RFA-AI-27-004-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

Atopic Dermatitis Research Network (ADRN) (U19 Clinical Trial Optional)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of

RFA-AI-19-015

Related Notices

Funding Opportunity Number (FON)

RFA-AI-27-004

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 this notice of funding opportunity (NOFO) is to solicit applications for the Atopic Dermatitis Research Network (ADRN) program. The ADRN program will support Centers that integrate clinical and translational research to improve our understanding and management of atopic dermatitis with emphasis on chronic skin inflammation and the defense mechanisms of the skin.

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

June 29, 2026

Open Date (Earliest Submission Date)

August 24, 2026

September 24, 2026

Not Applicable

Not Applicable

July 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

September 25, 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

Research Objectives Atopic Dermatitis (AD) is a chronic inflammatory pruritic skin disease that affects approximately 11% of children and up to 9% of adults in the United States. AD is associated with defective skin barrier function as well as with several cutaneous immune abnormalities, including type 2 inflammation, decreased expression of antimicrobial peptides, and low numbers of plasmacytoid dendritic cells. These abnormalities, several of which have been previously identified by the Atopic Dermatitis Research Network (ADRN), appear to translate into cutaneous defense defects given that patients with AD are more susceptible to certain viral (e.g., Herpes simplex, coxsackievirus) and bacterial (e.g., Staphylococcus aureus) infections.

The extent of and the mechanisms responsible for the apparent defects in cutaneous host defense seen in AD patients are not fully defined; thus, effective therapies to reverse these defects are absent. Beyond its effects on cutaneous defenses, AD is associated with systemic inflammation and appears to be the first step in the development of other atopic conditions, including food allergy and asthma. Emerging evidence shows the occurrence of bidirectional signaling between the skin and gastrointestinal tracts via communications among the microbiota, epithelium, and immune system at these sites.

The ADRN program will support Centers that integrate clinical and translational research to further improve our understanding of chronic inflammatory and defense mechanisms of the skin by focusing on differences in skin structure/function and immune responses between patients with AD and either healthy individuals or disease controls. Research areas of interest may include, but are not limited to:

The focus of the ADRN is on human disease, with the majority of the proposed research defined as human subjects research or utilizing human material (including primary human cells, biologic samples, and clinical data). Studies using only transformed human cell lines will not satisfy this requirement. The ADRN will support limited animal research based on the need for experimentation that is not possible in humans or with human materials, with inclusion of new approach methodologies (NAMs) that utilize human samples or clinical datasets where feasible in lieu of animal models.

ADRN Research Center Structure Each ADRN Center application will support Research Projects and Cores, as described in Section IV. The allocation of funds to each component is at the discretion of the investigator, but the greatest emphasis should be placed on the Research Projects. The research proposed by an ADRN Center should be highly integrated and synergistic. This may be achieved within single institutions or by multi-institutional applications for research areas of interest to this NOFO.

Steering Committee - PD(s)/PI(s) funded under this program will become members of the ADRN Steering Committee after award that serves as the main governing body for the network. ADRN PD(s)/PI(s) will become members of the SUNBEAM Steering Group after award to contribute AD expertise to the SUNBEAM study.

Applications proposing the following topics will be considered non-responsive and will not be reviewed:

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit $4,520,000 in FY2027 to fund 3-4 awards. This includes up to $250,000 direct costs for the Infrastructure and Opportunity Fund (IOF) and up to $375,000 direct costs for SUNBEAM participation.

Award Budget

Application budgets are not expected to exceed $750,000 direct costs per year, excluding the Infrastructure and Opportunities Fund (IOF) and SUNBEAM participation funds, and need to reflect the actual needs of the proposed project. The IOF budget is not expected to exceed $250,000 direct costs per year. The SUNBEAM participation budget is not expected to exceed $375,000 direct costs per year.

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 not allowed.

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.

An investigator can serve as a PD/PI on only one ADRN application. This includes all PD(s)/PI(s) of a multiple-PD/PI application.

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

Required

Optional

Optional

Required

NA

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) Follow standard instructions.

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.

In single PD/PI applications, the PD/PI must lead at least one Research Project. In multi-PD/PI applications, each PD/PI must lead at least a Research Project or Core; at least one of the PD(s)/PI(s) must lead a Research Project. For ADRN Center grant recipients, leadership roles for each PD/PI must be clear and consistent with requirements.

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.

In single PD/PI applications, the PD/PI is required to commit an overall minimum of 2 person months to all ADRN network activities. In multi-PD/PI applications, at least one of the PD(s)/PI(s) must commit a minimum of 2 person months to all ADRN network activities.

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 Center. Concisely describe the hypothesis or hypotheses to be tested.

Research Strategy: Describe the focus of the ADRN Center. Summarize the overall research strategy for the multi-component application. The multi-component application should be viewed as a coalition of interrelated and synergistic Research Projects, each capable of standing on its own scientific merit, but complementary to one another.

To highlight Center synergy, describe how the individual components will be coordinated and work together to address the overall goals and aims of the Center. Include a schematic overview of the interactions and collaborations among the components and indicate collaborations among members and relevant publications co-authored by members of the Center. Center synergy may also be addressed in other sections of the application, as appropriate. Discuss the role of all Research Projects and Cores and describe how the integration of the individual Research Projects into a single Center benefits the objectives more than pursuing each project independently.

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 the overall administrative efforts, administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses.

Include travel funds for the PD(s)/PI(s) and subproject PD(s)/PI(s) to attend an annual ADRN Steering Committee meeting. The one-day meeting will be held each year in or near Rockville, Maryland.

Infrastructure and Opportunity Fund (IOF): Include funds for the IOF to be awarded to one institution, as selected by the National Institute of Allergy and Infectious Diseases (NIAID) to manage the ADRN IOF. Include direct costs as a single line item on the Other Direct Costs category of the Administrative Core. The IOF budget is not expected to exceed $250K direct costs per year. Provide a breakdown of the collated IOF costs, including costs for a fund administrator for a maximum of 0.5 person-month.

SUNBEAM: Include funds for the SUNBEAM participation funds to be awarded to one institution, as selected by NIAID to manage the ADRN SUNBEAM participation funds. Include direct costs as a single line item on the Other Direct Costs category of the Administrative Core. The SUNBEAM participation budget is not expected to exceed $375K direct costs per year.

Provide a breakdown of the collated cost, including costs for a fund administrator for a maximum of 0.5 person-month.

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) Research Strategy: Describe and justify the operational plan and organizational structure of the proposed multi-component application. Include plans on how the PD(s)/PI(s) will interact and coordinate with Project/Core Leaders to identify and resolve problems and establish a strong collaborative environment for the ADRN Center. Provide a plan that includes a discussion of the structure and roles of administrative staff, including the functions to be performed; how fiscal and other resources will be prioritized, allocated, and managed; how communications, group meetings, and teleconferences will be facilitated; how conflict resolution will be attained; and how research related travel will be managed. Describe how the Core's administrative, management, and leadership capabilities provide for: internal quality control of on-going research, fair communication management of day-to-day program activities, and management of contractual/consortium agreements. Present a leadership succession plan.

Provide a plan to administer the ADRN Infrastructure and Opportunity Fund (IOF) and the SUNBEAM participation funds. Within the plan, address the following: establishing an administrative structure to manage the IOF; demonstrating adequate team expertise with managing complex funding; disbursing and tracking IOF funds and SUNBEAM participation funds under the direction of the Steering Committee in cooperation with the NIAID; implementing plans for interacting with the institutions that will receive IOF and SUNBEAM funds, including establishing consortium and cooperative agreements when applicable; and establishing procedures, formats, and timelines for reporting on the status of SUNBEAM participation and IOF projects and expenditures to the NIAID and the ADRN Steering Committee.

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.

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

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

PHS 398 Cover Page Supplement (Data Stewardship Core) Follow standard instructions.

Research & Related Other Project Information (Data Stewardship 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) (Data Stewardship 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 (Data Stewardship Core)

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

Include funds to support central data management (database establishment, data management and cleaning, data integration, data storage, database security) for the entire ADRN Center for all researchers within the applicant group.

Include funds to support appropriate biostatistical personnel and equipment use effort, as applicable, if the Core will provide statistical design and analysis of data for all Research Projects, Include funds to support the required timely submission of data, meta-data and data analyses to the ImmPort database or other public databases, as appropriate.

Include the percentage of total funds that will be required by the Data Stewardship Core to support each Research Project or Core.

Do not include funds for Data and Safety Monitoring Board (DSMB) 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.

PHS 398 Research Plan (Data Stewardship Core) Specific Aims: List in priority order the broad, long-range activities and services of the proposed Core. In addition, state the Core's relationship to the Center's goals and how the Core relates to the activities of all proposed Cores and all individual Research Projects in the application. Do not propose testing of scientific hypotheses.

Research Strategy:

Describe and justify the overall function of the required Data Stewardship Core. Describe how the services of this Core (including procedures, techniques and quality control) will support all proposed Research Projects and Cores and advance the outcomes from the proposed research Center.

Describe how the Data Stewardship Core will facilitate the harmonization of data collection across all Research Projects and Cores. Discuss how the Core will support data governance by providing appropriate team expertise. Explain the processes, procedures, methods and plans to provide bioinformatics infrastructure support for ADRN Center-wide database establishment, data cleaning and tracking, information management, curation, data monitoring, and quality control. Outline how the Core will support the exchange of information among all ADRN Centers. Detail responsibilities for implementing the Data Management and Sharing Plan (DMSP) and information security services for all researchers within the Center, without duplicating information in the DMSP.

If the Core will provide statistical support to Research Projects and/or Cores, provide general descriptions of statistical approaches to be used to support the statistical design and data analyses for the Research Projects and/or Core(s). However, specific statistical analyses addressing scientific hypotheses should be described within each of the Research Projects and within the Clinical and/or Scientific Core(s), whichever is applicable.

Note: Specific details for clinical trials and studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.

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 (Data Stewardship 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.

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

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

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

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

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

Outline the percentage of total funds that will be required to support each component Research Project that will utilize the Clinical Core.

If a clinical trial or clinical study is proposed, include costs for clinical site monitoring and a medical monitor.

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 (Clinical Core) Research Strategy:

Describe how the Clinical Core will serve at least one of two purposes: 1) recruit and characterize human subjects and collect and track appropriate biosamples in support of at least two Research Projects, and/or 2) support the conduct of one or more pilot clinical trials or clinical studies for at least two Research Projects.

Note: If a clinical trial or study is proposed, its goals and design should be included in a Research Project, as opposed to the Clinical Core.

Note: Specific details for trials and studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.

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 (Clinical 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 Core(s) 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 Core(s)) Complete only the following fields:

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

Research & Related Other Project Information (Scientific 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.

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

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

Outline the percentage of total funds that will be required to support each Research Project that will utilize the Scientific Core.

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 Core(s)) Specific Aims: Discuss the Scientific Core's relationship to the Center's goals and how the Scientific Core relates to two or more individual Research Projects in the application. Do not propose the testing of scientific hypotheses.

Research Strategy: