NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 Centers for AIDS Research (CFAR) 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. CFARs are designed to foster synergy and improve coordination of research, support emerging research opportunities, and promote efficiencies through resources shared by multiple independent laboratories. CFARs are intended to promote NIH HIV/AIDS research efforts at CFAR institution(s). The proposed 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 2017. 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 CFAR program accomplishes this mission by:

• Providing scientific leadership and institutional infrastructure dedicated to HIV/AIDS research
• Stimulating scientific collaboration in interdisciplinary and translational research
• Strengthening capacity for HIV/AIDS research in resource-limited settings
• Fostering scientific communication
• Sponsoring opportunities in support of early career investigators and investigators new to the field of HIV/AIDS
• Promoting knowledge of CFAR research findings and the importance of HIV/AIDS research through community outreach
• Promoting and supporting innovative NIH HIV/AIDS research
• Establishing collaborative research between and among CFARs, and supporting HIV/AIDS research networks
• Facilitating technology transfer and development through promotion of scientific interactions between CFARs
• Supporting research on prevention and treatment of HIV infection in marginalized and hard-to-reach populations, especially inner city, rural poor, and disadvantaged minorities or severely affected populations in low and/or middle income countries (LMIC) countries.

Added value. 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. The added value contribution that the proposed CFAR will make at the institution(s) should go beyond what would be expected from the pre-existing HIV/AIDS funded research. CFARs should promote and encourage activities that enhance collaboration and coordination of NIH HIV/AIDS priority topics of research for support using 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 CFAR enhancement and support of existing programs at the award institution
• Research activities focused on prevention, treatment and implementation science questions in marginalized and hard-to-reach populations
• Commitment from the institution for support of 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 CFAR-sponsored meetings and activities
• Increase in percentage of NIH funded HIV researchers supported by the CFAR
• Development and implementation of a cost recovery system for science cores

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

Collaborations with community groups,organizations and other institutions. Applicants are encouraged to explore collaborative, multi-institutional linkages with international and domestic sites, Historically Black Colleges and Universities (HBCUs) and international institutions. 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. Coordination with international programs funded by the Fogarty International Center (FIC) is highly encouraged. CFARs also 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, especially in areas that cannot be studied at a single CFAR site. Examples of inter-CFAR collaborations can be found on the CFAR website (see https://www.niaid.nih.gov/research/cfar-collaborations). CFARs may expand these activities to achieve the objectives of the award. Examples include community outreach, development of scientists from underrepresented populations (NOT-OD-15-053) in HIV/AIDS research, HIV/AIDS research communications to non-scientists, CFAR-sponsored seminars and meetings, identifying additional support for ongoing NIH programs not planned in the initial award, inter-CFAR collaborations, and other activities that meet the HIV/AIDS research needs of applicant institutions. In addition, CFARs are encouraged to work with health departments and community service agencies as they conduct research on aspects of the local HIV epidemic.

The overall structure of the 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 community.

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

Administrative Core

The CFAR Administrative Core will be responsible for managing, coordinating, and overseeing the entire range of 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.

Developmental Core

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

Basic Science Core(s)

A CFAR Basic Science Cores provides equipment, training, services, quality control, and expertise/advice for research activities that cannot easily be funded through standard research projects. Basic Science Cores should provide economy of scale through use of multiple laboratories and should foster collaboration between basic and clinical investigators. Basic Science Cores do not substitute for resources that are obtainable commercially, or replace existing resources normally supported by individual research grants. Cores should have a clear focus, contribute to translational research and demonstrate added value.

Clinical Science Core(s)

A CFAR Clinical Science Core provides resources for HIV/AIDS translational research among collaborating clinical, social and behavioral, and basic scientists. A 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). Activities that will not be supported by a 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 the local HIV/AIDS research efforts, for example, Social/Behavioral/Prevention, Biostatistical/Bioinformatics, and International. 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 neglected or underdeveloped at the CFAR institution. The goal of a SWG is to promote multi-disciplinary collaborations that result in successful applications for new HIV/AIDS research awards. The SWGs should fall within the NIH HIV/AIDS priority areas.

NIH CFAR Management and Oversight

The 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).

Specific interests of the NIH Institutes and Centers co-sponsoring the CFAR are listed below.

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

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)

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

NIDA: NIDA funded and co-funded programs: CTN, HIV/SU Clinical Cohorts, HIV Clinical Trials Networks, MACS, WIHS, ATN, PHACS

NIAID: HIV/AIDS Clinical Trials Networks, MACS, WIHS, CHAVI-ID, IeDEA, Martin Delaney Collaboratories

NIGMS: Specialized Centers for HIV/AIDS-Related Structural Biology, Program in Structure-Based Drug Design Related to AIDS

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

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

A companion funding opportunity (PAR-17-238) encourages applications for Developmental Centers for AIDS Research (D-CFAR) to support the development of a future CFAR application.

See Section VIII. Other Informationfor award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 IDF 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).

NIH AIDS Funded Research Base (FRB)

Institutions/Organizations with a HIV/AIDS FRB of $10M annually (minimum) are eligible for a CFAR award. Amounts in excess of $10M will result in a larger base award. The NIH HIV/AIDS FRB is defined as the amount of Total Cost funding from NIH for one fiscal year (October 1 to September 30) preceding the calendar year of application submission. CFAR applicants must maintain the required minimum FRB during the year of submission in order to be funded at the requested amount, and applicants eligible for larger base funding must maintain that minimum level in order to qualify for subsequent funding at that level. For example, if an applicant has an FRB in 2017 that makes them eligible for $2.25M in funding, they must maintain the required FRB for funding at the $2.25M funding level in 2018 in order to be funded at that level. This applies only to competing applications.

CFARs qualify for three tiers of funding based on the FRB for the institution.

Tier 1: For institutions with a minimum of $10M, but less than $40M FRB, a CFAR award will use a base of $1.5M total cost in the first year of the competing segment.

Tier 2: For institutions with a minimum of $40M but less than $80M FRB, a CFAR award will use a base of $2.25M total cost in the first year of the competing segment.

Tier 3: For institutions with a minimum of $80M FRB, a CFAR award will use a base of $3M total cost in the first year of the competing segment.

The FRB includes NIH peer-reviewed HIV/AIDS research grants, program projects, and cooperative agreements utilizing the following mechanisms only: DP1, DP2, P01, P50 (only the NIGMS Specialized Centers for HIV/AIDS-Related Structural Biology), R00, R01, R03, R15, R21, R24, R33, R34, R35, R37, R56, R61, SC1, SC2, SC3, U01, U10, U19, U24, 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, PM1, U54, UG1, UM1, UM2 and RC series grants. Excluded from the NIH 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 CFAR applications may combine the NIH HIV/AIDS-funded research of all the investigators at the institutions participating in the proposed CFAR to meet the NIH AIDS-FRB eligibility. A CFAR applicant cannot use the FRB of an institution that is already part of another CFAR or D-CFAR. 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 AIDS investigators at that institution as part of the CFAR. The NIH AIDS FRB is compiled from the NIH Office of AIDS Research and can be requested by the applicant institution to determine eligibility.

One CFAR award per institution

No institution may have more than one CFAR or D-CFAR award concurrently. An institution that is part of a multi-institutional CFAR or D-CFAR application or award may not be listed as a multi-institutional participant in a 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 CFAR

In some cases two or more institutions that can demonstrate a credible plan for collaborative research networks using CFAR cores may wish to submit an application for a single CFAR award. A multi-institutional 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 CFAR institution

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

A button to access the online ASSIST system 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Peter R. Jackson, Ph.D.
Telephone: 240-669-5049
Fax: 301-480-2408
Email: [email protected]

Component Types Available in ASSIST	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: required
• Clinical Science Core: required
• Additional Core: optional
• Scientific Working Group: required, maximum of three

When preparing your application in ASSIST, 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 , with the following additional instructions:

Descriptive Title of Applicant’s Project: Applicants should clearly indicate in the application title that the application is for a CFAR award.

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 CFAR award.

Facilities and Other Resources: Applicants should clearly demonstrate their institution’s commitment to the proposed CFAR. Examples of the types of institutional commitment that have been demonstrated at current 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 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: The following Other Attachments should be included in order to aid in the review of applications.

NIH AIDS Funded Research Base (FRB): Please title this attachment NIH FRB. For this attachment, applicants must use the information contained within the FRB spreadsheet created by the NIH Office of AIDS Research. NIH will provide applicants with 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 CFAR, and the primary type of participation expected. Applicants should develop their own key table to abbreviate the type of participation(s) for each 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 CFAR members.

Non-FRB HIV/AIDS Investigators at the institution(s): Please title this attachment Other HIV/AIDS Investigators. Applicants should indicate the names of investigators at their institution(s) who will become part of the 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 CFAR

Existing Core Facilities at the Institution Applying for a CFAR Award: Please title this attachment Other Core Facilities. Indicate in your application the extent to which any of your cores overlap with other core facilities at your institution already funded by NIH (see https://www.niaid.nih.gov/research/cfar-interested-applicants for a suggested format for this information ) and provide a justification for your specific cores based on extent of overlap.

Overall Organizational Chart: Please title this attachment (pdf file) Overall Organizational Chart. Indicate the organizational relationship of the CFAR to other components of the institution.

CFAR Organizational Chart: Please title this attachment (pdf file) CFAR Organizational Chart. Indicate the organizational relationship of the Cores, SWGs, and collaborating institutions within the 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 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 CFAR and how it 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, describe the impact that a 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 CFAR support.
• Describe how the CFAR provides added value to NIH-funded HIV/AIDS research conducted at the institution(s).
• Describe how the overall structure was determined for the CFAR including any organizational work or support contributed.
• Describe the leadership plan for the CFAR, including rationale for the leadership structure and how decisions are made within the leadership.
• Discuss and provide plans for the CFAR scientific planning and management process.
• Demonstrate the 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 CFAR structure are incorporated and supported in the CFAR.
• Discuss planned strategies for fostering collaboration among HIV/AIDS investigators from divergent disciplines within the proposed CFAR.
• Discuss utilization of CFAR resources in unique ways to achieve the scientific goals of all HIV/AIDS investigators at the participating institution(s).
• Describe the plans for scientific communications, outreach to community (including community based organizations and health departments), collaborations with others, including international researchers and industry.
• Provide evidence that a previous HIV/AIDS center has been productive, has substantially increased HIV/AIDS research at the applicant institution, and has resulted in the identification of gaps and lost opportunities that serves to strengthen the CFAR application. Indicate the beneficial outcomes among the current and potential partners in the CFAR.
• Discuss any proposed internal and external advisory committees, and how their input would benefit the CFAR functions and success.
• For applicants proposing multiple institutions to create a CFAR, please address the following items:
• Demonstrate an exceptional need to establish collaboration among multiple investigators at each proposed institution
• Provide evidence of unique plans, such as the development of organized communications systems to overcome the scientific and management challenges 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 CFAR Director
• Financial and other resource support for the 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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
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 in ASSIST, 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 CFAR proposed work and be well justified; similarly budget support of the CFAR Administrative Core Director must match the effort associated with the CFAR Administrative Core work. All items should be fully justified for allocation of CFAR funds within the Budget Justification.

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

Applicants should include travel funds for the CFAR Administrative Core Director to attend the Annual CFAR Meeting in the Administrative Core budget request. The CFAR Director is strongly encouraged to attend the Annual CFAR Meeting. CFAR funds may be allocated for additional CFAR personnel or investigators to attend meetings held in conjunction with the Annual CFAR Meeting. Other travel funds that may be requested include other CFAR or D-CFAR specific meetings, NIH requested meetings, or site visits at D-CFAR or CFAR sites. 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 CFAR and have an impact on the research infrastructure.

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

• Describe the scientific management process used to determine the initial selection of Cores and SWGs. Describe the plans for periodic review and evaluation of all 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 CFAR to meet stated needs. Describe the plan for identification of new Cores for the 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 the overall 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 CFAR activities to CFAR members and those outside of the CFAR.
• Describe plans to expand the membership of HIV/AIDS researchers funded by NIH at the CFAR institution(s) but not yet supported by the CFAR.
• Describe the policies and procedures for the proposed 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 CFAR-sponsored conferences, seminars, workshops, and other activities.
• Describe how the Administrative Core will oversee the processes and reporting of the recharge system from the applicable Cores.
• 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 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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Administrative Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Developmental Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Developmental Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Developmental Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Developmental Core)

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 (Developmental Core)

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 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 with justification.

Applicants may include travel funds to support early career faculty to attend a scientific meeting to present the results from their CFAR Developmental Project award. CFAR funds cannot be used to provide travel scholarships for investigators with a CFAR developmental award.

Applicants should budget funds to support developmental projects that stimulate interest in HIV/AIDS research. These funds may be used by early career investigators in the HIV/AIDS field with novel, high risk project ideas and investigators not in the HIV/AIDS research field to encourage them to explore novel approaches to HIV/AIDS research questions. Applicants may use these funds to support advising 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.

PHS 398 Research Plan (Developmental Core)

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 CFAR as a whole, and how the responsibilities of this Core advance the mission and purpose of the 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 the developmental projects 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.
• Describe the plans to support early career investigators in HIV/AIDS research, and the activities undertaken by the Core, including with working with other CFAR Cores and SWGs, to enhance their ability to secure independent funding for their research.
• Describe plans for advising early career investigators, including investigators who are not successful in obtaining developmental project funding.
• 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 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). Note that although clinical trials studies are not allowed as a developmental core project, the Developmental Core must inform the NIH of clinical research studies funded by the CFAR that are above minimal risk, behavioral interventions or involve vulnerable populations for medical officer review and approval.
• Describe the Policies and Procedures for the proposed Developmental Core, including for example, how decisions are made, frequency of internal progress reporting, and how the overall Core progress will be assessed, including the strategic planning process, and process for reallocating funds within the Core as needed.
• 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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Developmental Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Basic Science Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Basic Science Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Basic Science Core)

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

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

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

Other Attachments: Core Utilization Table. Please title this attachment Basic Science Core Utilization Table. Applications should include a table containing information on potential Basic Science Core users and percent use by each. This table should contain information on the 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.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Basic Science Core)

• 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 (Basic Science Core)

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 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 CFAR may support technical staff to provide 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.

PHS 398 Research Plan (Basic Science Core)

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 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 CFAR as a whole, and how the responsibilities of this Core advance the mission and purpose of the 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 including, such as 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.
• 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 the Core services.
• Cite NIH-specific programs supported by the Core, and be specific about how each Core will provide support.
• Describe the plans of the Basic Science Core to foster synergy with other 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 procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet research needs.
• Describe detailed plans for a recharge system, wherein costs associated with this service Core are recovered using a proposed fee to the end user, and demonstrate how recovered costs will be allocated to additional CFAR activities, if applicable.
• Describe how the Core will measure progress and evaluate outcomes.
• Describe how cores with partial CFAR funding (e.g., leveraging existing Cores funded by NIH) will be used to enhance the research of CFAR investigators.
• 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 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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Basic Science Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Clinical Science Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Clinical Science Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Science Core)

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

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

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

Other Attachments: Core Utilization Table. Please title this attachment Clinical Science Core Utilization Table. Applications should include a table containing information on potential Clinical Science Core users and percent use by each. This table should contain information on the 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.

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Clinical Science Core)

• 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 (Clinical Science Core)

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 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 CFAR may support technical staff to provide 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.

PHS 398 Research Plan (Clinical Science Core)

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 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 CFAR as a whole, and how the responsibilities of the Core will advance the mission and purpose of the 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 such as 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.
• Demonstrate the Core’s ability to support the research base which can include NIH funded projects that may be supported by the Core.
• Describe institutional support for the Clinical Science Core including allocation of space, salary support, equipment, and etc.
• Indicate how early career investigators in the HIV/AIDS research area or faculty new to the HIV/AIDS research area will benefit from the Core services, including guidance or training in the development of protocols and regulatory documents for clinical research projects. Describe how the Clinical Science Core will provide assistance to early career investigators.
• Cite NIH-specific programs supported by the Core, and be specific about how each Core will provide support.
• Describe the plans of the Clinical Science Core to foster synergy with other 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 procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet research needs.
• Describe detailed plans for a recharge system, wherein costs associated with this Core are recovered using a proposed fee to the end user, and demonstrate how recovered costs will be allocated to additional CFAR activities, if applicable.
• Describe how the Core will measure progress and evaluate outcomes.
• Describe how cores with partial CFAR funding (e.g., leveraging existing Cores funded by NIH) will be used to enhance the research of CFAR investigators.
• 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 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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Clinical Science Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Additional Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Additional Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Additional Core)

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

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

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

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

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

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Additional Core)

• 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 (Additional Core)

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

The Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of 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 CFAR may support technical staff to provide 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.

PHS 398 Research Plan (Additional Core)

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 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 CFAR as a whole, and how responsibilities of this Core advance the mission and purpose of the 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 such as 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.
• Demonstrate the Core’s ability to support the research base which can include NIH funded projects that may be supported by the Core.
• Describe institutional support for the Core including allocation of space, salary support, equipment, etc.
• Indicate how early career investigators in the HIV/AIDS research area or faculty new to the HIV/AIDS research area will benefit from the Core services.
• Cite NIH-specific programs supported by the Core, and be specific about how each Core will provide support.
• Describe the plans of the Core to foster synergy with other 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 procedures for obtaining assessments from HIV/AIDS investigators about the Core’s ability to meet research needs.
• Describe detailed plans for a recharge system, wherein costs associated with this Core are recovered using a proposed fee to the end user, and demonstrate how recovered costs will be allocated to additional CFAR activities if applicable.
• Describe how the Core will measure progress and evaluate outcomes.
• Describe how cores with partial CFAR funding (e.g., leveraging existing Cores funded by NIH) will be used to enhance the research of CFAR investigators.
• Describe how the Additional 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 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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Additional Core)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type SWG.

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

SF424 (R&R) Cover (Scientific Working Group)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Scientific Working Group)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Working Group)

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 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.

Project /Performance Site Location(s) (Scientific Working Group)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Scientific Working Group)

• 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 (Scientific Working Group)

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 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.

PHS 398 Research Plan (Scientific Working Group)

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 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 CFAR as a whole, and how the SWG will advance the mission, purpose and structure of the CFAR. Explain the rationale for selection of the specific area of scientific focus and the approaches proposed to accomplish the specific aims.

• Describe the overall purpose of the SWG, 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 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 the process used by the SWG for prioritizing the activities of the SWG.
• Describe how progress towards the specific aims will be measured.
• 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.
• Describe the process for initiation and termination of the SWG, any membership requirements, and how the selected members will contribute significantly to the success of the SWG.
• 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:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Scientific Working Group)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 CFAR (Overall component). 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) (if applicable), 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 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 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 CFAR that by its nature is not innovative may be essential to advance a field.

Does the CFAR address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the 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?

Do the CFAR structure and organization enhance proposed scientific communication, outreach, synergy, and training efforts? Does the applicant institution(s) have the necessary scientific base of HIV/AIDS investigators to warrant a CFAR? Does the proposed CFAR application provide plans to 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 CFAR serve as the primary coordinating unit for the institution(s)? Is there a high likelihood of success for the proposed CFAR?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the 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?

Does the proposed plan for 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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CFAR ? 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 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 children, justified in terms of the scientific goals and research strategy proposed?

Has the applicant provided a comprehensive strategy to support the NIH-funded researchers at the CFAR institution(s)? How robust is the plan to extend CFAR support to non-CFAR and investigators new to the HIV/AIDS field at the CFAR institution(s)?

Has the applicant described the management and oversight of the 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?

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?

Is the institutional support for the proposed CFAR appropriate? Has the applicant described methods to leverage and capitalize on existing institutional resources in support of the aims of the CFAR?

Scoring: 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 CFAR.

Review Criteria for All Cores and the Scientific Working Group(s)

Are the Core/SWG services specifically 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 children, justified in terms of the scientific goals and research strategy proposed?

Are the Cores/SWGs staffed appropriately to address the workload? Do the Core/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? Are the institutional support, 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?

Supplementary criteria specific to the 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 a plan to prioritize, allocate and manage fiscal resources adequate? Has the applicant provided sufficient detail regarding how Core/SWGs will be evaluated and the remediation strategy if progress is poor?

Supplementary criteria specific to the Developmental Core

Is the plan to solicit, review, award, administer and evaluate developmental projects adequate? Has the applicant provided a plan for engaging early career and non-HIV/AIDS investigators in the 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?

Supplementary criteria specific to the Basic Science, Clinical Science, and Additional Core(s)

Are the management and oversight of the Core(s) adequate to ensure support of the NIH-funded HIV/AIDS researchers at the 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?

Supplementary criteria specific to the Scientific Working Group(s)

Is the scientific area proposed by the SWG high priority and significant at the CFAR institution? 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 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 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 six 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 six 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 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 children 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.

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the 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 National Institute of Allergy and Infectious Diseases (NIAID) 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:

• 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.

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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/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 progress report, 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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Peter Gilbert, ScM
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]

Robin Conwit, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]

Ann Namkung Lee, M.P.H.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3099
Email: [email protected]

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-496-3204
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 Kennedy National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6871
Email: [email protected]

Gallya Gannot, Ph.D., D.M.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-5096
Email: gallya.gannot@nih,gov

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

Jag Khalsa, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2159
Email: [email protected]

Michael Sakalian, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0828
Email: [email protected]

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

Rick Berzon, Dr.P.H., PA
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: 301-496-1653
Email: [email protected]

Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5049
Email: [email protected]

Roberta Dunlap 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]

Erin Davis
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-402-3839
Email: [email protected]

Robin Laney
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: [email protected]

Bryan Clark
Eunice Kennedy Shriver Kennedy 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]

Karin Mastrangelo
National Institute of Diabetes and Digestive Kidney Diseases (NIDDK)
Telephone: 301-443-3603
Email: [email protected]

Pamela G. Fleming
National Institute of Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: [email protected]

E. C. Melvin
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3912
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]

Kasima Garst, MFS
Fogarty International Center (FIC)
Telephone: 301-496-5710
Email: [email protected]

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