PAR-28-090-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)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

Fogarty International Center (FIC)

National Cancer Institute (NCI)

Funding Opportunity Title

Centers for AIDS Research (CFAR) and Developmental Centers for AIDS Research (D-CFAR) (P30 Clinical Trial Not Allowed)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of

PAR-23-116

Reissue of

PAR-23-117

Related Notices

Funding Opportunity Number (FON)

PAR-28-090

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, 93.837, 93.233, 93.838, 93.839, 93.840, 93.865, 93.121, 93.307, 93.310, 93.393, 93.989, 93.394, 93.395, 93.396, 93.279, 93.866, 93.242, 93.847, 93.361

Notice of Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to invite applications for the Centers for AIDS Research (CFAR) and Developmental Centers for AIDS Research (D-CFAR) programs to provide administrative and shared research support to enhance HIV/AIDS research. CFARs provide infrastructure, expertise, resources, and services not readily obtained through other funding mechanisms. The program emphasizes interdisciplinary collaboration across all areas of HIV/AIDS research.

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 16, 2026

Open Date (Earliest Submission Date)

April 25, 2027

The following table includes NIH standard due dates marked with an asterisk.

May 25, 2027 *

May 25, 2027 *

Not Applicable

March 2028

May 25, 2028 *

May 25, 2028 *

Not Applicable

March 2029

May 25, 2029 *

May 25, 2029 *

Not Applicable

March 2030

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 26, 2029

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 AIDS Research (CFAR) program, inclusive of the Developmental CFAR (D-CFAR), are designed to enhance synergy and coordination among independent research laboratories by sharing resources, supporting emerging research opportunities, and promoting efficiencies. They will continue and expand support for implementation science research, including efforts related to the Ending the HIV Epidemic (EHE) in the United States (U.S.) Initiative. These Centers aim to add value to NIH HIV/AIDS research at applicant institutions by supporting collaborative activities that cannot be easily funded through standard research awards, and by fostering research aligned with NIH Unified Funding Strategy.

The CFAR and D-CFAR programs accomplish their mission by:

While CFARs and D-CFARs serve similar missions, a D-CFAR is designed to support recipients by identifying gaps and opportunities for improvement to enhance future competitiveness for a standard CFAR. It facilitates the development of collaborations, the decision making of Core facilities essential for HIV/AIDS research and the strengthening of areas that may hinder a successful standard CFAR application. D-CFARs cannot be renewed but can compete for a standard CFAR award. A D-CFAR award is not a prerequisite to applying for a standard CFAR.

It is highly recommended, but not required, that applicants confer with the Scientific/Research Contact to discuss planned strategies for developing a CFAR or D-CFAR application to ensure alignment with NIH scientific priorities and available resources.

Hereafter, in this notice of funding opportunity (NOFO), "CFAR" applies to both CFAR and D-CFAR applications with additional details for D-CFAR noted where applicable.

CFAR Structure The overall structure of the CFAR is designed to support the HIV/AIDS researchers at the applicant institution(s) in the conduct of their research projects, interact with a variety of organizations to promote collaborations that serve the applicant institution, and create linkages for promoting additional HIV/AIDS research in key areas identified by the scientific community.

Cores Administrative Core - Responsible for managing, coordinating, and overseeing all CFAR activities, monitoring progress, and ensuring that the project goals are met. This Core coordinates the collaborative efforts and interaction among the Cores, Scientific Working Groups, and collaborating partners.

Advisory Committees (optional) – Committees provide guidance and feedback that are coordinated by the Administrative Core which can include:

Developmental Core - Provides short-term funding (e.g., 1-2 years) for HIV/AIDS-specific research awards and mentoring for early career investigators and investigators new to the HIV/AIDS research field.

Advanced Technology Core(s) - Provides specialized equipment, state-of-the-art emerging technologies, training, unique services, quality control, and expertise and/or advice for research activities that are not otherwise accessible for HIV/AIDS research through existing resources at the institution(s).

Clinical Science Core(s) - Provides resources for HIV/AIDS translational research among collaborating clinical, social and behavioral, and basic scientists.

Activities that will not be supported by a CFAR Clinical Science Core include normal patient care, such as screening of clinical specimens, diagnosis, treatment, and rehabilitation.

Implementation Science (IS) Core(s) - Provides resources to enable institutions to make significant contributions to the field of implementation science, for example, activities to support the EHE Initiative. The Core should serve a growing need for IS expertise, consulting services, and capacity building in the wider HIV research field. The Core supports interdisciplinary collaborations and research that studies strategies to adopt, disseminate, and integrate evidence-based health interventions into practice to improve and sustain individual and population health in HIV treatment, prevention, and cure.

Additional Core(s) (Optional) Additional Cores may be proposed if they are needed to advance the local HIV/AIDS research efforts. Some examples of additional cores could also include Social/Behavioral, Biostatistics, Data Science, Artificial Intelligence (AI), Prevention, HIV Cure, or Bioinformatics. Additional Cores may be of a nature other than advanced technology or clinical.

Scientific Working Group(s) A Scientific Working Group (SWG) is defined as a group of investigators (HIV and non-HIV) who share a common interest in a specific area of scientific focus that is critical to addressing the HIV epidemic but is a gap or underdeveloped at the CFAR institution(s).

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

Cores not specifically targeting HIV/AIDS research.

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

Renewal - Renewal applications can only be submitted for awards funded through PAR-23-116 and their prior issuance.

Resubmission

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

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project and are dependent on the applicant institutions' NIH HIV/AIDS-funded research base (FRB) and whether the application is for a CFAR or a D-CFAR. See Section III.3 for additional information on eligibility.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 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. 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.

Applicant organizations must choose to submit either a D-CFAR application or standard CFAR application. A D-CFAR award is not a prerequisite to apply for a standard CFAR.

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:

CFAR-specific Eligibility Requirements One CFAR Award per Institution No institution may submit or participate as a performance site for more than one CFAR or D-CFAR award concurrently. An institution that is part of a multi-institutional CFAR or D-CFAR application or award may not be listed as a multi-institutional participant in another CFAR application or apply as a single institutional CFAR or D-CFAR. Independent campuses that are part of a large multiple city university are considered to be separate institutions (normally identified by having a unique entity identifier (UEI) or NIH IPF number), and each may submit one application.

Multi-institutional CFAR Two or more institutions may submit an application for a single CFAR or D-CFAR award. The institutions do not need to be in the same geographical area if the applicant can demonstrate a feasible plan for collaborative research networks using CFAR or D-CFAR Cores across all institutions.

Cores Outside of the CFAR institution With appropriate justification, CFAR or D-CFAR awards may support a Core at an institution that is not part of the CFAR or D-CFAR if it provides a unique resource.

NIH HIV/AIDS Funded Research Base (FRB) Institutions/Organizations with a HIV/AIDS FRB of $10M annually (minimum) are eligible to apply for a CFAR. Amounts in excess of $10M will result in a larger base award. The NIH HIV/AIDS FRB is defined as the amount of Total Cost funding from NIH for one fiscal year (October 1 to September 30) preceding the calendar year of application submission. Funding amounts for Tier levels will be confirmed at the time the competing award is made. The NIH HIV/AIDS FRB is compiled from data provided by the NIH Office of AIDS Research. Applicants can request the FRB from the Scientific/Research Contact.

D-CFARs qualify for one funding level. Standard CFARs qualify for three tiers of funding based on the FRB for the institution.

The FRB includes NIH peer-reviewed HIV/AIDS research grants, program projects, and cooperative agreements utilizing the following mechanisms only: DP1, DP2, DP5, PF5, R00, R01, R03, R15, R21, R24, R33, R34, R35, R36, R37, R56, R61, RF1, RM1, SC1, SC2, SC3, U01, U10, U24, U34, UF5, UH2, UH3, UG3, and K series awards. The following mechanisms or components of these mechanisms may be considered based on whether or not the award or component involves primarily research activity: KL1, KL2, N01, P01, P30, P50, P60, PM1, U19, U54, UG1, UM1, UM2 and RC series grants.

Conditions to the NIH HIV/AIDS FRB:

Multi-institutional CFAR applications may combine the NIH HIV/AIDS FRBs to meet the eligibility criteria for this funding announcement. CFARs that include a distant institution for a core component may not use the FRB of that institution if they are not including all of the NIH HIV/AIDS investigators at that institution as part of the CFAR.

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

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NA

Required

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Optional

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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 instructions:

Project Summary/Abstract: Applicants should clearly indicate in the abstract if the application is for a CFAR or D-CFAR award.

Facilities and Other Resources: Applicants should clearly demonstrate their institution's commitment to the proposed CFAR. For proposed CFARs with multiple Cores and investigators in different locations, provide a plan for communication among the various locations, plans for transportation of specimens, data and results among major locations, especially those located outside of the United States.

Other Attachments: Applicants must provide the following additional material specified below. Each attachment should be uploaded as a separate PDF using the indicated filename.

NIH HIV/AIDS FRB and non-FRB investigators at the institution(s): This attachment must be titled "FRB and non-FRB HIV/AIDS Investigators". For this attachment, applicants must request this from the Scientific/Research Contact. Describe how investigators plan on participating in the CFAR. Include a justification for why any investigators listed on the FRB are not participating as CFAR members. Following the FRB provided spreadsheet, applicants must also indicate the names of investigators at their institution(s) who will become part of the CFAR but who were not included in the FRB spreadsheet to show other NIH and non-NIH funded HIV/AIDS investigators who will participate in the CFAR.

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.

New applications must use the base total cost amount award for the Tier level in which the applicant is eligible as noted in Section III. Renewal applications may request budget increases above their qualified Tier level. Applicants should follow the NIAID Financial Management Plan when developing budgets for the CFAR for the competing year and out years.

Applicants must consult with Program to request increases over the Tier level for any or all years prior to application submission.

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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the specific aims of the overall CFAR or D-CFAR, as appropriate, and outline how the different Cores will contribute to these aims.

Instructions in this notice of funding opportunity (NOFO) hereafter that mention "CFAR" apply to both CFAR and D-CFAR applications. Specific instructions for D-CFARs are noted where applicable.

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. 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.

The Administrative Core budget may include equipment, supplies, support contracts, and other necessary expenses. Budget costs for administrative support must relate directly to the CFAR proposed work. All items should be fully justified for allocation of CFAR funds within the Budget Justification.

Other administrative costs may include those necessary for the central administration and fiscal management of the CFAR, including relevant and reasonable costs for reprints, graphics, and publications for Developmental Core users.

Include travel funds for the CFAR PD(s)/PI(s) and Administrative Core Lead to attend the Annual CFAR Meeting. Include other travel funds for CFAR specific meetings and NIH requested meetings. Travel funds for leadership of Core(s)/SWG(s) may only be included if the purpose is to attend meetings that provide new information or approaches used within the Cores.

The Administrative Core must include funding to plan and host one CFAR Annual Meeting during the project period, recommended to be included in budget years 2 or 3 (not applicable for new CFARs or D-CFARs).

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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:

Describe the specific aims of the Administrative Core, and how the Core will coordinate and manage activities across the CFAR or D-CFAR, as appropriate, and have an impact on the research infrastructure.

Research Strategy:

Describe the role of the Administrative Core in the CFAR as a whole and how the responsibilities of the Core advance the mission and purpose of the CFAR.

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.

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

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

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

Research & Related Other Project Information (Developmental 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.

Other Attachments: Applicants must include a table titled "Previous (or proposed) Recipients of Developmental Awards Table". Renewal applications should describe the outcomes of previously funded developmental projects. The time period should include all years for which the CFAR was funded but not to exceed the most recent ten years. This table should contain information on the CFAR Investigators, the type of investigator, study title, year funded, the total amount of funding, resulting collaborations, resulting awards, and any resulting publications. New applicants should describe potential early career investigators eligible for developmental projects.

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

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

As applicable, include funds for equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds.

Applicants may request support for early career investigator salary for scientific developmental projects.

As applicable, include funds to mentor and support developmental awards for early career investigators to advance HIV/AIDS research and research towards independent funding. Funds may also be used for investigators not in the HIV/AIDS research field to encourage them to explore novel approaches to HIV/AIDS research questions. Applicants may use funds to support programs and mentoring for students and investigators of various career stages.

Travel funds to support early career faculty to attend a scientific meeting are only allowed to present results from their CFAR Developmental Project award.

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 (Developmental Core) Introduction to Application: For Resubmission and Revision…