National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Office of AIDS Research (OAR)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
Fogarty International Center (FIC)
National Cancer Institute (NCI)
P30 Center Core Grants
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
The purpose of this notice of funding opportunity (NOFO) is to invite applications for the Centers for AIDS Research (CFAR) and Developmental Centers for AIDS Research (D-CFAR) programs to provide administrative and shared research support to enhance HIV/AIDS research. CFARs provide infrastructure, expertise, resources, and services not readily obtained through other funding mechanisms. The program emphasizes interdisciplinary collaboration across all areas of HIV/AIDS research.
To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials. To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| May 25, 2027 * | May 25, 2027 * | Not Applicable | November 2027 | January 2028 | March 2028 |
| May 25, 2028 * | May 25, 2028 * | Not Applicable | November 2028 | January 2029 | March 2029 |
| May 25, 2029 * | May 25, 2029 * | Not Applicable | November 2029 | January 2030 | March 2030 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
The Centers for AIDS Research (CFAR) program, inclusive of the Developmental CFAR (D-CFAR), are designed to enhance synergy and coordination among independent research laboratories by sharing resources, supporting emerging research opportunities, and promoting efficiencies. They will continue and expand support for implementation science research, including efforts related to the Ending the HIV Epidemic (EHE) in the United States (U.S.) Initiative. These Centers aim to add value to NIH HIV/AIDS research at applicant institutions by supporting collaborative activities that cannot be easily funded through standard research awards, and by fostering research aligned with NIH Unified Funding Strategy.
The CFAR and D-CFAR programs accomplish their mission by:
Advancing HIV research and its application by supporting basic, translational, and implementation science that drive the translation of scientific discoveries into effective HIV/AIDS treatment, prevention, and HIV cure strategies
While CFARs and D-CFARs serve similar missions, a D-CFAR is designed to support recipients by identifying gaps and opportunities for improvement to enhance future competitiveness for a standard CFAR. It facilitates the development of collaborations, the decision making of Core facilities essential for HIV/AIDS research and the strengthening of areas that may hinder a successful standard CFAR application. D-CFARs cannot be renewed but can compete for a standard CFAR award. A D-CFAR award is not a prerequisite to applying for a standard CFAR.
It is highly recommended, but not required, that applicants confer with the Scientific/Research Contact to discuss planned strategies for developing a CFAR or D-CFAR application to ensure alignment with NIH scientific priorities and available resources.
Hereafter, in this notice of funding opportunity (NOFO), "CFAR" applies to both CFAR and D-CFAR applications with additional details for D-CFAR noted where applicable.
The overall structure of the CFAR is designed to support the HIV/AIDS researchers at the applicant institution(s) in the conduct of their research projects, interact with a variety of organizations to promote collaborations that serve the applicant institution, and create linkages for promoting additional HIV/AIDS research in key areas identified by the scientific community.
Administrative Core - Responsible for managing, coordinating, and overseeing all CFAR activities, monitoring progress, and ensuring that the project goals are met. This Core coordinates the collaborative efforts and interaction among the Cores, Scientific Working Groups, and collaborating partners.
Advisory Committees (optional) – Committees provide guidance and feedback that are coordinated by the Administrative Core which can include:
Developmental Core - Provides short-term funding (e.g., 1-2 years) for HIV/AIDS-specific research awards and mentoring for early career investigators and investigators new to the HIV/AIDS research field.
Advanced Technology Core(s) - Provides specialized equipment, state-of-the-art emerging technologies, training, unique services, quality control, and expertise and/or advice for research activities that are not otherwise accessible for HIV/AIDS research through existing resources at the institution(s).
Clinical Science Core(s) - Provides resources for HIV/AIDS translational research among collaborating clinical, social and behavioral, and basic scientists.
Activities that will not be supported by a CFAR Clinical Science Core include normal patient care, such as screening of clinical specimens, diagnosis, treatment, and rehabilitation.
Implementation Science (IS) Core(s) - Provides resources to enable institutions to make significant contributions to the field of implementation science, for example, activities to support the EHE Initiative. The Core should serve a growing need for IS expertise, consulting services, and capacity building in the wider HIV research field. The Core supports interdisciplinary collaborations and research that studies strategies to adopt, disseminate, and integrate evidence-based health interventions into practice to improve and sustain individual and population health in HIV treatment, prevention, and cure.
Additional Core(s) (Optional)
Additional Cores may be proposed if they are needed to advance the local HIV/AIDS research efforts. Some examples of additional cores could also include Social/Behavioral, Biostatistics, Data Science, Artificial Intelligence (AI), Prevention, HIV Cure, or Bioinformatics. Additional Cores may be of a nature other than advanced technology or clinical.
A Scientific Working Group (SWG) is defined as a group of investigators (HIV and non-HIV) who share a common interest in a specific area of scientific focus that is critical to addressing the HIV epidemic but is a gap or underdeveloped at the CFAR institution(s).
Applications proposing the following topics will be considered non-responsive and will not be reviewed:
See Section VIII. Other Information for award authorities and regulations.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project and are dependent on the applicant institutions' NIH HIV/AIDS-funded research base (FRB) and whether the application is for a CFAR or a D-CFAR. See Section III.3 for additional information on eligibility.
The scope of the proposed project should determine the project period. The maximum project period is five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. Obtaining an eRA Commons account can take up to 2 weeks.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
Only one application per institution (normally identified by having a unique entity identifier (UEI) number or NIH IPF number) is allowed.
Applicant organizations must choose to submit either a D-CFAR application or standard CFAR application. A D-CFAR award is not a prerequisite to apply for a standard CFAR.
The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
One CFAR Award per Institution
No institution may submit or participate as a performance site for more than one CFAR or D-CFAR award concurrently. An institution that is part of a multi-institutional CFAR or D-CFAR application or award may not be listed as a multi-institutional participant in another CFAR application or apply as a single institutional CFAR or D-CFAR. Independent campuses that are part of a large multiple city university are considered to be separate institutions (normally identified by having a unique entity identifier (UEI) or NIH IPF number), and each may submit one application.
Multi-institutional CFAR
Two or more institutions may submit an application for a single CFAR or D-CFAR award. The institutions do not need to be in the same geographical area if the applicant can demonstrate a feasible plan for collaborative research networks using CFAR or D-CFAR Cores across all institutions.
Cores Outside of the CFAR institution
With appropriate justification, CFAR or D-CFAR awards may support a Core at an institution that is not part of the CFAR or D-CFAR if it provides a unique resource.
NIH HIV/AIDS Funded Research Base (FRB)
Institutions/Organizations with a HIV/AIDS FRB of $10M annually (minimum) are eligible to apply for a CFAR. Amounts in excess of $10M will result in a larger base award. The NIH HIV/AIDS FRB is defined as the amount of Total Cost funding from NIH for one fiscal year (October 1 to September 30) preceding the calendar year of application submission. Funding amounts for Tier levels will be confirmed at the time the competing award is made. The NIH HIV/AIDS FRB is compiled from data provided by the NIH Office of AIDS Research. Applicants can request the FRB from the Scientific/Research Contact.
D-CFARs qualify for one funding level. Standard CFARs qualify for three tiers of funding based on the FRB for the institution.
Tier | HIV/AIDS Funded Research Base (FRB) | Base Request (total cost $) |
D-CFAR | >$10M | $1,000,000 |
1 | >$10M to <$40M | $1,750,000 |
2 | >$40M to <$80M | $2,500,000 |
3 | >$80M | $3,250,000 |
The FRB includes NIH peer-reviewed HIV/AIDS research grants, program projects, and cooperative agreements utilizing the following mechanisms only: DP1, DP2, DP5, PF5, R00, R01, R03, R15, R21, R24, R33, R34, R35, R36, R37, R56, R61, RF1, RM1, SC1, SC2, SC3, U01, U10, U24, U34, UF5, UH2, UH3, UG3, and K series awards. The following mechanisms or components of these mechanisms may be considered based on whether or not the award or component involves primarily research activity: KL1, KL2, N01, P01, P30, P50, P60, PM1, U19, U54, UG1, UM1, UM2 and RC series grants.
Conditions to the NIH HIV/AIDS FRB:
Multi-institutional CFAR applications may combine the NIH HIV/AIDS FRBs to meet the eligibility criteria for this funding announcement. CFARs that include a distant institution for a core component may not use the FRB of that institution if they are not including all of the NIH HIV/AIDS investigators at that institution as part of the CFAR.
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
| Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
|---|---|---|---|---|---|
| Overall | Overall | 30 | Required | 1 | 1 |
| Administrative Core | Admin Core | 12 | Required | 1 | 1 |
| Developmental Core | Developmental Core | 12 | Required | 1 | 1 |
| Advanced Technology Core(s) | Advanced Tech Core | 12 | Required | 1 | NA |
| Clinical Science Core(s) | Clinical Sci Core | 12 | Required | 1 | NA |
| Implementation Science Core(s) | IS Core | 12 | Required | 1 | NA |
| Additional Core(s) | Additional Core | 12 | Optional | 0 | NA |
| Scientific Working Group(s) | SWG | 6 | Required | 1 | 3 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
The application should consist of the following components:
When preparing the application, use Component Type 'Overall'.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions, with the following additional instructions:
Project Summary/Abstract: Applicants should clearly indicate in the abstract if the application is for a CFAR or D-CFAR award.
Facilities and Other Resources: Applicants should clearly demonstrate their institution's commitment to the proposed CFAR. For proposed CFARs with multiple Cores and investigators in different locations, provide a plan for communication among the various locations, plans for transportation of specimens, data and results among major locations, especially those located outside of the United States.
Other Attachments: Applicants must provide the following additional material specified below. Each attachment should be uploaded as a separate PDF using the indicated filename.
NIH HIV/AIDS FRB and non-FRB investigators at the institution(s): This attachment must be titled "FRB and non-FRB HIV/AIDS Investigators". For this attachment, applicants must request this from the Scientific/Research Contact. Describe how investigators plan on participating in the CFAR. Include a justification for why any investigators listed on the FRB are not participating as CFAR members. Following the FRB provided spreadsheet, applicants must also indicate the names of investigators at their institution(s) who will become part of the CFAR but who were not included in the FRB spreadsheet to show other NIH and non-NIH funded HIV/AIDS investigators who will participate in the CFAR.
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 NOFO) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
New applications must use the base total cost amount award for the Tier level in which the applicant is eligible as noted in Section III. Renewal applications may request budget increases above their qualified Tier level. Applicants should follow the NIAID Financial Management Plan when developing budgets for the CFAR for the competing year and out years.
Applicants must consult with Program to request increases over the Tier level for any or all years prior to application submission.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims: Describe the specific aims of the overall CFAR or D-CFAR, as appropriate, and outline how the different Cores will contribute to these aims.
Instructions in this notice of funding opportunity (NOFO) hereafter that mention "CFAR" apply to both CFAR and D-CFAR applications. Specific instructions for D-CFARs are noted where applicable.
Research Strategy: Describe the proposed Overall Research Strategy and the strategic planning process of the CFAR, and how the CFAR will contribute to meeting the overarching goals and objectives, and/or the potential for unique contributions to the overall HIV/AIDS research at the applicant institution(s). Specifically, define the impact that a CFAR could have to increase the percentage of NIH-funded HIV investigators, enhance HIV/AIDS research at the applicant institution(s), and exert a sustained influence on the HIV/AIDS research field.
Letters of Support: Provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining:
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Admin Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Administrative Core)
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
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.
Budget forms appropriate for the specific component will be included in the application package.
The Administrative Core budget may include equipment, supplies, support contracts, and other necessary expenses. Budget costs for administrative support must relate directly to the CFAR proposed work. All items should be fully justified for allocation of CFAR funds within the Budget Justification.
Other administrative costs may include those necessary for the central administration and fiscal management of the CFAR, including relevant and reasonable costs for reprints, graphics, and publications for Developmental Core users.
Include travel funds for the CFAR PD(s)/PI(s) and Administrative Core Lead to attend the Annual CFAR Meeting. Include other travel funds for CFAR specific meetings and NIH requested meetings. Travel funds for leadership of Core(s)/SWG(s) may only be included if the purpose is to attend meetings that provide new information or approaches used within the Cores.
The Administrative Core must include funding to plan and host one CFAR Annual Meeting during the project period, recommended to be included in budget years 2 or 3 (not applicable for new CFARs or D-CFARs).
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims:
Describe the specific aims of the Administrative Core, and how the Core will coordinate and manage activities across the CFAR or D-CFAR, as appropriate, and have an impact on the research infrastructure.
Research Strategy:
Describe the role of the Administrative Core in the CFAR as a whole and how the responsibilities of the Core advance the mission and purpose of the CFAR.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Developmental Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Other Attachments: Applicants must include a table titled "Previous (or proposed) Recipients of Developmental Awards Table". Renewal applications should describe the outcomes of previously funded developmental projects. The time period should include all years for which the CFAR was funded but not to exceed the most recent ten years. This table should contain information on the CFAR Investigators, the type of investigator, study title, year funded, the total amount of funding, resulting collaborations, resulting awards, and any resulting publications. New applicants should describe potential early career investigators eligible for developmental projects.
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.
Budget forms appropriate for the specific component will be included in the application package.
As applicable, include funds for equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds.
Applicants may request support for early career investigator salary for scientific developmental projects.
As applicable, include funds to mentor and support developmental awards for early career investigators to advance HIV/AIDS research and research towards independent funding. Funds may also be used for investigators not in the HIV/AIDS research field to encourage them to explore novel approaches to HIV/AIDS research questions. Applicants may use funds to support programs and mentoring for students and investigators of various career stages.
Travel funds to support early career faculty to attend a scientific meeting are only allowed to present results from their CFAR Developmental Project award.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims:
Describe the specific aims of the 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 along with the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
PHS Human Subjects and Clinical Trials Information (Developmental Core)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Advanced Tech Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Other Attachments: Each application must submit a Core Utilization Table for each proposed Core. This attachment must be titled "Advanced Technology Core Utilization Table." Applications should include a table containing information on potential or current 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, type of support provided, and the percent use.
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.
Budget forms appropriate for the specific component will be included in the application package.
As applicable, include funds for equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds. The CFAR may support technical staff to provide CFAR services in Core facilities.
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 and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims:
Describe the specific aims of the 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, innovate, 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 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, along with the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Clinical Sci Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Other Attachments: Each application must submit a Core Utilization Table for each proposed Core. This attachment must be titled, "Clinical Science Core Utilization Table." Applications should include a table containing information on potential or current 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, type of support provided, and the percent use.
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.
Budget forms appropriate for the specific component will be included in the application package.
As applicable, include funds for equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds. The CFAR may support technical staff to provide CFAR services in Core facilities.
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 and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims:
Describe the specific aims of the 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, innovate, 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 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, with respect to the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'IS Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Other Attachments: Each application must submit a Core Utilization Table for each proposed Core. This attachment must be titled, "Implementation Science Core Utilization Table." Applications should include a table containing information on potential or current 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, type of support provided, and the percent use.
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.
Budget forms appropriate for the specific component will be included in the application package.
As applicable, include funds for equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds within the Budget Justification. The CFAR may support technical staff to provide CFAR services in Core facilities.
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 and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims:
Describe the specific aims of the 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, innovate, 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 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 with respect to the following items:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Additional Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Other Attachments: Each application must submit a Core Utilization Table for each proposed Core. This attachment must be titled, "[Name of Core] Core Utilization Table." Applications should include a table containing information on potential or current 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, type of support provided, and the percent use.
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(s))
Budget forms appropriate for the specific component will be included in the application package.
As applicable, include funds for equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds. Any budget requested for support of the Core Lead must match the effort associated with the Core management. The CFAR may support technical staff to provide CFAR services in Core facilities.
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 and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims:
Describe the specific aims of the 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, innovate, 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 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.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'SWG.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.
Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Other Attachments: Each application must submit a Scientific Working Group Table. This attachment must be titled "Scientific Working Group Member Table." Applications should include a table containing information such as name, title, scientific area of expertise, and level of engagement for all potential Scientific Working Group members.
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.
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims:
State the specific aims of the Scientific Working Group (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 scientific focus that is important for the research agenda, but that is not already well-established at the CFAR institution(s), and the approaches proposed to accomplish the specific aims with respect to the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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 How to Apply- 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 Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project 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 project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this NOFO:
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this NOFO:
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 project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project 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, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
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 and Scientific Working Group(s) of the CFAR.
To what extent are the strategic planning, policies, procedures for evaluation and reassignment of priorities, fiscal management, and remediation strategies for underperforming Cores/SWGs clearly described and sufficient?
To what extent are plans for soliciting, awarding, and evaluating developmental pilot projects, engaging early career and investigators new to HIV, fostering multidisciplinary research, and mentoring well-conceived and effective? To what extent does the Core have an adequate and appropriate number of early career investigators and investigators new to HIV to support through developmental pilot awards? How effective is the Core in ensuring the success of developmental pilot projects and early career and investigators new to HIV?
To what extent is management and oversight, engagement of early career investigators, prioritization of Core use, feedback mechanisms from HIV/AIDS researchers, and if applicable, robustness of specimen repositories, appropriate and sufficient? How effective and adequate are the Core's plans and support for NIH HIV/AIDS funded investigators at the institution(s)?
To what extent does the SWG effectively address high-priority gaps and underdeveloped areas, advance scientific knowledge or practice, integrate novel approaches, and successfully engage new and early career investigators? To what extent does the SWG membership bring together varied scientific perspectives that are well-suited to address both current and future research needs in the proposed area?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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 (as applicable), 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 (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
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 CSR, in accordance with NIH peer review policies and practices, 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 may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
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:
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access their 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 Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Recipient-selected projects that involve studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on MAT/MOUD.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
In administering programs under this and all funding announcements, NIH prioritizes:
Not Applicable
A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
CFAR Program Contact
National Institute of Allergy and Infectious Diseases (NIAID)
Email: CFARprogram@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
National Institute of Allergy and Infectious Diseases (NIAID)
Email: niaidfinancial-grantscontact@mail.nih.gov
Office of AIDS Research (OAR)
E-mail: OARinfo@nih.gov
Fogarty International Center (FIC)
Email: FIC-Extramural@nih.gov
National Heart, Lung, and Blood Institute (NHLBI)
Email: NHLBIOGMInbox@nhlbi.nih.gov
Subject: PAR-27-063
National Institute on Aging (NIA)
Email: NIA-NOFO-Grants@nih.gov
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: nichdgrantsmanagement@mail.nih.gov
National Institute of Dental and Craniofacial Research (NIDCR)
Email: deeranotifications@nidcr.nih.gov
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Email: NIDDKGMBManagementTeam@niddk.nih.gov
National Institute of Drug Abuse (NIDA)
Email: nidagmbemail@nida.nih.gov
National Institute of Mental Health (NIMH)
Email: NIMHNOFOGrantsManagement@mail.nih.gov
National Institute of Nursing Research (NINR)
Email: NINRProgram@mail.nih.gov
National Institute on Minority Health and Health Disparities (NIMHD)
Email: NIMHD-CGMO@mail.nih.gov
Fogarty International Center (FIC)
Email: fichivprograms@mail.nih.gov
National Cancer Institute (NCI)
Email: NCIFinancialContact@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.