It is critical that applicants follow the Multi-Project (M) 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 the Funding Opportunity Announcement (FOA) is to solicit applications for a Coccidioidomycosis Collaborative Research Centers (CCRC) program. This new initiative will establish highly collaborative, multi-disciplinary research teams to conduct translational and clinical research for the improved diagnosis, treatment and prevention of coccidioidomycosis (Valley fever).

Coccidioidomycosis (Valley Fever) is a systemic infection caused by Coccidioides immitis and C. posadasii. These soil-dwelling, dimorphic fungi are found in arid, desert-like conditions throughout the southwestern United States (primarily Arizona, California, Nevada, New Mexico, Texas and Utah), as well as in parts of Mexico, Central America and South America. The incidence of Valley fever is increasing, as is the geographic area of endemicity for Coccidioides spp. In 2018, more than 15,000 cases were reported to the Centers for Disease Control and Prevention (CDC). Arizona and California have the highest number of cases in the United States and each reported more than 7,000 in 2018. However, the CDC estimates the disease to be underreported, and that tens of thousands more cases likely occur annually. Lack of awareness and absence of rapid testing may contribute to underreporting and delays in diagnosis. The cost of Valley fever is substantial, and California estimated the total lifetime cost burden for cases reported in 2017 at just under $700 million.

Valley fever is usually self-limiting. However, 40 percent of people infected experience significant flu-like symptoms that can last weeks to months and require antifungal therapy to clear the infection. Severe disseminated disease occurs in one percent of infected individuals and these individuals may require life-long antifungal therapy. While dissemination is rare, it is more common among Filipinos, African Americans, and Native Americans; in people with a weakened immune system; and in women during the third trimester of pregnancy. Approximately 200 people die each year in the United States from Valley fever.

Although progress has been made in understanding Coccidioides biology and the host response to infection, significant scientific knowledge gaps and obstacles for this field remain. For example, more research is needed to define the host factors that contribute to the broad spectrum of disease severity, to determine the association between pathogen diversity and disease outcomes, and to identify natural reservoirs of the pathogen. In addition, additional efforts are needed to coordinate access to clinical samples and patient populations in order to improve outcomes for individuals impacted by this emerging pathogen.

Historically, the number of researchers and collaborative efforts in this field have remained small, perhaps due in part to the required BSL3 laboratory conditions or the endemic nature of this pathogen. The CCRC program is designed to foster partnerships and attract infectious disease physician-scientists and researchers with expertise in immunology, epidemiology, fungal genomics and mycobiology. Together, these teams can fill knowledge gaps by integrating basic, translational and clinical research on Valley fever, with the long-term objective to advance our understanding of the disease and improve approaches to prevention, diagnosis and treatment.

This initiative will establish collaborative research centers to conduct multi-disciplinary research focused on a unifying theme to improve understanding and treatment of coccidioidomycosis (Valley fever). It is expected that the multi-disciplinary centers will leverage unique research resources and patient populations from endemic regions to advance the field.

NIAID anticipates considerable variety among the proposed program themes and objectives. It is envisioned that overarching themes could include, but are not limited to:

• Discovery and validation of novel therapeutic, diagnostic or vaccine targets/pathways.
• Elucidating mechanisms of disease severity and dissemination.
• Understanding treatment failure in certain individuals.
• Understanding why people of color are at increased risk of disease.

CCRC multidisciplinary research projects contributing to a unifying theme could include, but are not limited to:

• Discovery and functional characterization of fungal and host factors that contribute to disease.
• Identification of genotypic and phenotypic fungal and host markers associated with disseminated disease.
• Studies to improve understanding of the host response to infection including identification of correlates of immune protection to inform vaccine, immunotherapeutic, and immunomodulatory research.
• Discovery research to enable development of rapid, sensitive, and accurate diagnostics.
• Discovery research to enable development of new therapeutics and vaccines.
• Identification of natural reservoirs that contribute to disease burden.
• Observational/clinical studies to understand spectrum of disease, inform future clinical trials, and provide biospecimens for translational research.
• Systems-level approaches to identify host and fungal molecular interactions important for infection and immunity.
• Computational approaches to integrate data derived from multiple sources (e.g., transcriptomics, proteomics, metabolomics, electronic health records) to identify molecular (biomarker) signatures associated with protection against, and resolution of, Valley fever.

Applications including the following types of studies will be considered non-responsive and will not be reviewed:

• Applications that focus on HIV/SIV/AIDS
• Applications that do not include at least one project that includes clinical research
• Clinical trials: Clinical research may be supported but not clinical trials See NOT-OD-15-015 for the NIH Definition of a Clinical Trial.

Collaborative Interdisciplinary Teams

The scope of this work requires that multidisciplinary teams be formed that can pursue coordinated activities that can bridge both basic/translational and clinical research. Each CCRC is expected to include researchers with unique and diverse expertise that will enhance the overall quality of the Center. This expertise may be in any discipline that will contribute to the success of the Center. However, one Research Project at each center must include clinical research. Since collaborative efforts between multi-disciplinary teams focused on coccidioidomycosis may represent a recent alliance, substantial preliminary data shall not be required.

Examples of CCRCs:

The following are examples and do not reflect the full range of potential programs:

As an example, a CCRC focused on elucidating mechanism of disease severity and dissemination could bring together investigators and clinicians with expertise in fungal biology, genetics, computational genomics, immunology and access to patient specimens and or cohorts.

As a second example, a CCRC focused on identifying and validating new strategies for vaccine development could bring together investigators and clinicians with expertise in fungal biology, genomics, immunology, vaccinology, animal models, and access to patient specimens and or cohorts.

As a third example, a CCRC focused on understanding treatment failure in certain individuals could bring together investigators and clinicians with expertise in fungal biology, immunology, genetics, computational biology, pharmacology, and access to patient specimens and or cohorts.

CCRC Program Components

This research program shall consist of an Administrative Core, at least two Research Projects organized around a common theme and may include up to two Scientific or Resource Core(s). Component projects and cores within a single application should not only relate to a central theme relevant to Valley fever, but also relate to the other components within the same application. The components of an application include:

Administrative Core: Each CCRC must include an Administrative core that will be responsible for managing, coordinating, and monitoring overall progress, and supervising the entire range of the center's activities, including the Developmental Research Program (DRP) and ensuring compliance with the Center s data sharing plan.

Scientific/Resource Core(s): Each CCRC may include a maximum of two Scientific/Resource Core(s) to provide shared support services to the Research Projects. Cores must be well justified, provide support for at least two Research Projects, and be clearly non-duplicative of other services or facilities available to CCRC investigators. Examples of services provided by a shared Scientific/Resource Core are monoclonal antibody production, peptide syntheses, microbiology laboratory services, statistical support, animal core, or a clinical core that will provide clinical samples to other cores and projects.

Research Projects: Each CCRC must propose a minimum of two Research Projects organized around a common theme. At least one research project must include clinical research. Together, the collaborative projects should advance the understanding and/or treatment of Coccidioidomycosis (Valley fever).

Development and Research Program (DRP) Awards: A DRP must be implemented by each CCRC to provide an opportunity to test novel ideas, develop new technologies, or provide further training in certain areas under investigation by the Center. Each CCRC is limited to supporting no more than two DRP awards per year, although the total number of DRP awards that a Center can support during the entire award project period is left to the discretion of the Center. DRP awards are intended for early-stage investigators (e.g., Ph.D., M.D. fellows and Assistant Professors) or researchers new to the field of Coccidioidomycosis research.

Annual Programmatic Meetings: Annual Programmatic Meetings must be held to facilitate communication and collaboration among funded CCRCs.

CCRC Executive Committee (EC): A CCRC Executive Committee (CCRC-EC) will be established by the NIAID Project Scientist to facilitate interaction, collaboration, and communication among the CCRCs and NIAID staff. The CCRC-EC will include the PD/PI of each CCRC. The CCRC-EC will be selected by NIAID after award and members should not be proposed or contacted by applicants. The CCRC-EC must meet within three months of award in conjunction with the first Annual Programmatic Kick-Off Meeting. Thereafter, the CCRC-EC will meet annually in conjunction with the Annual Programmatic Meetings, and quarterly, or as needed, via conference calls. The CCRC-EC will meet to determine the DRP awards.

Data Sharing: It is critical to enhance data-sharing and access to ensure that NIAID-funded data be Findable, Accessible, Interoperable, and Reusable (FAIR). All NIAID-funded researchers are expected to share research data to enhance the rigor and reproducibility of research results and secondary use per the NIAID Data Sharing Guideline at:

https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines, as appropriate and consistent with achieving the goals of the program.

NIH and NIAID support several open domain-specific repositories and knowledgebases for broad sharing of data with the larger research community. However, we recognize that not all data have domain-specific repositories or allow self-publishing. There are several generalist repositories that can fill this gap. Researchers are encouraged to use one of their choice and/or work with their institutional library-supported repository to rapidly self-publish all useful and usable data rapidly.

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) 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.
• o 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
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).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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, Ph.D.
Telephone: 240-627-3390
Fax: 301-480-2408
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core (use for Administrative Core)	6 pages
Core (use for Scientific/Resource Cores)	6 pages each
Project (use for Research Projects)	12 pages each

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/Resource Cores: Optional, maximum of 2
• Research Projects: Required, minimum of 2, no maximum

When preparing your application, 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.

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 program. Concisely and realistically describe the hypothesis or hypotheses to be tested.

Research Strategy: This section summarizes the overall research strategy for the multi-project application. The multi-component, multi-disciplinary application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific 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 overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.

• Summarize the overarching theme of the proposed CCRC program, and explain how, in the long-term, the work proposed can address critical gaps, longstanding obstacles, or key biomedical questions in infectious diseases research.
• Describe how the proposed studies will promote a multidisciplinary, diverse set of research activities to promote understanding and treatment of coccidioidomycosis (Valley fever).
• Describe how the individual projects and cores relate to the overall goals of the Center and provide a cohesive and synergistic whole that is more beneficial than pursuing each project independently.
• Discuss how the multi-disciplinary centers will leverage unique research resources and patient populations from endemic regions to advance the field.
• 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 CCRC.
• Note: Collaborative efforts between multi-disciplinary teams focused on coccidioidomycosis may represent a recent alliance; thus, substantial preliminary data shall not be required. However, without duplicating information in the biosketches, sufficient information about the scientific expertise and technical capabilities of the investigative team members should be supplied to establish feasibility, i.e., the potential to accomplish the work proposed. Moreover, in depth communication and collaboration between the multi-disciplinary teams 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 modifications:

• It is expected that awardees will rapidly disseminate data, results, and analyses to the broader scientific community, using existing public repositories whenever possible, as a foundation for further study.
• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
• The Data Sharing Plan must ensure that the data are Findable, Accessible, Interoperable, and Reusable (FAIR) per the NIAID Data Sharing Guideline at https://www.niaid.nih.gov/research/data-sharing-and-release-guidelines, as appropriate and consistent with achieving the goals of the program.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, 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 CCRC, 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.

• Development and Research Program (DRP) awards: Include a maximum of $80,000 direct costs per year (beginning in Year 1), for a maximum of two DRP awards per year; with each award not to exceed two years.
• Include travel funds for the PD(s)/PI(s), Research Project Leaders and Core Leaders to attend the Kick-Off meeting, to be held within 3 months of award, in the Rockville, MD area (for a 1-day meeting).
• Include travel funds for the PD(s)/PI(s), Research Project Leaders, Core Leaders, presenters, and DRP award recipients to attend the Annual Programmatic meetings, to be held annually beginning in Year 2, in the Rockville, MD area or in the location of one of the CCRCs (1 day per annual meeting).
• Travel and per diem costs to attend the Annual Programmatic Meeting must be included in the budget.
• Costs associated with organizing an Annual Programmatic Meeting are not allowable expenses.

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 CCRC activities, which includes sponsoring activities to advance the CCRC’s integration.
• Providing a supportive structure sufficient to ensure the accomplishment of all CCRC 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 CCRCs 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: Each CCRC must include a Management Plan that describes the organization of the proposed program and its management structure. The Management Plan sections should be clearly indicated in the application. The Management Plan must include:

• A description of how the organization of the CCRC and its management structure will form a cohesive, integrated and efficient CCRC that provides scientific, fiscal, and administrative oversight of all CCRC 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.

Development and Research Program (DRP) Plan: Include a DRP Plan that describes strategies to establish and manage the DRP, as well as mentor junior investigators. The plan should describe how pilot DRP awards will be integrated into an awardee's career development objectives. Include plans for the logistics for solicitation, receipt, and review of applications, as well as award. Describe the internal institutional plans and procedures to ensure that DRP award recipients will comply fully with all applicable Federal regulations, policies, and guidelines for research involving vertebrate animals and human subjects, including, for human subjects, the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects. Note: This section should only include information about the establishment and management of the DRP and should not include any DRP proposed research projects.

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:

Not Applicable for each component. A Resource and Data Sharing Plan should be submitted only in the Overall section. See instructions in Overall section.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type 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.

Facilities & Other Resources: Include an attachment entitled "Facilities & Other Resources" to provide information on resources available for the Scientific/Resource Core. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities available to be used for working with Coccidioides spp.

Equipment: Include an attachment entitled "Equipment" to provide information on equipment available for the Scientific/Resource Core. If there are multiple performance sites, describe the equipment available at each site. Describe any special equipment available to be used for working with biohazards or other potentially dangerous substances, as well with Coccidioides spp.

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.

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• 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.
• The Core should be headed by a Core Leader whose expertise is appropriate to manage all aspects of that particular Core successfully.

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

For Cores (Clinical or otherwise) obtaining samples from independently-funded clinical trials, include the following costs, when such costs are not included in the Research Projects: additional clinical trial-related activities such as the costs of re-consenting study participants; preparation of protocol or IND amendments; and additional sample collection, preparation, and shipping.

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 Core.

Research Strategy: Describe how the proposed Core activities will contribute to meeting the CCRC'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 two of the Research Projects. Explain how requests will be prioritized and coordinated. In a clearly labeled section provide annual timelines and milestones for the proposed core services. Note: timelines for clinical research study records are requested as part of the PHS Human Subjects and Clinical Trials information and should not be repeated in this section.

Letters of Support: Provide letters of support from collaborators that are applicable to the Scientific/Resource Core. For example, for a Clinical Core that will be collecting and dispersing human tissue samples, include a Memorandum of Understanding (MOU) or Materials Transfer Agreement (MTA) that documents availability and/or access to human materials for each source (i.e., sample availability corresponding to the outlined timelines).

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:

• Not Applicable for each component. A Resource and Data Sharing Plan should be submitted only in the Overall section. See instructions in Overall section.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Project.

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.

Facilities & Other Resources: Include an attachment entitled "Facilities & Other Resources" to provide information on resources available for that project. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities available to be used for working with Coccidioides spp.

Equipment: Include an attachment entitled "Equipment" to provide information on equipment available for that project. If there are multiple performance sites, describe the equipment available at each site. Describe any special equipment available to be used for working with biohazards or other potentially dangerous substances, as well with Coccidioides spp.

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

If samples for the proposed studies are to be collected from an independently-funded clinical trial include the following costs, when such costs have not been included under a Scientific/Resource Core: the costs of re-consenting study participants, preparation of protocol or IND amendments, and additional sample collection, preparation, and shipping.

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-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 CCRC 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 CCRC’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.

Describe the research design, conceptual procedures, and analyses to be used to accomplish the Specific Aims of the project, emphasizing how these will contribute to improved understanding and treatment of coccidioidomycosis (Valley fever). 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. The use of clinical samples is strongly encouraged where applicable and/or appropriate, but the use of clinical samples is not necessarily required for all projects.

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:

• Not Applicable for each component. A Resource and Data Sharing Plan should be submitted only in the Overall section. See instructions in Overall section.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

Important reminders:

All PD(s)/PI(s) 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 the policy. Any instructions provided here are in addition to the instructions in the policy.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the CCRC 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 program 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 program that by its nature is not innovative may be essential to advance a field.

Does the program 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 program 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?

Specific to this FOA:

• Is the CCRC as a whole scientifically compelling?
• Does the CCRC focus on critical gaps to improve understanding and/or treatment of coccidioidomycosis (Valley fever)?

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

Specific to this FOA:

• Do the PD/PIs have the leadership, scientific, and managerial experience required to develop, manage, and direct an integrated and focused program?
• Since collaborative efforts between multi-disciplinary teams focused on coccidioidomycosis may represent a recent alliance, substantial preliminary data shall not be required. However, will the expertise of the collaborative team provide a complementary base to achieve the overarching goals of the center?

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

If the program involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

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

Specific to this FOA:

• Do all of the individual projects relate to the overall goals of the CCRC and provide a cohesive and synergistic whole?

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

Specific to this FOA:

• Do the multi-disciplinary centers leverage unique research resources and patient populations from endemic regions to advance understanding of coccidioidomycosis?

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. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

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

Environment

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

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 CCRC’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 the Cores, in the determination of scientific merit and provide an overall impact score but will not give separate scores for these items.

Administrative Core

• Is the administrative and organizational structure appropriate and adequate to achieve the goals of the proposed program?
• Is the Management Plan appropriate to facilitate achievement of the objectives of the proposed program?
• Is the Management Plan for fiscal accountability and communication within the program appropriate?
• Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate?
• Are plans for facilitating communication between the projects (and Core(s) if applicable) appropriate?
• Is the plan to establish and manage the Developmental Research Program Plan adequate and appropriate?
• Are the experience and level of commitment of the Administrative Core Director adequate to manage the overall program?

Scientific/Resource Core(s) if applicable

• Are the proposed Scientific/Resource Cores sufficiently justified and relevant to the theme of the overall program?
• Is adequate justification provided that each Scientific/Resource Core will support at least two Research Projects and that services will be used effectively?
• Are the facilities or services provided by the Scientific/Resource Core(s) of high quality?
• Are the Scientific/Resource Core(s) Leader(s) and other key personnel well qualified with an adequate commitment of time?

As applicable for the program/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.

Data Sharing Plan:

Is the Data sharing plan for each CCRC appropriate and adequate to ensure that NIAID-funded data will be Findable, Accessible, Interoperable, and Reusable (FAIR)?

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 program/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) Sharing Model Organisms; and 2) 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.

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

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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 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, managing, and coordinating the Research Projects and Cores within the overall CCRC;
• Ensuring that the individual projects and Cores are synergized to advance the goals of the CCRC;
• Retaining primary responsibility for the planning, directing, and executing the proposed scientific activities;
• Report on yearly progress for the CCRC as a whole and for each individual Research Project according to proposed milestones;
• Participating in CCRC-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 when serving as the CCRC-EC Chair; and
• Extending invitations to the NIAID Project Scientist and Program Official(s) for specific CCRC-EC meetings, including the Annual Programmatic Meetings.

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

• The NIH Project Scientist will periodically review data and monitor progress of the program and help coordinate research approaches among all programs funded through the FOA.
• Keep the program informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing and collaborations.
• Facilitate collaborations with and access to other NIAID-supported research resources and services.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The NIAID Project Scientist and the PD/PI will hold regular discussions to facilitate achievement of the program’s goals.
• In the event that areas of common research interests develop across funded programs from the FOA, the NIAID Project Scientist will coordinate with the PD/PI(s) to facilitate collaborative activities.

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.

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Dona Love, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-695-7097
Email: [email protected]

Annie Walker-Abbey, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240- 627-3390
Email: [email protected]

Shan Liang
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7415
Email: [email protected]

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.