RFA-AI-27-012-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Coccidioidomycosis Collaborative Research Centers (P01 Clinical Trial Not Allowed)

Activity Code

P01 Research Program Projects

Announcement Type

New

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-AI-27-012

Companion Notice of Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.855

Notice of Funding Opportunity Purpose

The purpose of the notice of funding opportunity (NOFO) 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 to support the development of a Valley fever vaccine as outlined in NIAID’s Strategic Plan for Research to Develop a Valley fever Vaccine.

Funding Opportunity Goal(s)

To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials. To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.

Key Dates

Posted Date

May 04, 2026

Open Date (Earliest Submission Date)

June 09, 2026

July 09, 2026

Not Applicable

Not Applicable

March 2027

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

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

Expiration Date

July 10, 2026

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of 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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background Coccidioidomycosis (Valley fever) is a systemic infection caused by Coccidioides spp. fungi. These soil-dwelling, dimorphic fungi are found in arid, desert-like conditions throughout the southwestern United States, as well as in parts of Mexico, Central America and South America. Improved medical countermeasures to treat coccidioidomycosis are urgently needed as the incidence of Valley fever continues to rise. Valley fever is usually self-limiting. However, 40% 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 1% of infected individuals and these individuals may require life-long antifungal therapy. While progress has been made in foundational understanding of pathogen biology and host response, development of genetic tools, and identification of potential immunogens for novel vaccine platforms, continued support is necessary to realize the promise of these emerging scientific advances to support a Valley fever vaccine.

Research Objectives and Scope This initiative will establish Coccidioidomycosis Collaborative Research Centers (CCRCs) to conduct multi-disciplinary research aligned with the priorities outlined in NIAID’s Strategic Plan for Research to Develop a Valley fever Vaccine. It is expected that the CCRCs will leverage unique research resources and patient populations from endemic regions to advance the field.

It is envisioned that overarching themes could include, but are not limited to:

Collaborative Interdisciplinary Teams The scope of this work necessitates that multidisciplinary teams be formed that can pursue coordinated activities that can bridge translational and clinical research. To enhance the overall quality and success of the Center, each CCRC should include distinct expertise. As an example, a CCRC focused on elucidating mechanism of disease severity, dissemination and correlates of protection 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 and access to patient specimens and or cohorts.

CCRC Program Structure This research program must consist of an Administrative Core, at least two Research Projects organized around a common theme, and up to two optional Core(s). Individual Research Projects and Cores, if proposed, within a single application should relate to the overall goals of the CCRC and provide an integrated and synergistic whole that is more beneficial than pursuing each project independently.

The components of an application include:

Administrative Core (required): 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 CCRC's activities, including the Development and Research Program (DRP). The Administrative Core Lead provides leadership and guidance in fulfilling the stated objectives of the CCRC, and is responsible for generating, within the Administrative Core, an infrastructure that promotes cross-discipline interactions among all the Cores and Research Projects and provides oversight and governance over fiscal and resource management.

Development and Research Program (DRP) Awards (required): A DRP must be implemented by each CCRC to provide an opportunity to test novel ideas and develop new technologies in certain areas under investigation by the CCRC. Each CCRC is limited to supporting no more than two DRP awards per year. 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.

Scientific Advisory Committee (optional): Each CCRC may establish a Scientific Advisory Committee (SAC), though this is not a requirement. An example of SAC duties could include making recommendations for the continuation or re-direction of the funded Research Projects and Cores to the PD(s)/PI(s). Do not name or contact potential external SAC members in the application prior to award.

Core(s) (optional): Each CCRC may include a maximum of two Cores to provide shared support services to the Research Projects. Each proposed Core 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 Core are a Fungal Genetic Knockout Core, Statistical Support Core or a Clinical Core.

Research Projects (required): Each CCRC must propose a minimum of two and a maximum of four Research Projects organized around a common theme. At least one Research Project must include clinical research utilizing Valley fever patient samples from the endemic areas. Together, the collaborative Research Projects should advance the understanding and/or treatment of coccidioidomycosis (Valley fever).

Annual Programmatic Meetings (required): Annual Programmatic Meetings and a kick-off meeting must be held to facilitate communication and collaboration among funded CCRCs. The PD(s)/PI(s) will organize annual meetings and will extend an invitation to NIAID Program staff and key personnel of all funded CCRCs.

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

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit $4.8M in FY 2027 to fund 3-4 awards.

Award Budget

Application budgets are not expected to exceed $1.2M direct costs per year, which includes up to $80,000 direct costs for up to two Development and Research Program (DRP) awards per year. Application budgets need to reflect the actual needs of the proposed project.

Award Project Period

The project period must be five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

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

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

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.

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 How to Apply - Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility Number of Applications

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package 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 NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Required

Required

Optional

Required

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) Complete entire form.

PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall) Follow standard instructions, with the following additional information:

Facilities & Other Resources: Describe how the multi-disciplinary CCRC will leverage unique research resources and patient populations from endemic regions to advance the understanding of coccidioidomycosis.

Project/Performance Site Locations (Overall) 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.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

Within the biosketches, highlight the Program Director(s)/Principal Investigator(s) leadership and scientific abilities to develop an integrated and focused research program.

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.

Budget (Overall) 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.

PHS 398 Research Plan (Overall)

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.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Administrative Core When preparing your application, use Component Type ‘Admin Core’.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core) 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) (Administrative Core) 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 (Administrative Core)

Budget (Administrative Core) 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 (Administrative Core) 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:

Management Plan: Provide a Management Plan that describes the organization of the proposed program and its management structure. The Management Plan section should be clearly indicated in the application. The Management Plan should include:

Development and Research Program (DRP) Plan: Include a DRP Plan that describes strategies to establish and manage the DRP, as well as to provide opportunities for the next generation of scientific leaders in Coccidioides research. The plan should describe how pilot DRP awards will be integrated into a DRP recipient's career objectives. Include plans for the logistics for solicitation, receipt, review and award of applications. Describe how the CCRC will monitor and ensure compliance of funded DRP projects involving human subjects or vertebrate animals (e.g., obtaining the appropriate approvals, evaluating risks and protections, and ensuring appropriate ethical oversight, etc.) at all participating institutions.

Note: This section should only include information about the establishment and management of the DRP and should not include any DRP proposed research projects.

Scientific Advisory Committee (SAC) (optional): If proposed, discuss the role of the SAC and how the SAC will be integrated into the operations of the CCRC, the procedures and approaches for obtaining a SAC input via teleconferences, ad hoc or annual meetings, review of written materials/data, etc. If the CCRC proposes a SAC, it must include the contact PD/PI. Do not name or contact potential external SAC members in the application prior to award.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core) 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Core(s) When preparing your application, use Component Type ‘Core’.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Core(s)) Complete only the following fields:

PHS 398 Cover Page Supplement (Core(s)) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core(s)) 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: Describe any special facilities available to be used for working with Coccidioides spp.

Equipment: Describe any special equipment available to be used for working with biohazards or other potentially dangerous substances, as well with Coccidioides spp.

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

Budget (Core(s)) 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 (Core(s)) 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 Research Projects. Explain how requests will be prioritized and coordinated.

Letters of Support: Provide letters of support only from collaborators that demonstrate the Core’s ability to perform its proposed tasks.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Core(s)) 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Research Projects When preparing your application, use Component Type ‘Project’.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Projects) Complete only the following fields:

PHS 398 Cover Page Supplement (Research Projects) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects) 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: Describe any special facilities available to be used specifically for working with Coccidioides spp.

Equipment: Describe any special equipment available to be used for working with biohazards or other potentially dangerous substances, as well with Coccidioides spp.

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

Budget (Research Projects) 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 Projects) 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 and Research Projects in the application.

Research Strategy: Describe how the proposed Research Project will contribute to meeting the CCRC’s overall goals. Indicate the project's relevance to the primary theme of the application.

Describe the conceptual procedures to be used to accomplish the Specific Aims of the Research Project, emphasizing how these will contribute to improved understanding and treatment of coccidioidomycosis (Valley fever). Discuss associations with Core(s), if proposed, and other Research Project(s). Describe plans for the use of clinical samples in at least one Research Project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Projects) 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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

4. Submission Dates and Times Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

6. Funding Restrictions 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - 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.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the…