approval dates for pilot DRPs (if applicable) should NOT be submitted with the application, but should be provided to the NIAID for approval prior to the start of the pilot DRP, and with annual progress reports.

External Scientific Consultant (ESC) Optional: The formation of an ESC group is encouraged, but optional. If under consideration, please describe how the ESC will function, but do not name any of the prospective members.

Note: The Management Plan and Developmental Research Project Plan sections should be clearly indicated in the application.

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

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

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

PHS Inclusion Enrollment Report (Administrative Core)

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

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

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

SF424 (R&R) Cover (Scientific/Resources Cores)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific/Resources Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific/Resources Cores)

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

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

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

Project /Performance Site Location(s) (Scientific/Resources Cores)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Scientific/Resources Cores)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component and describe the expertise each contributes to the Core. Likewise, list any other significant contributors and expertise that is relevant to the success of the Core.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Core should be headed by a Core Leader whose expertise is appropriate to manage all aspects of that particular Core successfully.

Budget (Scientific/Resources Cores)

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

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

PHS 398 Research Plan (Scientific/Resources Cores)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Core.

Research Strategy: Describe how the proposed Core activities will contribute to meeting the Center's goals and objectives and explain the rationale for selecting the general methods and approaches to accomplish the Core activities. Indicate the relevance of the Core to the primary theme of the application, and provide justification for the Core to support at least one of the proposed two or more Research Projects. Applications that propose Shared Cores must give a clear description of the facilities, techniques, and skills that the Core will provide to the Research Projects. Core(s) should not be duplicative of other services or facilities available to the CRC investigators. Examples of services that might be provided by a shared Core include tissue construct resources and fabrication, microbiota resources, clinical specimen acquisition, or statistical support.

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.

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

PHS Inclusion Enrollment Report (Scientific/Resources Cores)

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

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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

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

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

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Research Project should be headed by a Project Leader whose expertise is appropriate to manage all aspects of the project successfully. In particular, the scientific expertise of the Project Leader should be reflected in the goals and objectives of the proposed Research Project.

Budget (Research Project)

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

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

PHS 398 Research Plan (Research Project)

Specific Aims: List, in priority order, the broad long-term goals and specific objectives of the proposed Research Project. Concisely describe the hypothesis or hypotheses to be tested. In addition, state the Research Project’s relationship to the Center s goals and how they relate to other Cores or Research Projects in the application.

Research Strategy: Describe how the proposed project will contribute to meeting the Center’s overall goals, and explain the rationale for selecting the methods to accomplish the Specific Aims. State the biological significance of the research, and indicate the project's relevance to the primary theme of the application.

Given the overall focus of developing novel in vitro tissue models, the potential of these constructs to model the human disease is a critical component. Iterative microbial pathogenesis studies may be used to refine model systems; these experiments may reflect or confirm established knowledge. As the model begins to replicate in vivo pathogenesis, more advanced infectious diseases/microbiology studies should be initiated. Ultimately, the experimental designs and approaches for both microbiology/infectious diseases and bioengineering studies should be commensurately advanced, with pathogenesis studies focused on addressing critical gaps or obstacles in infectious diseases.

Describe the research design, conceptual procedures, and analyses to be used to accomplish the Specific Aims of the project. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss associations with Core(s) or other Research Projects. Discuss the potential difficulties and limitations of the proposed procedures and provide alternative approaches to achieve the aims.

Milestones and Timelines: - Required. A milestones and timelines section must be provided for each Research Project that addresses all research activities.

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

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

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

PHS Inclusion Enrollment Report (Research Project)

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

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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. 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.

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. 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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

Applicants may provide late-breaking results from preliminary studies prior to review, but no later than 30 days before the date of the scientific review meeting. Applicants are encouraged to contact the Scientific Review Officer for any clarification.

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.

For this particular announcement, note the following:

The following statement should be used as the conceptual basis for the use of the term, tissue engineering: Tissue engineering brings together the knowledge of cells, cellular environment and materials, and this can be coupled with biochemical cues to replicate tissues and their functions (paraphrased from the Journal of Tissue Engineering.) Collaborative efforts between the Tissue Engineering and Infectious Diseases Community represent a new frontier for these scientific communities; thus, substantial preliminary data are not required. High risk, high reward approaches with documented expertise and feasible methodologies are welcome. Given the overall focus of developing novel in vitro tissue models, the potential of these constructs to model the human disease is a critical aspect. Iterative microbial pathogenesis studies may be used to refine model systems; these experiments may be incremental and reflect or confirm established knowledge. As the model begins to replicate in vivo pathogenesis, more advanced infectious diseases and microbiology studies should be initiated.

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

Reviewers will consider each of the review criteria below in the determination of scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

• Are the overall goals of the Center conducive to generating significant multidisciplinary investigations that respond to the overall objectives of the FOA, i.e., generating novel models for studies of infectious diseases that will advance basic science and/or product development?
• Does the Center focus on critical gaps to address important questions or obstacles in infectious disease studies?
• Does the Center provide a feasible strategy for collaboration among the scientific fields relevant to this FOA, i.e., infectious diseases, tissue engineering, and, optional, the microbiota/microbiome?
• Do all of the individual projects relate to the overall goals of the Center and provide a cohesive and synergistic whole?
• Will successful completion of the Center goals impact the understanding of microbial pathogenesis and, in the long-term, advance the capacity to develop interventions more effectively?
• Does the Center PD(s)/PI(s) have the leadership and scientific ability, scientific and technical skills, and managerial competence to develop, manage, and direct an integrated and focused research Center, including the time commitment and demonstrated ability to establish and manage collaborations?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research 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. A project does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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

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

Does the Project Lead have documented training, leadership skills, scientific and technical skills, and managerial competence to successfully plan, manage, conduct and direct a Research Project? Does he/she have demonstrated ability to manage this project and establish collaborations? Does the Project Lead have a successful record of collaborations within his/her scientific community and appropriate track record for collaborative activities? Are the proposed Key Personnel /research staff for the project appropriate and do they have the expertise to carry out the work?

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?

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

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

Are the experimental designs and approaches for both microbiology/infectious diseases and bioengineering studies commensurately advanced? Do the microbiological studies address critical gaps or obstacles in infectious diseases? Are the cell sources, reagents, and other bioengineering tools sufficiently advanced to accomplish the work proposed?

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?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core activities to meet the needs of individual Research Projects or other Cores, and to contribute to the Center s goals and objectives, in consideration of the following points (as applicable for the Core proposed). A Core does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Core that, by its nature, is not innovative may be essential to advance a field.

Reviewers will consider each of the points below, as appropriate for Admin Core, in the determination of scientific merit and provide an overall impact score, but will not give separate scores for these items.

• Are the Management and Staffing Plans appropriate to facilitate attainment of the objectives of the proposed Center?
• Are the experience, level of commitment, and availability of the Admin Core Director adequate to manage the overall Center?
• Is the plan to establish and manage the pilot Developmental Research Program adequate and appropriate?
• Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate?
• Are the proposed timelines and performance objectives for the overall Center adequate?
• Is the management plan for fiscal accountability and communication within the Center appropriate?
• For Pilot Developmental Research Projects: are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Reviewers will consider each of the points below, as appropriate for the individual Core, in the determination of scientific merit and provide an overall impact score for each Core, but will not give separate scores for these items.

• Are the proposed Cores justified and relevant to the theme of the overall Center?
• Is adequate justification provided for how each Core will support one or more Research Project(s)?
• Are the facilities or services provided by the Core (including procedures, techniques, and quality control) high quality?
• Will the services be used effectively?
• Are the Core Leader and Key Personnel well qualified and is there an adequate commitment of time?

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

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

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

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

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

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 .

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.

Awardee-selected projects that involve studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other 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, managing, and coordinating the Research Projects and Cores within the overall Center;
• Ensuring that the individual projects and Cores are synergized to advance the goals of the Center;
• Retaining primary responsibility for the planning, directing, and executing the proposed scientific activities;
• Overseeing the Pilot Developmental Research Projects;
• Ensuring that all Pilot Developmental Research Projects (DRPs) involving human or animal subjects have the appropriate clearances (e.g., IRB, FWA, IACUC, human subject’s research training, and other required documentation) prior to implementation;
• Submitting yearly progress reports for the Center as a whole and for each individual Research Project;
• Participating in Executive Committee (EC) meetings, teleconferences, and other activities to be defined over the course of the award period;
• Keeping the NIAID Program Official apprised of any potential impediments to execution of the goals of any one Research Project or Core;
• Establishing an Annual Programmatic Meeting agenda; and
• Extending invitations to the NIAID Project Scientist and Program Official for specific Center meetings, including the Annual Programmatic Meetings. This provides an opportunity for better communication and guidance among the specific researchers and the NIAID.
• Coordinating the management of all funds to Pilot Developmental Research Projects and interface with NIH Grants Management offices and sponsored projects (grants) offices at awardees' institutions.

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.

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

The role of the NIAID Project Scientist (PS) in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s).

• The PS will work closely with the PD(s)/PI(s) and other Center member scientists to facilitate collaborations and to leverage the resources available to the Center;
• The PS will monitor the progress of the Center, help coordinate research approaches, and contribute to the shaping of research projects or approaches as warranted. The PS will support and facilitate this process but will not direct it;
• The PS will keep the Center informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research. The PS will coordinate access for the Center to other NIAID resources, as well as assist the research efforts of the Center by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate;
• The PS will serve as a non-voting member of the Center s Executive Committee (EC) and will assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action;
• The PS will retain the option to recommend, within the NIH grants policy, the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award;
• The PS will assist in the determination of the site for the Annual Programmatic Meeting; and
• The PS will coordinate the monthly conference calls with PD/PI as needed.

Additionally, an NIAID Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The NIAID Project Scientist (PS) and the PD(s)/PI(s) will coordinate to facilitate the achievement of program goals.
• Center Executive Committee (EC). A Center Executive Committee (EC) will be established to participate in the review and recommendation of the pilot Developmental Research Projects from each Center. The PD(s)/PI(s) from each Center and the PS named in the award notice will form the EC. The EC will select one PD/PI from among the awardees to serve as Chair of the Committee. The EC must meet face-to-face within six months of award at a location to be determined by the PS. This will be in conjunction with the Kick-Off Meeting. The EC will meet annually in conjunction with the Annual Programmatic Meetings, and additionally as needed via conference calls with the PS to facilitate interactions and collaborations across the Centers. Meetings may also be used to address common training needs, develop cross-Center initiatives, or host invited speakers.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Melody Mills, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3318
Email: millsm@niaid.nih.gov

Brenda Lange-Gustafson, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5047
Email: bgustafson@niaid.nih.gov

Jordan A. Kindbom
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2983
Email: jordan.kindbom@nih.gov

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.