RFA-AI-28-031-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)

Office of AIDS Research (OAR)

Funding Opportunity Title

Centers for Structural Biology of HIV and Other Infectious Diseases (U54 Clinical Trial Not Allowed)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

Funding Opportunity Number (FON)

RFA-AI-28-031

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.855, 93.310

Notice of Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to support multidisciplinary consortia of structural biologists, microbiologists, and associated experts to solve complex biological structures related to the prevention, treatment, and cure of HIV and other infectious diseases. Centers are expected to facilitate new collaborations, leverage shared resources, offer services and resources to the research community, and train the next generation of scientists engaged in structural biology of infectious diseases.

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

October 02, 2026

Open Date (Earliest Submission Date)

April 28, 2027

May 28, 2027

Not Applicable

Not Applicable

April 2028

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

May 29, 2027

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

Research Objectives The Centers for Structural Biology of HIV and Other Infectious Diseases aims to support innovative frontier science research that establishes new technologies and methodologies to provide insight into the mechanisms of host-pathogen interactions, as well as translational research to inform the development of novel and/or improved preventive interventions, therapeutics, diagnostics, and curative interventions across a broad spectrum of infectious diseases. These Centers focus on understanding the dynamics of molecular complexes, with the intention of informing mechanistically based discovery and/or design of interventions for the prevention, treatment, and cure of HIV and other infectious diseases. The goal is to facilitate the discovery of new therapeutic targets, new classes of interventions ranging from diagnostics, to small molecules and protein therapeutics, to neutralizing antibodies, and novel vaccine candidates, including nanoparticle vaccines, elucidate the mechanisms of action of interventions, and to determine the structural basis for interventional failures, but not support end-to-end preclinical development.

Of particular interest are the components of infectious agents and/or hosts for which sufficiently complete structures have yet to be determined, including macromolecular complexes of proteins, nucleic acids, carbohydrates, lipid membranes, and/or small molecules. The Centers will be responsible for the validation of structural data using biological, biochemical, and computational methods and artificial intelligence (AI) models to help understand the biological mechanisms and structure-function relationships of these complexes.

This program will establish up to:

Specific Areas of Research Interest include but are not limited to those listed below:

Center Organization The overall structure of the Center is designed to support multidisciplinary, multi-institutional consortia of infectious disease researchers in the conduct of their Research Projects, as well as to foster collaborations with the broader community of infectious disease researchers.

Administrative Core - Responsible for the overall organizational and administrative structure to manage, coordinate, and oversee all Center activities, including monitoring progress and timelines, information sharing, and shifting resources and priorities, as appropriate. The Core will aid in the coordination of consortium-wide working groups, engagement of new collaborators, adoption of new technologies, and guidelines for presentation and publication of the results of collaborative projects.

In case of a public health emergency or outbreak, in consultation with NIAID, the Administrative Core will shift the Center's priorities and reallocate Center resources to accommodate expanded collaborative work to solve critical structures and contribute to the discovery and development of interventions to support public health responses.

The Scientific Advisory Board (SAB) will serve as an independent, external advisory body that acts as a resource for the Principal Investigator(s) and Administrative Core, but it will not be involved in the day-to-day activities of the Center. The SAB will include at least 3 members not associated with the application.

Workforce Development Core - Provide educational and mentoring activities for students, postdoctoral fellows, and early career investigators either associated or not with the Center. Such activities may include workshops, or short courses open to the community at large, among others. Pilot awards may also be provided to early career investigators within the Center to promote their path to independence.

The Collaborative Development Award (CDA) program funds specific pilot research projects (1-3 awards per year) to support early career investigators and investigators new to a specific area of infectious disease research who are not associated with the Center.

Scientific Cores - Will support specific technologies or methodologies associated with the proposed Center to drive cutting-edge technology development and provide services, facilities, or resources vital to the Center. Scientific Cores will provide but are not limited to:

Service and Resource Core (only for Infectious Disease Centers) - Will solicit limited-scope, research concepts for structural biology collaborations from the research community to leverage the strengths, expertise, and resources of the Center to help solve challenging scientific questions beyond the scope of the Center's internal Research Projects. The Core will rapidly pivot in consultation with the Administrative Core and NIAID to address the scientific needs associated with emerging infectious disease outbreaks or public health emergencies.

Research Projects - Centers will be organized around Research Projects that will perform studies directed towards the overall Center goals. All HIV Center Research Projects will focus on HIV, with the option to include HIV-associated priority infections (tuberculosis and hepatitis B and C). Infectious Disease Centers will be dedicated to non-HIV NIAID infections, including viruses, bacteria and/or eukaryotic pathogens. Applications that include all three categories of pathogens are strongly encouraged. Research Projects will be aligned with NIAID priorities related to the prevention, treatment, or cure of infectious diseases.

Management, Operations and Collaboration - Each Center will actively seek collaborations with outside investigators to address gaps in infectious disease research and complement the Center's expertise. The set of possible targets for structure determination is very large. Thus, it is unreasonable to expect the Centers to possess the expertise to explore and develop all such targets. Therefore, it is essential that each Center has a mechanism and infrastructure for establishing and maintaining collaborations with outside researchers to pull together structural and functional studies across institutions.

The collaborative aspects of the overall program and coordination across the different Centers are essential for success. Regular communication and an annual joint meeting will ensure coordination and cooperation among the funded Centers and the other members of the scientific research community.

The following will be considered non-responsive and will not be reviewed:

Applicants are highly encouraged to contact the Scientific/Research Contacts to discuss their application and arrange a pre-application meeting prior to submission of their application.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

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 $33 million in FY 2028 to fund up to 6 HIV and up to 2 Infectious Diseases awards.

Award Budget

Application budgets are not expected to exceed $3.5 million in direct costs and need to reflect the actual needs of the proposed project.

Award Project Period

The total 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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST 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

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.

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.

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: Outline the scientific scope of the overall Center, the key questions to be addressed, and how the Center will help to inform and contribute to the discovery of innovative approaches to prevent, treat, or cure priority infectious diseases that impact human health.

Research Strategy: Discuss the rationale for the overall structure and staffing of the Center. Highlight the strengths of the team and unique resources that will be leveraged. Describe how the three Research Projects will address critical unsolved problems in our understanding of the structural biology of HIV and HIV associated priority infections or infectious diseases, according to the primary focus of the application. Explain how the topics to be studied involve structural complexes that cannot be readily solved using standard technologies funded by smaller individual research grants. Describe how multidisciplinary researchers will work together to solve these complex problems. Describe how the research plans will be flexible and adapt to accommodate the emergence of new data or technologies as the science evolves. Describe how the Scientific Cores will develop cutting-edge technologies to support two or more Research Projects. Highlight any institutional support and how it will be leveraged to advance the goals of the Center.

Outline the plan to mentor students, postdoctoral fellows and early career investigators and plans for outreach to solicit Collaborative Development Awards and (for Infectious Disease Centers only) to administer limited-scope projects through the Service and Resource Core. Detail other plans for educational outreach about structural biology to the broader research community.

Letters of Support: Provide letters of support providing evidence of institutional support and commitment, as well as access to critical facilities, equipment, resources, biospecimens, or collaborations.

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:

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) Follow standard instructions.

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.

Include funding for Center PD(s)/PI(s), Core, and Research Projects PD(s)/PI(s) to attend a Center kick-off meeting, an annual Scientific Advisory Board (SAB) meeting, and an annual joint meeting of all Centers in the Rockville, MD area. All meetings should be planned for one day and have options for both in-person and virtual attendance. Include funding for the establishment and activities of the Scientific Advisory Board (SAB).

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: Briefly outline the goals of the Administrative Core.

Research Strategy: Describe the overall management plan for the Center and the specific roles and responsibilities of each member of the Core. Describe how benchmarks and timelines will be tracked and policies and procedures for assessing progress, updating priorities, and adjusting resource allocations as the science and technological advances evolve over the term of the award. Provide details regarding how decisions will be made, voting procedures, and how conflicts will be resolved. Outline policies and procedures for reporting and publishing results and sharing data. Describe the plan to provide a publicly accessible website devoted to Center activities, services, research opportunities, publications and linking to data and resource availability. Include contact information to allow external investigators to propose collaborations.

Outline plans for maintaining open lines of communication and information sharing among the Projects and Cores and staff of the Center, as well as with NIAID and external collaborators. Describe plans for working groups, informational webinars, retreats, and annual SAB meetings. Outline the expertise that will be sought from the members of the SAB, but do not name SAB members in the application. Describe the allocation of Scientific Core and Research Project resources to support both internal projects and external collaborations solicited through the Workforce Development Core CDAs and (if applicable) the Service and Resource Core.

Describe a plan including proposed timelines to shift the Center activities in response to a public health emergency or outbreaks.

Letters of Support: Provide letters of support for the leadership qualifications and experience of the Administrative Core leaders.

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.

Workforce Development Core When preparing your application, use Component Type 'Workforce Dev Core.' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

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

PHS 398 Cover Page Supplement (Workforce Development Core) Follow standard instructions.

Research & Related Other Project Information (Workforce Development 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) (Workforce Development 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 (Workforce Development Core)

Budget (Workforce Development Core) Budget forms appropriate for the specific component will be included in the application package.

Include funding for Career Development Awards (CDAs) to support research to obtain preliminary data, perform feasibility studies, support new and emerging science, and facilitate new collaborations among researchers in complementary areas of science in support of NIAID research priorities. Pilot projects are expected to be funded for 12-month periods, with the option for renewal/continuation. It is expected that approximately 10% of the overall Center budget will be dedicated to funding CDAs.

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 (Workforce Development Core) Specific Aims: Describe how the Core will help foster the next generation of structural biologists studying infectious diseases.

Research Strategy: Without duplicating information in the biosketch, describe the general expertise of the Core personnel, their roles and responsibilities, and how the Core will be managed. Describe in detail the activities that the Core will carry out to support the mentoring and research efforts of students, postdoctoral fellows and early-career researchers associated with the Center. Describe what types of financial support will be provided to these individuals and the process for requesting, reviewing, and awarding funding requests.

Describe in detail how the Collaborative Development Award (CDA) program will operate to solicit, review, and manage collaboration requests from external researchers, including the use of a publicly accessible website. Outline how CDA funding decisions will be made in consultation with NIAID staff, including target allocations and guidelines for selecting between early-career vs. "new to infectious disease" applicants. Include a tentative plan for issuing CDAs during the first year of award, including potential topics.

Describe other activities dedicated to educational outreach for the research community.

Applications that do not include a specific plan for administering the CDA program, including strategies for outreach and solicitation of collaborations, will be considered non-compliant and will not be reviewed.

Letters of Support: Include only if they provide evidence of institutional financial support.

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 (Workforce Development 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.

Scientific Cores When preparing your application, use Component Type 'Scientific Core.' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Scientific Cores) Complete only the following fields:

PHS 398 Cover Page Supplement (Scientific Cores) Follow standard instructions.

Research & Related Other Project Information (Scientific Cores) Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

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

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

Project/Performance Site Location(s) (Scientific Cores) List all performance sites that apply to the specific component.

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

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

Budget (Scientific Cores) Budget forms appropriate for the specific component will be included in the application package.

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

PHS 398 Research Plan (Scientific Cores) Specific Aims: Outline the role of the Core in supporting the overall goals of the Center.

Research Strategy: Without duplicating information in the biosketch, describe the expertise of the Core personnel and how the Core will be managed. Describe the locations of Core facilities, whether certain aspects of the facilities will be shared resources, and how activities will be coordinated across distinct sites if applicable. Describe in detail the cutting-edge technologies to be developed and the services, and resources that the Core will provide to support individual Research Projects as well as external collaborations, including new collaborations solicited through CDAs or (if applicable) the Service and Resource Core. Describe the wide range of services to be provided, including X-ray crystallography, Nuclear Magnetic Resonance, cryo-electron microscopy/tomography, computational methods and modeling, artificial intelligence technologies, bioinformatics, etc. Outline how research needs will be prioritized, tracked, and accommodated across the different Research Projects and external collaborations.

Letters of Support: Provide letters of support only if necessary to document access to a shared resource.

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 (Scientific Cores) 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.

Service and Resource Core When preparing your application, use Component Type 'Serv Resource Core.' All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Service and Resource Core) Complete only the following fields:

PHS 398 Cover Page Supplement (Service and Resource Core) Follow standard instructions.

Research & Related Other Project Information (Service and Resource 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) (Service and Resource 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 (Service and Resource Core)

Budget (Service and Resource Core) Budget…