Part 1. Overview Information

Key Dates

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

HIV-related comorbidities, coinfections, and complications (CCCs) cause significant pathology and suffering in people with HIV (PWH). These conditions include cardiovascular disease, lung disease, HIV-related cancers,, hepatobiliary disease, metabolic perturbations, obesity, enteritis, and renal disease. Some infections are more common in people with HIV than in the general population, including tuberculosis (TB), hepatitis B and C, human papillomavirus (HPV), and other sexually transmitted infections.

While these HIV CCCs also occur in people without HIV, there are important and unique biological mechanisms underlying their development in the context of HIV. Viral particles and antiretroviral therapy, for example, often interact with physiological and metabolic processes. For example, research has found that TB interacts with HIV and complicates the treatment outcomes for both diseases. Additionally, long-term treatment with ART may itself have consequences, interactions with other medications, HIV drug resistance, and other complications affecting health outcomes and quality of life for PWH. Therefore, the development of preventive or therapeutic strategies for HIV CCCs is dependent upon elucidating unique HIV-specific pathways and mechanisms.While great strides have been accomplished to begin understanding and identify targets for interventions aimed at mitigating HIV-associated CCCs, the maintenance of a pipeline of innovative researchers with the potential to lead transformative research on CCCs in the context of HIV and/or its treatment is essential for continued progress in this area. Therefore, this FOA seeks to support highly impactful, potentially transformative research on HIV-associated CCCs led by such creative early stage investigators (ESIs).

This Catalyst Award is intended to support the development of innovative, often risky, approaches to address significant problems in HIV CCCs research in areas of interest to one or more of the participating NIH Institutes. This FOA is not intended to expand the PD/PIs current research program, but instead projects should be a new direction that is reflected by new insight or understanding. Catalyzing advances may emanate from the application of innovative approaches and/or from testing creative hypotheses.

Catalyst awardees are required to commit a substantial portion of their research effort (at least 4 person-months) to activities supported by the award. Effort expended toward teaching, administrative, or clinical duties should not be included in this calculation. For example, 33% effort in a 12-month calendar appointment would equal approximately 4.0 person-months (12 x 0.33 = 4.0). For Additional details regarding how effort may be calculated in person-months, please refer to information posted on the NIH Office of Extramural Research website (here). Investigators who will not be able to meet this requirement should not submit applications.

Scope

Applications appropriate to this FOA should be consistent with the scientific priorities outlined by the NIH Office of AIDS Research (OAR), which were most recently described in NOT-OD-20-018. The award is intended to support innovative, high-impact,research by early stage investigators that will open new areas of HIV/AIDS research related to CCCs within the mission of one or more of the NIH components participating in this FOA. Areas of interest include novel mechanistic research into pathogenic processes, identification of novel preventive or therapeutic targets,interventions, or therapies; novel approaches to delineate unique biological pathways for HIV-associated CCCs in PWH as compared to those CCCs in people without HIV; pathogenesis of multimorbid HIV-associated CCCs; and/or identification of unique potential drug targets in PWH.

Interests of Specific Institutes/Centers

The scientific interests of participating Institutes and Centers (ICs) are summarized below. Applicants are encouraged to contact the Scientific/Research contact of the intended IC to ensure that the aims of the proposed project are consistent with IC mission and OAR's scientific priorities.

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

NIDDK encourages innovative projects aimed at elucidating the unique biological mechanisms leading to HIV-associated CCCs within its mission. NIH defines a mechanistic study as a study "designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. Submitted proposals are expected to integrate HIV basic science and pathobiology, pathophysiology, and/or metabolism. These include gastrointestinal immune and microbial homeostasis, enteropathy, noncommunicable liver and biliary diseases, viral hepatitis, and obesity; metabolic/endocrine dysfunction and perturbations; kidney disease, benign genitourinary diseases and disorders, and hematologic sequelae. Moreover, NIDDK-relevant pathogenic processes may contribute to HIV pathogenesis in other tissues and organ systems. For example, loss of intestinal epithelial barrier function in HIV-associated enteropathy may result in systemic inflammation that contributes to comorbidities such as obesity or liver disease. Mechanistic interrogation of the processes whereby HIV or its treatment contributes to these CCCs is also encouraged. NIDDK Encourages Research on Sex/Gender Differences, Sexual and Gender Minority-Related Research and Race/Ethnic Diversity as defined in NOT-DK-22-003 Projects addressing how these biologic and social constructs impact physiologic or metabolic pathogenic mechanisms related to NIDDK-relevant HIV CCCs are therefore welcome. This FOA aligns with the Mission and Vision of the NIDDK Strategic Plan for Research, including the theme of empowering a multidisciplinary workforce, engaging a broad range of stakeholders, and pursuing pathways for the health of all. Specifically, this FOA aligns with the Scientific goals (e.g. 1.1 and 1.2) of the Strategic Plan.

NIDDK expects projects to undertake a "wet bench" approach and will not support projects with a primarily epidemiological focus. NIDDK will support mechanistic projects that include basic experimental studies involving humans (BESH), which are studies that meet both the definition of basic research and the NIH definition of a clinical trial. Clinical trials seeking to establish safety, assess clinical efficacy or effectiveness, and/or study/manage/implement, preventive, therapeutic, or services interventions will not be supported.

National Cancer Institute (NCI)

NCI encourages research that advances our understanding of the risks, development, progression, diagnosis, and treatment of malignancies observed in individuals with an underlying HIV infection. Specifically in areas such as etiologic factors, coinfections, cofactors, immunopathogenesis, diagnosis, and consequences of both non-AIDS defining and AIDS-defining malignancies in populations with an underlying HIV infection.

Cancer focused applications proposing a clinical trial can only propose mechanistic clinical studies that meet NIH's definition of a clinical trial (NIH's Definition of a Clinical Trial). These studies must be designed to understand a biological or behavioral process, the pathophysiology of disease, and/or the mechanism of action of an intervention (examples of mechanistic clinical trials can be found in NOT-OD-18-010).Clinical trials seeking to establish safety, assess clinical efficacy or effectiveness, and/or study/manage/implement, preventive, therapeutic, or services interventions will not be supported.

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

NICHD supports biomedical research to understand the effects of infection with HIV among populations central to the NICHD mission, including pregnant, postpartum, and lactating women, infants, children, adolescents and young adults, people with intellectual and developmental disabilities, and individuals with physical disabilities or mobility impairments. Studies are expected to align with the HIV/AIDS research priorities outlined by the NIH Office of AIDS Research (OAR) in NOT-OD-20-018 UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding.

National Heart, Lung and Blood Institute (NHLBI)

NHLBI intends to support ESIs performing multi-disciplinary and mechanistic research aimed at deciphering the complexity of HIV-associated CCCs related to HLBS priorities, including interactions between HIV infection, aging, the effect of existing risk factors and the impact of multiple medication use. High-priority topics will include (but are not limited to) immune activation and chronic inflammation, effects of the microbiome and virome on HIV-associated CCCs, as well as aging and immune-senescence. Examples of projects that are of interest to the NHLBI and responsive to this FOA include (but are not limited to) those that propose to:

• Identify the common drivers of inflammation/chronic immune activation, initiation, and progression of heart, lung, blood, and sleep (HLBS) disorders in the setting of treated HIV infection;
• Studies aiming to understand molecular mechanisms underlying multilevel effects of biological sex on HIV-associated CCCs related to HLBS diseases;
• Characterize the common inflammatory mechanisms linked to multiple heart, lung, blood, sleep (HLBS)-related end-organ diseases;
• Determine the effects of antiretroviral therapy (ART) on lipid biogenesis/homeostasis and identify the effect on inflammatory profiles
• Explore how ongoing, low-level HIV replication in the setting of ART contributes to immune dysfunction
• Determine how the microbiome and virome interact with the host (and vice versa) to affect metabolism and immune response, potentially contributing to HLBS comorbid disease development;
• Explore how long-term ART use affects HLBS-related organ systems;
• Determine how HIV-induced immunosenescence, in combination with normal inflammaging, contributes to HLBS comorbid disease development;
• Identify potential targets for therapeutics development aimed at reducing immune activation/inflammation in the context of HLBS diseases;
• Explore how therapies that impact inflammation/immune activation can reduce the risk of HLBS comorbidities and/or impact HIV cure;
• HLBS priorities

NHLBI expects projects to undertake a "wet bench" approach and will not support projects with a primarily epidemiological focus. In addition, NHLBI will not support clinical trials with this initiative.

Applications Not Responsive to this FOA

Applications not responsive to this FOA will be withdrawn and not be reviewed. Nonresponsive applications include:

• Projects led by a PD/PI who is not ESI eligible.
• Projects with a Multiple PD/PI structure.
• Projects that primarily address diseases, processes, or topics outside of the interests described by the above ICs.
• Projects that have one or more components that pursue CCCs outside of the context of HIV/AIDS and therefore are ineligible for the use of HIV/AIDS-designated funds. The guidelines for allocation of HIV funding have been described most recently described in NOT-20-018, UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

NOTE: Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted. The PD/PI) is the only individual who can be listed on the SF424 form.

Frequently Asked Questions about the NIH Early Stage Investigator (ESI) Policy can be found at https://grants.nih.gov/policy/early-investigators/index.htm/.

An extension to the 10-year period may be granted under special circumstances (e.g., childbirth, family care responsibilities, extended periods of clinical training, disability or illness, etc.). See NOT-OD-19-125 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-125.html) for instructions on applying for an ESI extension.

Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion. Applicants should allow several weeks for an extension request to be processed. NOTE: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed.

Applicants also must hold an independent research position at a domestic (U.S.) institution as of September 1 of the fiscal year of the application's advisory council review (Federal Fiscal Year starts October 1 and ends September 30). For the purpose of this FOA, independent research position means a position that automatically confers eligibility, by the applicant’s institutional policy, for an investigator to apply for R01 grants, with an appropriate commitment of facilities to be used for the conduct of the proposed research. Investigators still in training or mentored status (postdoctoral fellows) may apply if, by the receipt date, they have a written commitment of an independent faculty position as of September 1 of the fiscal year of the application's advisory council review

Applicants may submit or have an R01 (or other equivalent) grant application pending concurrently with their Catalyst Award application provided that each application is scientifically distinct. If the applicant receives an R01 before the Catalyst can be awarded, then the investigator is no longer eligible for a Catalyst award. Please see section 3, below, for more information about limitations on overlapping applications.

Awardees are required to commit at least 4 person-months out of a 12 month calendar year each year to activities supported by the Catalyst Award.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. 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.

Letter of Intent

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

Page Limitations

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

Instructions for Application Submission

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

Agency Routing Identifier Field: DO NOT USE.

Type of Application: Must be "New or Resubmission." Resubmission applications are allowed only from this FOA.

Proposed Project: Start date: For FY2024 enter 04/01/2024; For FY2025 enter 12/01/2024; For FY2026 enter 12/01/2025. :

Total Federal Funds Requested: Enter $1,750,000 (See note below.)

Total Non-Federal Funds: Enter $0.

Total Federal & Non-Federal Funds: Enter $1,750,000

Estimated Program Income: Enter $0.

Note: The Budget Request is entered only in Fields "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total - $1,750,000 -- should be entered in Fields "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds." Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed, with the following modifications:

Project Summary/Abstract: Attach an abstract describing the goals of the project: Text only no figures, animations, or web links are allowed.

Project Narrative: In 2-3 sentences written in plain language describe how the proposed research advances HIV-associated comorbidities, coinfections, and complications research..

Bibliography & References cited: DO NOT USE. Reference citations are not required, but may be included in the essay and will be included in the page limit.

Facilities & Other Resources Statement: 1 page maximum.

Equipment: DO NOT USE.

Other Attachments: DO NOT USE

SF424(R&R) Senior/Key Person Profile

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

Profile - Project Director/Principal Investigator Field: Attach Current and Pending Support: Attach a list of Current and Pending Support from all sources, including current year direct costs and person-months devoted to each project.

Profile - Senior Key Person 1: Do not use. Submit information only for PD/PI. Information on collaborators or other key personnel is not required but may be included in the Essay.

Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profile(s): Do not use. Only the PD/PI may serve as senior/key personnel.

Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): Do not use. Only the PD/PI may submit a Biographical Sketch

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

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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

Specific Aims: Do not use

Research Strategy: Upload the Essay here (Six pages total)

Describe your innovative vision for addressing a major problem related to HIV comorbidities, coinfections, and complications within the mission of one or more of the participating components. Explain the importance of this problem or challenge, and your qualifications to lead this project. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. The essay should include the following sections in the order given with the headings as shown below:

Project description: What is the scientific problem or challenge that will be addressed, and why is this important? What is the premise of the project, including strengths and weaknesses of prevailing relevant theories? What are the pioneering, and possibly high-risk, approaches that, if successful, might lead to highly impactful results? How will you ensure that the results will be robust and unbiased? The writing should be at a level that conveys the significance and impact of the application to broadly knowledgeable scientists with different expertise domains.

Evidence of PD/PI innovativeness: What concrete evidence can you provide for your claim of innovativeness? For example, qualities common to many highly innovative people include an interest in, and the ability to integrate, multiple types and sources of information; an inclination to challenge paradigms and take intellectual risks; persistence in the face of failure; an ability to attract the right collaborators; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.

How the planned research differs from the PD/PI's past or current work: How does the proposed project represent a new and distinct direction for your research? While a new research direction may have as its foundation the applicant's prior work and expertise, it cannot be an obvious extension or scale-up of a current research enterprise. Rather, a new research direction must reflect a fundamental new insight into the potential solution of a problem, which may derive from the development of exceptionally innovative approaches and/or from the posing of unconventional hypotheses. Applications for projects that are extensions of ongoing research should not be submitted. If the proposed project represents an entirely new direction or shift into a new scientific field, explain how you will incorporate any field-specific expertise such as collaborators, consultants, institutional core resources or other approaches, to assist in addressing the problem or challenge.

Suitability for the Catalyst Award program: Why is the planned research uniquely suited to stated goals of this Catalyst Award program, rather than a more traditional grant mechanism?

Statement of research effort commitment: A statement should be included that, if chosen to receive an award, the PD/PI will commit a minimum of 4 person-months of his/her research effort to the project supported by the Catalyst Award. Applicants with current research commitments exceeding 8 person-months should provide a compelling explanation describing how their effort on existing grants will be adjusted to permit them to devote the required minimum effort to the Catalyst Award project.

Note: References are not required but if included must fit within the six-page limit. Figures and illustrations may be included but must also fit within the six-page limit. Information on collaborators may be included in the Essay and their names and affiliations should be listed in the Cover Letter.

Progress Report Publication List: Do not use.

Multiple PD/PI Leadership Plan: Do not use.

Consortium/Contractual Arrangements: Describe any planned consortium or contractual arrangements that will be needed to accomplish goals of the Catalyst award.

Letters of Support: Provide any letters of support from collaborators or consultants needed to address the goals of this application.

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.

The following modifications also apply:

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

Appendix:

Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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). 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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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

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) 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. See Section III of this FOA for information on registration requirements.

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 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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICsencourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (https://www.nlm.nih.gov/cde/index.html) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

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

For this particular announcement, note the following:

Applications for this Catalyst Award (DP1) are meant to support individual ESI scientists of exceptional creativity who propose pioneering, highly innovative approaches that, if successful, will have a major impact on HIV comorbidities, coinfections, and complications research related to the mission of one or more of the participating NIH ICs. Catalyst Award applications do not require preliminary data, scientific aims, or a detailed research plan. Accordingly, reviewers will emphasize the following:

1) The significance and innovation of the proposed project;

2) The investigator's evidence for being innovative and the ability to commit effort that is sufficient for the proposed project.

3) Evidence that the proposed research is of sufficient risk/potential impact that is more suitable for the Catalyst Award program than for a traditional grant mechanism, and that the proposed research represents a new research direction for the PD/PI. A new research direction is considered to be one that is a not logical extension or scale-up of ongoing efforts, but rather one that is motivated by a fundamental new insight that prompts a new line of research or a substantial departure from an existing line of research.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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 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:

• 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.

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
  
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 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.

Not Applicable

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

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

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

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

Denise Russo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-435-6871
E-mail: [email protected]

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

Emmanuel Franck Mongodin
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0222
E-mail: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]

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

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]

Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-827-8014
E-mail: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.