It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The Developmental Centers for AIDS Research (D-CFARs) program supports research and administrative infrastructure, and translational HIV/AIDS research activities at institutions that receive significant HIV/AIDS funding from NIH Institutes or Centers. The purpose of the D-CFAR is to provide support for applicants ultimately seeking a standard CFAR. A D-CFAR will allow the applicant to develop collaborations, to experiment with Core facilities that may be important to support HIV/AIDS investigators at the institution, and to build and strengthen any deficiencies that might adversely affect an application for a standard CFAR award, which could ultimately lead to the development of a competitive standard CFAR application. The emphasis expected in a D-CFAR application will be the identification and clear description of gaps or deficiencies that would hinder development of a competitive CFAR application, and Core facilities that would reduce or eliminate these gaps. D-CFARs are intended to promote NIH HIV/AIDS research efforts at the D-CFAR institution(s). The proposed D-CFAR priorities should align with the NIH HIV/AIDS priority topics of research for support using AIDS-designated funds (NOT-OD-15-137).

The Centers for AIDS Research program was established in 1988 and renewed through 2021. D-CFARs were incorporated into the CFAR Program in 2000. The mission of the CFAR program and mechanisms for achieving the mission were developed by the CFAR Directors (https://www.niaid.nih.gov/research/centers-aids-research). The D-CFAR program accomplishes this mission by:

• Providing scientific leadership and institutional infrastructure dedicated to HIV/AIDS research
• Promoting development of sustainable multidisciplinary HIV/AIDS research programs at each CFAR institution, and enhancing synergies with additional non-CFAR partner institutions, including minority institutions, state and local health departments
• Stimulating scientific collaboration in interdisciplinary and translational research, through the facilitation of research collaborations within and among CFARs, and supporting HIV/AIDS research networks
• Supporting basic, translational, implementation and health policy research to facilitate the application of research findings to HIV/AIDS prevention and care
• Strengthening capacity for HIV/AIDS research through international collaborations to efficiently and effectively answer important questions related to the global HIV/AIDS epidemic
• Fostering scientific communication, promoting knowledge of research findings and disseminating important research discoveries to scientific and lay communities
• Sponsoring HIV/AIDS-related training and education as well as providing opportunities for career development
• Developing the next generation of scientific leaders in HIV/AIDS research through focused mentoring, career development and funding support to early career investigators
• Engaging with the NIH and affected communities to prioritize and focus HIV/AIDS research
• Facilitating technology transfer and development through promotion of scientific interactions between CFARs
• Supporting research on the prevention and treatment of HIV infection in underserved domestic populations and those who experience health disparities, especially in communities at high risk for HIV infection
• Leveraging additional HIV/AIDS funding from CFAR host institutions and through philanthropy
• Coordinating responses to NIH emerging research priorities

Added value. D-CFARs are expected to provide added value to the applicant institution's HIV/AIDS research efforts through support of activities that cannot easily be provided through standard research awards with the ultimate goal of strengthening the Center to be competitive as a standard CFAR. The added value contribution that the proposed D-CFAR will make at the institution(s) should go beyond what would be expected from the pre-existing HIV/AIDS funded research. D-CFARs should promote and encourage activities that enhance collaboration and coordination of research that aligns with the NIH HIV/AIDS priority topics for AIDS-designated funds.

Some examples of added value include:

• Developmental Core awards resulting in collaborations, publications, or successful major research grants, especially among early career investigators and investigators new to the field of HIV/AIDS
• Evidence of an increase in multidisciplinary research and publications
• Evidence of D-CFAR enhancement and support of existing programs at the award institution
• Research activities focused on prevention, treatment and implementation science questions in high-risk and hard-to-reach populations
• Commitment from the institution for support of D-CFAR activities
• Mentoring early career investigators in the HIV/AIDS research field and facilitating the transition to independence
• Promoting and supporting new collaborations designed to move the HIV/AIDS field forward through D-CFAR-sponsored meetings and activities
• Increase in percentage of NIH funded HIV researchers supported by the D-CFAR

Scientific and fiscal flexibility. D-CFARs will use an annual strategic planning process to provide guidance and oversight of scientific and fiscal flexibility. D-CFARs are responsible for using their resources to meet the needs of their investigators. A D-CFAR has the authority to re-allocate resources according to the D-CFAR operating policies and procedures proposed in the application. D-CFARs have authority to change the structure and funding of cores through additions or eliminations, as long as the minimum required cores are maintained. D-CFARs may leverage other resources in support of HIV/AIDS research. D-CFAR Cores may be supported totally, or in part, by D-CFAR funds. Applicants are encouraged to develop creative collaborations to improve utilization of existing resources.

NIH-funded HIV/AIDS investigators at the applicant institution(s). The aims of the Cores and the services they provide should address the needs of HIV/AIDS investigators at the applicant institution(s) and be inclusive of the full range of HIV/AIDS science funded at that institution(s). The NIH-funded HIV/AIDS research base spreadsheet made available by the NIH should be used to ensure that the D-CFAR supports all NIH HIV/AIDS investigators at an institution.

Collaborations with community groups, organizations and other institutes. Applicants are encouraged to explore collaborative, multi-institutional linkages with international and domestic sites and institutions, and, Historically Black Colleges and Universities (HBCUs). Examples of linkages include mentoring, collaborating, and training. Such linkages foster research training and collaborative studies and are able to meet needs that cannot be easily addressed by other funding mechanisms. Additionally, D-CFARs are encouraged to work with local and state health departments and community organizations (e.g. CBOs, community health clinics, faith-based organizations, etc.) as they conduct research on aspects of the local HIV epidemic. Coordination with international programs funded by the Fogarty International Center (FIC) is encouraged. D-CFARs can establish inter-CFAR collaborations where investigators from different CFARs/D-CFARs collaborate with each other in scientific areas of common interest to achieve economies of scale, to share unique resources and expertise, and to expand collaborative activities between CFARs/D-CFARs, especially in areas that cannot be studied at a single CFAR/D-CFAR site. Examples of inter-CFAR collaborations can be found on the CFAR website (https://www.niaid.nih.gov/research/cfar-collaborations). D-CFARs may expand these activities to achieve the objectives of the award. Examples include, community outreach, development of scientists from underrepresented populations (NOT-OD-20-031) in HIV/AIDS research, HIV/AIDS research communications to non-scientists, D-CFAR-sponsored seminars and meetings, identifying additional support for ongoing NIH programs not planned in the initial award, additional research collaborations, and other activities that meet the HIV/AIDS research needs of applicant institutions.

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

Cores and Core services provide support of specific functions that facilitate HIV/AIDS research at the D-CFAR institution, therefore Cores must specifically target HIV/AIDS research.

Administrative Core

The D-CFAR Administrative Core will be responsible for managing, coordinating, and overseeing the entire range of D-CFAR activities, monitoring progress, and ensuring that the project milestones are being met and implemented effectively within the proposed timelines. The Administrative Core must provide both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among the Cores and Scientific Working Groups. Additionally, the Core should coordinate and facilitate communication with other collaborating partners.

Developmental Core

The D-CFAR Developmental Core provides short-term funding for HIV/AIDS specific research awards and mentoring for early career investigators. The purpose of Developmental Core awards is to support early career HIV/AIDS investigators and investigators new to the HIV/AIDS research field. These projects may encompass research to obtain preliminary data for an R01 application, perform feasibility studies, support new and emerging science in HIV/AIDS research, and facilitate new collaborations among faculty or institutions in diverse areas of science in support of high priority HIV/AIDS research. Developmental Core projects proposing clinical trials will not be permitted under this FOA.

Basic Science Core(s)

The D-CFAR Basic Science Core provides specialized/dedicated equipment, training, unique services, quality control, and expertise/advice for research activities that cannot easily be funded through standard research projects. An important focus of the Core should be to drive innovation in HIV/AIDS basic research by providing state-of-the-art emerging technologies that might not otherwise be accessible for HIV/AIDS research through existing resources at the institution(s). Standard services may also be included if evidence can be provided that the services are in demand and will be highly utilized based on the needs of D-CFAR members. The Basic Science Core should provide economies of scale and should foster collaboration between basic and clinical investigators. The Basic Science Core does not substitute for resources that are obtainable commercially, or replace existing resources normally supported by individual research grants. The Core should have a clear focus, contribute to translational research, and demonstrate added value. When the Core coordinates access to other institutional core services, sufficient justification should be provided on why this approach provides added value to D-CFAR members.

Clinical Science Core(s)

The D-CFAR Clinical Science Core provides resources for HIV/AIDS translational research among collaborating clinical, social and behavioral, and basic scientists. The Clinical Science Core involves direct interaction with human subjects (e.g., a single blood draw, sample and data collection, use of behavioral study instruments) or indirect interaction with human subjects (e.g., developing a database or repository for clinical specimens). This Core provides services for investigators to develop appropriate study designs, study protocols, informed consents, and assist in obtaining requirements for human subjects research. Activities that will not be supported by a D-CFAR Clinical Science Core are normal patient care, including screening of clinical specimens, diagnosis, treatment, or rehabilitation.

Additional Core(s)

Additional Cores may be proposed if they are needed to advance local HIV/AIDS research efforts, for example, Social/Behavioral, Biostatistics, Bioinformatics, Implementation Science, or Genomics/Proteomics. These Cores may be of a nature other than basic science or clinical.

Scientific Working Group(s)

A Scientific Working Group (SWG) is defined as a group of investigators (HIV or 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 D-CFAR institution. The research area should not already be well-established at the D-CFAR institution(s). The goal of a SWG is to promote multi-disciplinary collaborations that result in the successful applications for new HIV/AIDS research awards. The SWGs should fall within the NIH HIV/AIDS priority areas.

NIH D-CFAR Management and Oversight

The D-CFAR program is co-funded by multiple NIH Institutes and Centers, however, NIAID administers the awards. Thus CFAR awards will be scientifically and programmatically managed by the NIH CFAR Steering Committee (https://www.niaid.nih.gov/research/cfar-contactscfar-contacts). D-CFARs are encouraged to collaborate with other NIH funded programs when appropriate.

Programs, resources, and centers highlighted for each co-funding NIH Institute and Center are listed below.

Co-funded Programs: ATN, MACS/WIHS Combined Cohort Study, HIV/AIDS Clinical Trials Networks

FIC: Fogarty HIV Training Program and HIV-related awards under the IRSDA, BIOETHICS TRAINING,BRAIN DISORDERS, Global Health Program for Fellows and Scholars, MEPI Junior Faculty Research Training, Fogarty Emerging Global Leader Award, and Global Noncommunicable Diseases and Injury Research.

NCI: AMC, ACSR, NCI-Designated Cancer Centers

NHLBI: Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC), MACS/WIHS Combined Cohort Study

NIA: Alzheimer's Disease Centers, Centers on the Demography and Economics of Aging, Claude D. Pepper Older Americans Independence Centers, Nathan Shock Centers of Excellence in the Basic Biology of Aging, Resource Centers for Minority Aging Research, Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging, WHO Study on AGEing and adult health (SAGE)

NIAID: HIV/AIDS Clinical Trials Networks, CHAVD, IeDEA, Martin Delaney Collaboratories, Specialized Centers for HIV/AIDS-Related Structural Biology, Program in Structure-Based Drug Design Related to AIDS, TB-RePORT

NICHD: Add health, ATN, PHACS, Population Studies Centers (R24)

NIDA: CTN, HIV/AIDS and SUD Clinical Cohorts, PHACS

NIDCR: PHACS, HVTN, and studies aligned with the HIV/AIDS & and Oral Health Research Program.

NIDDK: Diabetes Research Centers, Digestive Diseases Research Centers, Kidney Disease Centers, Cooperative Centers for Excellence in Hematology, Nutrition Obesity Research Centers, Urologic Disease Centers

NIMH: Brain Bank, NIMH Centers Program, NIMH AIDS Research Centers Program

NIMHD: See co-funded programs

NINR: NINR Research Centers

Applicants are encouraged to contact the Scientific/Research Contact(s) at the end of this FOA to discuss planned strategies for developing a D-CFAR application with respect to how a D-CFAR would enhance the HIV/AIDS research mission of the co-funding NIH Institutes and Centers.

A companion funding opportunity (PAR-20-106) encourages applications for Centers for AIDS Research (CFAR) to support the development of a CFAR application.

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

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

D-CFAR-specific Eligibility Requirements

NIH HIV/AIDS Funded Research Base (FRB)

Institutions/Organizations with a HIV/AIDS FRB of $10M annually (minimum) are eligible to apply for a D-CFAR. The 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. D-CFAR applicants must maintain the required minimum FRB during the year of submission in order to be funded at the requested amount. This applies only to competing applications. The NIH HIV/AIDS FRB is compiled from data provided by the NIH Office of AIDS Research to determine eligibility. Applicants can request the FRB from NIAID.

The FRB includes NIH peer-reviewed HIV/AIDS research grants, program projects, and cooperative agreements utilizing the following mechanisms only: DP1, DP2, DP5, R00, R01, R03, R15, R21, R24, R33, R34, R35, R36, R37, R56, R61, RF1, SC1, SC2, SC3, U01, U10, U19, U24, U34, UH2, UH3, UG3, and K series awards. On a case-by-case basis, the following mechanisms will be considered based on whether or not the award involves primarily research activity: KL1, KL2, N01, P01, P50, PM1, U54, UG1, UM1, UM2 and RC series grants. Excluded from the NIH HIV/AIDS FRB are all funds from any source other than NIH. Additionally, only the amount budgeted directly to an applicant institution(s) will be included for grants over $5M in the FRB.

Multi-institutional D-CFAR applications may combine the NIH HIV/AIDS-funded research of all the investigators at the institutions participating in the proposed D-CFAR to meet the NIH HIV/AIDS FRB eligibility. A D-CFAR applicant cannot use the FRB of an institution that is already part of another CFAR or D-CFAR. D-CFARs that use a distant institution for a core facility may not use the funded research of that institution if they are not including all of the NIH HIV/AIDS investigators at that institution as part of the D-CFAR.

One D-CFAR award per institution

No institution may have more than one D-CFAR or CFAR award concurrently. An institution that is part of a multi-institutional D-CFAR or CFAR application or award may not be listed as a multi-institutional participant in a D-CFAR application. Independent campuses that are part of a large multiple city university are considered to be separate institutions, and each may submit one application.

Multi-institutional D-CFAR

In some cases, two or more institutions that can demonstrate a credible plan for collaborative research networks using D-CFAR Cores may wish to submit an application for a single D-CFAR award. A multi-institutional D-CFAR application must designate a lead institution that will receive the award, should demonstrate sharing in leadership positions, and provide details of agreements regarding coordination and support of Cores and activities at other participating institutions.

Cores outside of the D-CFAR institution

With appropriate justification, D-CFAR awards may support a core at an institution that is not part of the D-CFAR, including a primate facility or a foreign institution that provides a unique resource such as a clinical and/or laboratory site.

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Kumud K. Singh, Ph.D.
Telephone: 301-761-7830
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	30 Pages
Admin Core	12 Pages
Core (use for Developmental, Basic Science, Clinical Science, Additional)	12 Pages
SWG (use for Scientific Working Group)	6 Pages

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of one
• Developmental Core: required, maximum of one
• Basic Science Core(s): required, no maximum
• Clinical Science Core(s): required, no maximum
• Additional Core(s): optional
• Scientific Working Group(s): required, maximum of three

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions. with the following additional instructions

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

Facilities and Other Resources: Applicants should clearly demonstrate their institution’s commitment to the proposed D-CFAR. Examples of the types of institutional commitment at D-CFARs include but are not limited to: level of institutional funding, space allocation, co-funding, endowments, faculty commitments, salary for Core staff, purchase of equipment, and designation of center program status in the institutional bylaws. In addition, for proposed D-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. The attachment should be uploaded as a separate PDF using the indicated filename.

NIH HIV/AIDS Funded Research Base (FRB): Must title this attachment NIH FRB. For this attachment, applicants must use the information contained within the FRB spreadsheet. Applicants should contact NIAID to request this spreadsheet, which contains a list of all investigators receiving NIH HIV/AIDS funding at an applicant's institution (or institutions if a multi-institution application). Applicants should use the spreadsheet to indicate investigators who have formally agreed to participate in the D-CFAR, and the primary type of participation expected. Applicants should develop their own key table to abbreviate the type of participation(s) for each D-CFAR Member (i.e., Core Director = CD, Core User = CU, attends seminars = S, etc.) and indicate the participation type in the first column. Include an explanation at the bottom of the table explaining why investigators with NIH HIV/AIDS funding are not participating as D-CFAR members.

Non-FRB HIV/AIDS Investigators at the institution(s): Must title this attachment Other HIV/AIDS Investigators. Applicants should indicate the names of investigators at their institution(s) who will become part of the D-CFAR but who were not included in the spreadsheet. This table should be developed by the applicant using the same columns as the FRB table to show other NIH and non-NIH funded HIV/AIDS investigators not listed on the FRB who will participate in the D-CFAR.

Existing Core Facilities at the Institution Applying for a D-CFAR Award: Must title this attachment Other Core Facilities. Please list only the NIH-funded cores at the CFAR institution that would be considered as overlap or that the CFAR will leverage. Indicate in your application the extent to which any of your D-CFAR Cores overlap with or leverage other NIH funded core facilities at your institution. (see https://www.niaid.nih.gov/research/cfar-interested-applicants for a suggested format for this information). Provide a justification for your specific Cores based on extent of overlap in the attachment.

Overall Organizational Chart: Must title this attachment Overall Organizational Chart. Indicate the organizational relationship of the D-CFAR to other components of the institution.

D-CFAR Organizational Chart: Must title this attachment D-CFAR Organizational Chart. Indicate the organizational relationship of the Cores, SWGs, and collaborating institutions within the D-CFAR.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

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

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

Research Strategy: Describe the proposed Overall Research Strategy and the strategic planning process of the D-CFAR including the planned approach to ensure competitiveness for a standard CFAR. Develop a plan to evaluate gaps and deficiencies identified at a D-CFAR institution(s). Some examples include provision of Core services, increasing collaborations within the institution(s), providing support for HIV/AIDS investigators, and addressing barriers that inhibit scientific progress. Additionally, explain how the Center will contribute to meeting the overarching goals and objectives, and/or the potential for unique contributions to the overall HIV/AIDS research at the applicant institution(s), Specifically, define the impact that a D-CFAR could have on enhancing HIV/AIDS research at the applicant institution(s) and exerting a sustained influence on the HIV/AIDS research field.

• Succinctly summarize HIV/AIDS science at the institution(s) that justifies the need for D-CFAR support. Address how the D-CFAR will break down barriers, address gaps and deficiencies, and promote HIV/AIDS research at the institution(s).
• Describe how the D-CFAR provides added value to NIH-funded HIV/AIDS research conducted at the institution(s).
• Describe how the overall structure was determined for the D-CFAR including any organizational work or support that contributed.
• Describe the leadership plan for the D-CFAR including the rationale for the leadership structure and how decisions are made within the leadership.
• Discuss and provide plans for the D-CFAR scientific planning and management process
• Demonstrate the D-CFAR’s ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, and produce an economy of scale.
• Describe the unique ways resources that are not part of the D-CFAR structure are incorporated and supported in the D-CFAR.
• Discuss planned strategies for fostering collaboration among HIV/AIDS investigators from divergent disciplines within the proposed D-CFAR.
• Discuss utilization of D-CFAR resources in unique ways to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s).
• Describe plans and illustrate unique ways the D-CFAR will foster community engagement, involvement, collaboration, and outreach in the D-CFAR. Indicate how these may evolve over the award period. A community advisory board (CAB) is not required, but may be one component of an overall community engagement plan and may help to inform community engagement activities. However, a CAB, by itself, is not sufficient to satisfy the need to actively engage the broader community of stakeholders.
• Describe plans for scientific communications, collaborations and outreach with key stakeholders and partners.
• Discuss proposed internal and external advisory committees, and how their input would benefit the D-CFAR functions and success. NOTE: POTENTIAL OR PROPOSED EXTERNAL ADVISORY COMMITTEE MEMBERS SHOULD NOT BE CONTACTED OR NAMED IN THE APPLICATION.
• For applicants proposing multiple institutions to create a D-CFAR, please address the following items:
• Demonstrate an exceptional need to establish collaboration among multiple investigators at each proposed institution
• Provide plans to overcome potential scientific and management barriers associated with multi- institutional collaborations
• Describe specific plans to address any anticipated budgetary challenges in the transfer of funds and resources among participating institutions

Letters of Support: The applicant must provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining:

• Position, authority, and reporting responsibility (on the institution's organizational chart) for the D-CFAR Director
• Financial and other resource support for the D-CFAR that will be provided by the applicant institution(s)

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

When preparing your application, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

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

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

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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 D-CFAR proposed work and be well justified; similarly, budget support of the D-CFAR Administrative Core Director must match the effort associated with the D-CFAR Administrative Core work. All items should be fully justified for allocation of D-CFAR funds within the Budget Justification.

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

Applicants should include travel funds for the D-CFAR Director(s) and Administrator to attend the Annual CFAR Meeting in the Administrative Core budget request. The D-CFAR Director(s) and Administrator are strongly encouraged to attend the Annual CFAR Meeting. Other travel funds that may be requested include other CFAR or D-CFAR specific meetings and NIH requested meetings. Travel funds may not be used for travel to scientific meetings, or advertising and promotion. Additional travel funds beyond the Annual CFAR Meeting attendance must not exceed $40,000 (direct costs) annually. This includes funding for Core Directors to attend meetings that provide new information on technologies or approaches used within the Cores.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

Introduction to Application: For Resubmission 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 D-CFAR and have an impact on the research infrastructure.

Research Strategy: Describe the role of the Administrative Core in the D-CFAR as a whole and how the responsibilities of the Core advance the mission and purpose of the D-CFAR.

• Describe the scientific management process used to determine the initial selection of Cores and SWGs. Describe the plans for periodic review and evaluation of Cores and SWGs, and how decisions will be made to increase or decrease or maintain resources, and/or entire Cores in an effort to manage the D-CFAR to meet stated needs. Describe the plan for identification of new Cores for the D-CFAR.
• Provide a plan for evaluating the progress and utilization of Cores, criteria for increasing or decreasing funding of these Cores, and process for adding or deleting Cores during the course of the award.
• Describe how the Administrative Core staff will ensure success of the primary functions of the Core, such as overall D-CFAR program management, including budget and resource allocation, prioritization, and management. Describe the plans for communicating information between the Center and NIAID staff.
• Provide a plan for how HIV/AIDS researchers will be informed of the Core services available and how the process for obtaining support will be articulated to the end user. Describe the communications plan for all D-CFAR activities to D-CFAR members and those outside the D-CFAR.
• Describe plans to expand the membership of HIV researchers funded by NIH at the D-CFAR institution(s) but not yet supported by the D-CFAR.
• Describe the policies and procedures for the proposed D-CFAR, including procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet research needs.
• Describe the plans for soliciting ideas for D-CFAR-sponsored conferences, seminars, workshops, and other activities.
• Provide a management and oversight plan for all Administrative Core functions and activities, including coordination and oversight of Human Subjects Protections and Animal Welfare Assurance for the D-CFAR.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

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

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

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

The Developmental Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of D-CFAR funds within the Budget Justification. Any budget requested for support of the Developmental Core Director must match the effort associated with the Developmental Core work conducted by the Developmental Core Director. Applicants may request support for early career investigator salary for scientific developmental projects.

Applicants may include travel funds to support early career faculty to attend a scientific meeting to present the results from their D-CFAR Developmental Project award. D-CFAR funds cannot be used to provide travel scholarships for investigators without a D-CFAR developmental award.

Applicants should budget funds to support developmental awards that stimulate interest in HIV/AIDS research. These funds may be used by early career investigators in the HIV/AIDS field to support 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 mentoring of early career investigators in order to achieve success in applying for external research funding. Senior investigators in HIV/AIDS research field are not eligible for developmental project awards except in rare circumstances and must have prior approval from NIH Program Staff.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

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

Specific Aims: Describe the specific aims of the Developmental Core and how the Core will enhance, increase, improve or stimulate the HIV/AIDS research conducted at the institution(s) and how it will support the next generation of HIV/AIDS researchers.

Research Strategy: Describe the role of the Developmental Core in the D-CFAR as a whole, and how the responsibilities of this Core advance the mission and purpose of the D-CFAR. Explain the general methods and approaches proposed to accomplish the specific aims, and the rationale for their selection.

• Describe the extent to which the Developmental Core provides added value to NIH-funded HIV/AIDS research conducted at the institution(s).
• Describe how all types of developmental awards (e.g. pilot awards, vouchers, micro-awards, etc.) will be solicited, reviewed, awarded, administered, and evaluated for progress and outcomes. Note that applications proposing clinical trials for Developmental Core research projects will not be funded.
• Describe the process used by the Developmental Core for prioritizing opportunities for funding and the scope of the HIV/AIDS science.
• Determine any current gaps in the support of early career investigators, and describe the plans to overcome these gaps, including the activities undertaken by the Core, and working with other D-CFAR Cores and SWGs, to enhance their ability to secure independent funding for their research.
• Describe how institutional support will contribute to achieving the aims of the Core.
• Describe the process to develop a D-CFAR mentoring plan to support early career investigators, including those who are not successful in obtaining developmental project funding. Additionally, determine any deficiencies in current mentorship and how the D-CFAR will address these deficiencies.
• Describe any additional activities supported by the Core to facilitate the transition to independence for early career investigators.
• Provide a plan for use of first year developmental funds, including a list of potential topics for developmental projects.
• Describe the policies and procedures for the proposed Developmental Core, including for example, how decisions are made, frequency of internal progress reporting, how the overall Core progress will be assessed, including the strategic planning process, and process for reallocating funds within the Core as needed.
• Describe how the Developmental Core will monitor and ensure compliance of all developmental projects involving human or animal subjects, and obtain the appropriate approvals (i.e., annual IRB approvals, FWA, IACUC, human subjects research training, etc. in domestic and foreign institutions).
• Describe procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet research needs.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

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

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

Other Attachments:

Core Utilization Table. Please title this attachment [Name of basic science core] Core Utilization Table. Applications should include a table containing information on potential or current Basic Science Core users and percent use by each. This table should contain information on the D-CFAR Investigator, title of the grant or study, the NIH grant number, NIH Program, type of support provided, and the percent use. See sample formats at https://www.niaid.nih.gov/research/cfar-interested-applicants.

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

The Basic Science Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of D-CFAR funds within the Budget Justification. Any budget requested for support of the Basic Science Core Director must match the effort associated with the Core management. The D-CFAR may support technical staff to provide D-CFAR services in Core facilities.

In the budget justification section, applicants should list any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

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

Specific Aims: Describe the specific aims of the Basic Science Core and how the activities of the Core will expand and promote the research priorities of the D-CFAR beyond what is currently available. Describe how the Core services provided will enhance, increase, improve or stimulate the HIV/AIDS research conducted at the institution(s).

Research Strategy: Describe the role of the Basic Science Core within the D-CFAR as a whole, and how the responsibilities of this Core advance the mission and purpose of the D-CFAR. Explain the general methods and approaches proposed to accomplish the specific aims, and the rationale for their selection.

• Describe the overall purpose of the Core and provide a management plan. This should include, for example, day-to-day operations, scientific communications, training, and efforts to monitor quality control, procedures, and safety.
• Describe the extent to which the Basic Science Core provides added value to NIH-funded HIV/AIDS research conducted at the institution(s) including providing economies of scale.
• Describe the strategic planning process to evaluate gaps and deficiencies in the current infrastructure and how the provision of Core services may bridge these gaps and enhance HIV/AIDS research at the institution(s).
• Describe how the Core will develop and/or incorporate state of the art, innovative technologies and resources that will advance basic science research in the HIV/AIDS field.
• Describe how the Core will provide NIH researchers with the tools and training necessary to utilize state of the art, innovative technologies and resources available through the Core as appropriate.
• Demonstrate the Core’s ability to support the research base, which can include NIH funded projects that may be supported by the Core.
• Indicate how early career investigators or faculty new to the HIV/AIDS research area will benefit from Core services.
• Describe how institutional support will contribute to achieving the aims of the Core, if provided.
• Cite NIH-specific programs supported by the Core and how the Core will provide support.
• Describe the plans of the Basic Science Core to foster synergy with other D-CFAR Cores and SWGs, and enhance HIV/AIDS research collaborations.
• Describe the process used by the Basic Science Core for prioritizing workload and Core usage with respect to evolving scientific priorities at the applicant institution.
• Describe the policies and procedures for the proposed Basic Science Core, including for example, how decisions are made, frequency of internal progress reporting, the strategic planning processes, and process for reallocating funds within the Core as needed.
• Describe how the Core will measure progress and evaluate outcomes.
• Describe procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet research needs.
• Describe how Cores with partial D-CFAR funding (e.g., leveraging existing Cores funded by NIH) will be used to enhance the research of D-CFAR investigators and highlight added value beyond what already exists at the institution.
• Describe how coordinating access to other institutional cores provides added value, especially if this is the primary approach to providing Core services.
• Describe how the Basic Science Core will monitor and ensure Core User compliance with Human Subjects Protections and/or Animal Welfare Assurance in the processing of human or animal tissues, samples or other research data obtained through multiple sources, including ongoing funded trials, research or D-CFAR repositories.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

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

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

Other Attachments:

Core Utilization Table. Please title this attachment [Name of clinical science core] Core Utilization Table. Applications should include a table containing information on potential or current Clinical Science Core users and percent use by each. See examples at https://www.niaid.nih.gov/research/cfar-interested-applicants.

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

The Clinical Science Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of D-CFAR funds within the Budget Justification. Any budget requested for support of the Clinical Science Core Director must match the effort associated with the Core management. The D-CFAR may support technical staff to provide D-CFAR services in Core facilities.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

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

Specific Aims: State the Specific Aims of the Clinical Science Core and describe how the activities of the Core will expand and promote the research priorities of the D-CFAR beyond what is currently available. Describe how the Core services provided will enhance, increase, improve or stimulate the HIV/AIDS research conducted at the institution(s).

Research Strategy: Describe the role of the Clinical Science Core within the D-CFAR as a whole, and how this Core advances the mission and purpose of the D-CFAR. Explain the general methods and approaches proposed to accomplish the specific aims, and the rationale for their selection.

• Describe the overall purpose of the Clinical Science Core and provide a management plan. This should include, for example, day-to-day operations, scientific communication, training, and safety.
• Describe the extent to which the Clinical Science Core provides added value to NIH-funded HIV/AIDS research conducted at the institution(s) including providing economies of scale.
• Describe the strategic planning process to evaluate gaps and deficiencies in the current infrastructure and how the provision of Core services may bridge these gaps and enhance HIV/AIDS research at the institution(s).
• Demonstrate the Core’s ability to support the research base which can include NIH funded projects that may be supported by the Core.
• Describe how institutional support will contribute to achieving the aims of the Core, if provided.
• Indicate how early career investigators in the HIV/AIDS research area or faculty new to the HIV/AIDS research area will benefit from Core services, including guidance or training in the development of protocols and regulatory documents for clinical research projects.
• Cite NIH-specific programs supported by the Core and how the Core will provide support.
• Describe the plans of the Clinical Science Core to foster synergy with other D-CFAR Cores and SWGs, and enhance HIV/AIDS research collaborations.
• Describe the process used by the Clinical Science Core for prioritizing workload and Core usage with respect to evolving scientific priorities at the applicant institution.
• Describe the policies and procedures for the proposed Clinical Science Core, including for example, how decisions are made, frequency of internal progress reporting, the strategic planning processes, and process for reallocating funds within the Core as needed.
• Describe how the Core will measure progress and evaluate outcomes.
• Describe procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet research needs.
• Describe how Cores with partial D-CFAR funding (e.g., leveraging existing Cores funded by NIH) will be used to enhance the research of D-CFAR investigators and highlight added value beyond what already exists at the institution.
• Describe how the Clinical Science Core will monitor and ensure Core User compliance with Human Subjects Protections in the processing of human tissues, samples or other research data obtained through multiple sources, including ongoing funded trials, research or D-CFAR repositories.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

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

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

Other Attachments:

Core Utilization Table. Please title this attachment [Name of additional core] Core Utilization Table. Applications should include a table containing information on potential or current Core users and percent use by each. See examples at https://www.niaid.nih.gov/research/cfar-interested-applicants.

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

The Additional Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of D-CFAR funds within the Budget Justification. Any budget requested for support of the Core Director must match the effort associated with the Core management. The D-CFAR may support technical staff to provide D-CFAR services in Core facilities.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

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

Specific Aims: State the Specific Aims of the Core and describe how the activities of the Core will expand and promote the research priorities of the D-CFAR beyond what is currently available. Describe how the Core services provided will enhance, increase, improve or stimulate the HIV/AIDS research conducted at the institution(s).

Research Strategy: Describe the role of the Core within the D-CFAR as a whole, and how the responsibilities of this Core advance the mission and purpose of the D-CFAR. Explain the general methods and approaches proposed to accomplish the specific aims, and the rationale for their selection.

• Describe the overall purpose of the Core and provide a management plan. This should include, for example, day-to-day operations, scientific communication, training, and safety.
• Describe the extent to which the Core provides added value to NIH-funded HIV/AIDS research conducted at the institution(s), including providing economies of scale.
• Describe the strategic planning process to evaluate gaps and deficiencies in the current infrastructure and how the provision of Core services may bridge these gaps and enhance HIV/AIDS research at the institution(s).
• Demonstrate the Core’s ability to support the research base which can include NIH funded projects that may be supported by the Core.
• Describe how institutional support will contribute to achieving the aims of the Core, if provided.
• Indicate how early career investigators in the HIV/AIDS research area or faculty new to the HIV/AIDS research area will benefit from Core services.
• Cite NIH-specific programs supported by the Core and how the Core will provide support.
• Describe the plans of the Core to foster synergy with other D-CFAR Cores and SWGs, and enhance HIV/AIDS research collaborations.
• Describe the process used by the Core for prioritizing workload and core usage with respect to evolving scientific priorities at the applicant institution.
• Describe the policies and procedures for the proposed Core, including for example, how decisions are made, frequency of internal progress reporting, the strategic planning process, and the process for reallocating funds within the Core as needed.
• Describe how the Core will measure progress and evaluate outcomes.
• Describe procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet research needs.
• Describe how Cores with partial D-CFAR funding (e.g., leveraging existing Cores funded by NIH) will be used to enhance the research of D-CFAR investigators and highlight the added value beyond what already exists at the institution.
• Describe how the Core will monitor and ensure Core User compliance with Human Subjects Protections and/or Animal Welfare Assurance in the processing of human or animal tissues, samples or other research data obtained through multiple sources, including ongoing funded trials, research or D-CFAR repositories.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type SWG.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

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

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

Other Attachments:

Scientific Working Group Table. Please title this attachment [Name] Scientific Working Group Member Table. Applications should include a table containing information such as name, title, scientific area of expertise, and time commitment for all potential Scientific Working Group members. See suggested formats at https://www.niaid.nih.gov/research/cfar-interested-applicants.

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Scientific Working Group Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

The SWG budget may include salary support for the SWG Director and the requested amount must match the effort associated with the SWG operations and management. All items should be fully justified for allocation of D-CFAR funds within the budget justification.

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.

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

Specific Aims: Describe the specific aims of the SWG and how the activities of the SWG will expand and promote the research priorities of the D-CFAR. Describe how the SWG will provide contributions to enhance, increase, improve or stimulate the HIV/AIDS research conducted at the institution(s).

Research Strategy: Describe the role of the SWG within the D-CFAR as a whole, and how the SWG will advance the mission, purpose and structure of the D-CFAR. Explain the rationale for selection of the specific scientific focus that is important for the research agenda, but not already well-established at the CFAR institution(s), and the approaches proposed to accomplish the specific aims.

• Describe the overall purpose of the SWG and how it addresses an underdeveloped research area of the institution(s), and provide a management plan that addresses, for example, efforts to reach out to investigators in targeted scientific fields, activities to identify gaps in research in specific HIV/AIDS areas that might benefit from targeted approaches, or plans to bring specific investigators together for sharing of expertise and technique over and above such opportunities provided elsewhere within the Center.
• Describe the extent to which the SWG provides added value to NIH-funded HIV/AIDS research conducted at the institution(s).
• Describe how the SWG will foster synergy and enhance HIV/AIDS research collaborations, including bringing in investigators from outside the field.
• Describe how the SWG will enhance proposed scientific communication, outreach, and training efforts.
• Describe the plans for collaboration of the SWG with D-CFAR Cores.
• Indicate how early career investigators in the HIV/AIDS research area or faculty new to the HIV/AIDS research area will benefit from participation in the SWG.
• Describe how institutional support will contribute to achieving the aims of the SWG, if provided.
• Describe the process used by the SWG for prioritizing the activities of the SWG.
• Describe how progress towards the specific aims will be measured and describe plans to determine when the scientific area of the SWG is established enough to evolve or terminate.
• Describe the process for initiation, evolution, and/or termination of the SWG, any membership requirements, and how the selected members will contribute significantly to the success of the SWG.
• Describe the policies and procedures for the proposed SWG, including for example, how decisions are made, frequency of internal progress reporting, and internal evaluation of progress including strategic planning processes.
• Provide details on how the SWG is multidisciplinary and will assure a high degree of interaction.
• Describe how a SWG will encourage new collaborations and identify potential high impact studies.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date.Section III. Eligibility Information contains information about registration.

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

Important reminders:

All PD(s)/PI(s) and component Project Leads (Core/SWG Directors) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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

For this FOA, note the following:

Reviewers will provide an overall impact score for the entire D-CFAR application. In addition, assigned reviewers will provide individual "criterion scores" for the Overall criteria but not for the other components.

All other components of the Center (i.e., Administrative Core, Developmental Core, Basic Science Core(s), Clinical Science Core(s), Additional Core(s), and Scientific Working Group(s)) will be evaluated but each will receive only one overall numerical score.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the D-CFAR to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the D-CFAR proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a D-CFAR that by its nature is not innovative may be essential to advance a field.

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

Specific for this FOA:

Do the D-CFAR structure and organization enhance proposed scientific communication, outreach, synergy, and training efforts? Does the applicant institution(s) have the necessary HIV/AIDS investigators to warrant a D-CFAR? If needed, is there a plan to increase the number of HIV/AIDS investigators at the D-CFAR? Does the proposed D-CFAR application add value to the HIV/AIDS research community at the applicant institution(s) beyond what could be expected with the pre-existing HIV/AIDS funding base? Is there a significant need for coordination of HIV-related science at the institution(s), and will the D-CFAR serve as the primary coordinating unit for the institution(s)?

Is there a high likelihood that the strategic planning process, Core services proposed, and support for early career investigators will lead to development of a competitive standard CFAR application?

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

Specific for this FOA:

Does the proposed plan for D-CFAR leadership demonstrate sufficient scientific and managerial experience, leadership skills, and time commitment to achieve success of the Center?

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

Specific for this FOA:

Does the D-CFAR adequately describe innovative ways to integrate Cores and Core services, HIV/AIDS and non-HIV/AIDS researchers, and advances in technology in order to achieve the scientific goals stated in the D-CFAR application? Is there sufficient evidence that the D-CFAR application, as proposed, allows for innovative utilization of resources to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s)? Will the D-CFAR strategic plans allow for changes in Core services that will meet the needs of HIV/AIDS investigators for new, rapidly emerging science?

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

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

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

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

Specific for this FOA:

Has the applicant provided a comprehensive strategy to support the NIH-funded researchers at the D-CFAR institution(s)? How robust is the plan to extend D-CFAR support to non-CFAR and investigators new to HIV/AIDS research at the D-CFAR institution(s)? Does the D-CFAR application identify and address gaps or deficiencies that can be overcome by having a D-CFAR to eventually be competitive for a standard CFAR? Does the Center have a plan to determine ways to build and strengthen any deficiencies that might adversely affect an application for a standard CFAR award?

Has the applicant described the management and oversight of the D-CFAR in a manner that reflects an appreciation of the Core services end user needs and the science to be conducted at the application institution? Does the approach create opportunities for support of novel multi-disciplinary research projects and the incorporation of investigators from different scientific disciplines to address high priority HIV/AIDS research topics? Does the application illustrate unique ways to incorporate community involvement, collaboration, and outreach?

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

Specific for this FOA:

Is the institutional support for the proposed D-CFAR appropriate? Has the applicant described methods to leverage and capitalize on existing institutional resources in support of the aims of the D-CFAR? Does the D-CFAR address ways to overcome barriers in order to promote collaboration and enhance the HIV/AIDS research at the institution(s)?

Reviewers will consider the review criteria below in the determination of scientific merit and provide an overall impact score (a single numerical score) for each Core (i.e., Administrative Core, Developmental Core, Basic Science Core(s), Clinical Science Core(s), and optional Additional Core(s)) and Scientific Working Group(s) of the D-CFAR .

All Cores and the Scientific Working Group(s)

Are the Core/SWG services appropriately targeted to HIV/AIDS research? Will the Cores/SWGs have the ability to support the research base, foster synergy, enhance HIV/AIDS research collaborations, provide added value, and produce an economy of scale?

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

Are the concepts, approaches or methodologies, or instrumentation novel? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed? Does the Core/SWG challenge and seek to shift current research?

Are potential problems, alternative strategies, and benchmarks for success presented? If the Core/SWG is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Core/SWG involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Are the Cores/SWGs staffed appropriately to address the workload? Do the Cores/SWGs have plans for prioritization of projects, services and allocation of resources?

Will the scientific environment in which the work will be done contribute to the probability of success? Is the institutional support provided appropriate for the Cores/SWGs? Are the equipment and other physical resources available to the investigators adequate for the Core proposed? Will the Core/SWG benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there adequate institutional commitment, including space, financial support and other resources for Core/SWG activities?

Administrative Core

Does the annual strategic planning process adequately describe the scientific and management plans? Are the policies and procedures appropriate for evaluating Cores and SWGs, for reassigning priorities and for developing and utilizing outcome measurements? Is the plan to prioritize, allocate and manage fiscal resources adequate? Has the applicant provided sufficient detail regarding how Cores/SWGs will be evaluated and the remediation strategy if progress is poor?

Developmental Core

Is the plan to solicit, review, award, administer and evaluate all types of developmental awards (e.g. pilot projects, vouchers, micro-awards, etc.) adequate? Has the applicant provided a plan for engaging early career and non-HIV/AIDS investigators in the D-CFAR community? How well does the Developmental Core address the need for multi-disciplinary research within the HIV/AIDS research field? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Does the Core identify potential gaps in the support of early career investigators? Does the Core have a process to evaluate these gaps and develop a plan to overcome them? Does the Core have a process to develop a mentoring plan to support early career investigators over the award period?

Basic Science, Clinical Science, and Additional Core(s)

Are the management and oversight of the Core adequate to ensure support for the NIH-funded HIV/AIDS researchers at the D-CFAR institution(s)? Is there an adequate plan to engage early career investigators in HIV/AIDS research? Are there clear plans for prioritizing Core utilization? Are policies and procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet their research needs adequate and appropriate? Is there a plan to evaluate Core services proposed to address potential gaps and deficiencies in the current infrastructure?

Scientific Working Group(s)

Is the scientific area proposed by the SWG high priority and does it address a gap or an underdeveloped area at the D-CFAR institution(s)? If the aims of the SWG are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Does the SWG include novel approaches to bring in expertise from outside the field of HIV/AIDS research? Does the SWG membership consist of investigators within the field who traditionally do not collaborate? Is the SWG membership sufficiently scientifically diverse to address the proposed scientific area in terms of current and future research needs of the D-CFAR? Is the structure and organization of the SWG adequate to identify high impact, emerging scientific areas? Is the proposed plan for engaging early career investigators and investigators new to the HIV/AIDS field appropriate?

As applicable for the D-CFAR proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed D-CFAR involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable

Not Applicable

As applicable for the D-CFAR proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Allergy and Infectious Diseases in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Awardee-selected projects that involve clinical studies involving greater than minimal risk to human subjects, behavioral interventions, or vulnerable populations, require prior approval by NIH prior to initiation.

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH ApprovalThe awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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

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

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

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

Candice Beaubien, M.P.H.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3098
Email: [email protected]

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3291
Email: [email protected]

Shimian Zou, Ph.D.
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0074
Email: [email protected]

Basil A. Eldadah, M.D., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: [email protected]

Denise A. Russo, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6871
Email: [email protected]

Hongen Yin, MD, PhD, MHSc
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-0525
Email: [email protected]

Peter J. Perrin, Ph.D.
National Institute of Diabetes and Digestive Kidney Diseases (NIDDK)
Telephone: 301-451-3759
Email: [email protected]

Vasundhara Varthakavi, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2146

Email: [email protected]

Christopher Gordon, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1613
Email: [email protected]

Kristopher Bough, MS, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-337-1372
Email: [email protected]

Rick Berzon, Dr.P.H., P.A.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8949
Email: [email protected]

Geetha Bansal, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: [email protected]

Kumud K. Singh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7830
Email: [email protected]

Roberta Wolcott
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2964
Email: [email protected]

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]

Lynn Rundhaugen
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-480-4546
Email: [email protected]

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: [email protected]

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Diana Rutberg, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Sunshine Wilson
National Institute of Diabetes and Digestive Diseases and Nutrition (NIDDK)
Telephone: 301-827-4670
Email: [email protected]

Pamela G. Fleming
National Institute of Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]

Jane Blom
Fogarty International Center (FIC)
Telephone: 301-496-5710
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.