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 NOFO or in a Notice from NIH Guide for Grants and Contracts ).

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

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The NIDDK Catalyst Award is intended to support investigators developing bold, innovative, and often risky approaches to address significant and intractable problems in research topics of interest within two extramural divisions of NIDDK: the Division of Diabetes, Endocrinology and Metabolic Diseases and the Division of Digestive Diseases and Nutrition. To be considered pioneering or catalyzing, the proposed research must reflect approaches substantially different from the current state-of-the-art, or ideas outside the mainstream of contemporary research. The program is not intended to expand a current research program's funding in the area of the proposed project, but instead must reflect a fundamental new insight or understanding that will revolutionize the field. Catalyzing advances may emanate from the application of exceptionally innovative approaches and/or from testing radically unconventional hypotheses.

Catalyst recipients 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.

Research Scope

This NOFO will only support research within the mission of NIDDK.? Research applications in areas that are primarily within the missions of other NIH Institutes and Centers are not appropriate for this NOFO and will not be supported. NIDDK has many research areas within its mission, but all research related to relevant diseases may not be appropriate for NIDDK.? Applicants to this NOFO are strongly encouraged to contact NIDDK staff as soon as possible in the development of the application, so that NIDDK staff can help the applicant understand whether the application is within the goals and mission of the Institute and is appropriate for this NOFO.

Applications submitted to this NOFO should be directly focused on diseases or conditions that are central to the mission of either the Division of Diabetes, Endocrinology and Metabolic Diseases (DEMD), or the Division of Digestive Diseases and Nutrition (DDN) of the NIDDK. Research focused on diseases or conditions central to the mission of NIDDK's Division of Kidney, Urologic and Hematologic Diseases (here) will not be considered responsive to this initiative.

Research areas of interest for DEMD include:

• Diabetes: diabetes and other metabolic disorders, including inborn errors of metabolism and rare genetic metabolic diseases such as lipodystrophy and maturity onset diabetes of the young (MODY); non-pulmonary aspects of cystic fibrosis pathogenesis and pathophysiology; metabolic or endocrine complications related to HIV or anti-retroviral therapy; complications of diabetes that affect multiple organ systems, or the specific complications of diabetic foot ulcers, peripheral sensory neuropathy, and neurovascular or neurocognitive complications of diabetes.
• Endocrinology: development, metabolism and basic biology of the endocrine system including pathophysiology of endocrine disorders involving thyroid and parathyroid; neuroendocrinology of energy balance, including neural pathways and peptides that regulate feeding behavior, satiety, and energy expenditure.
• Metabolism: mechanisms regulating metabolism, metabolic dysfunction, and tissue crosstalk in specific peripheral tissues such as adipose, bone, muscle, or liver; effects of the intrauterine environment on metabolic responses in offspring.
  

Research areas of interest for DDN include:

• Digestive Diseases: achalasia, gastroesophageal reflux disease, peptic ulcer disease, gastrointestinal bleeding, diarrhea, malabsorption, appendicitis, inflammatory bowel diseases, celiac disease, functional GI and motility disorders, metaplasia, and dysplasia;
  
• Hepatobiliary diseases: nonalcoholic fatty liver disease, chronic hepatitis, cirrhosis, drug-induced liver injury, autoimmune liver diseases [autoimmune hepatitis, sclerosing cholangitis, primary biliary cholangitis], biliary atresia and cholestatic liver diseases of childhood, genetic liver diseases, gallbladder disease, liver transplantation; as well as investigation of molecular pathways involved in liver development, injury, inflammation, repair, cholestasis, and fibrosis;
  
• Exocrine pancreatic diseases: acute and chronic pancreatitis, autoimmune pancreatitis (idiopathic and familial), pancreatogenic diabetes;
  
• Pathophysiological mechanisms related to obesity and nutrition including nutrient metabolism and energy balance, gut-brain interactions related to food intake, integration of microbiome-nutrient host interactions, and integrated response to a meal;
  
• Mechanisms of central and peripheral neural control of the normal digestive system and the role of neural mechanisms in diseases and conditions;
  
• HIV/AIDS research in the context of the above areas of interest.

Prior to applying, investigators are strongly encouraged to contact the Scientific/Research Contacts listed in Section VII of this NOFO to discuss the appropriateness of the proposed research for this NOFO.

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

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 NOFO.

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 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 their 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.

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

NOTE: Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will be withdrawn and will not be peer reviewed.

2. Cost Sharing

This NOFO 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 NOFO. 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 notice of funding opportunity 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, address, and telephone number of the PD/PI
• Names of other key personnel
• Participating institution
• Number and title of this funding opportunity
  

The letter of intent should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofIntent@mail.nih.gov

Page Limitations

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

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

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

Agency Routing Identifier Field: DO NOT USE.

Type of Application: Must be "New".

Proposed Project: Enter start date: 7/1/2024; Enter end date: 7/1/2029

Total Federal Funds Requested: Enter $2,500,000. (See note below.)

Total Non-Federal Funds: Enter $0.

Total Federal & Non-Federal Funds: Enter $2,500,000

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 - $2,500,000 -- 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. The additional instructions apply:

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. The additional instructions apply:

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

R&R Budget

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

R&R Subaward Budget

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

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

Introduction to Application: Do not use.

Specific Aims: Do not use.

Research Strategy: Upload the Essay here (Five pages total).

Describe your innovative vision for addressing a major biomedical or behavioral problem or challenge in mission areas supported by NIDDK's Division of Diabetes, Endocrinology and Metabolic Diseases (NIDDK-DEMD), or by NIDDK's Division of Digestive Diseases and Nutrition (NIDDK-DDN). Explain the importance of this problem or challenge, and your qualifications to engage in groundbreaking research to address these challenges. 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 groundbreaking or paradigm-shifting 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, diverse 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, which could be anticipated to be appropriate for a new or renewal R01 application. 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 radically 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, 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 the NIDDK 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 five-page limit. Figures and illustrations may be included but must also fit within the five-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 NIDDK 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 additional instructions apply:

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 application forms packages.

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

• 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.
• Data Release Principles and Standards: Data from this NOFO are expected to be shared in an easily accessible, machine-readable format to increase the value of the public investment. Consistent with achieving the goals of the Catalyst program, the NIDDK expects that information such as data syntheses, study protocols, bioinformatics tools, and any other metadata collected will be widely shared with the scientific community and made publicly available through data repositories. As part of the Resource Sharing Plan, applicants should describe prior experience in successfully implementing data and resource sharing policies to meet NIH sharing goals.
• Data sharing: All data generated through this NOFO are expected to be deposited into dbGaP (http://www.ncbi.nlm.nih.gov/sites/entrez?db=gap) or other NIH Trusted Partners databases. All data without privacy concerns are expected to be deposited in appropriate public databases as approved by NIH staff. In general, rapid deposition of data into repositories will be expected to maximize utility to the scientific community. The applicant's sharing approach should reflect the expected broad and rapid data sharing as outlined in the NIH data sharing policy (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html). Additionally, applicants are expected to adhere to future changes to NIH-wide data sharing policies. Applicants should provide a specific proposal for release of data and are encouraged to address the issue of frequency of the release, based on practical considerations or previous experience and the recommendations above. Applicants should address whether they anticipate any of their data requiring controlled access. The reasonableness of the proposed data sharing plan will be assessed by the reviewers.
• Protocol, tool, and reagent sharing: The applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including models, protocols, computational tools, biomaterials, and reagents. As one of the essential goals of the Catalyst program is to support paradigm-shifting advances, NIDDK intends that tools and reagents generated by the Catalyst program will be made broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling rapid downstream applications for the reagents by the larger scientific community. Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds(NIH Research Tools Policy (https://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage 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" (http://cde.nih.gov/) 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.

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 NOFO 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 and responsiveness by NIDDK. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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 announcement, note the following:

Applications for the NIDDK Catalyst Award (DP1) are meant to support individual scientists of exceptional creativity who propose pioneering and possibly transforming approaches that, if successful, will have a major impact on research in topics related to Diabetes, Endocrinology and Metabolic Diseases, or, in topics related to Digestive Diseases and Nutrition. 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) evidence that the proposed research is of sufficient risk/potential impact that it 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 defined as a significant departure from the direction of ongoing or previously funded research in the PD/PI laboratory.

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 National Institute of Diabetes and Digestive and Kidney Diseases, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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: General and 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:

• Federal wide 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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 NOFO.

• 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 providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/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 religious nondiscrimination laws and 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

3. 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.

4. 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 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 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: https://www.era.nih.gov/need-help (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

For Division of Diabetes, Endocrinology and Metabolic Diseases-related inquiries:

Carol Haft, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7689
Email: haftc@mail.nih.gov

For Division of Digestive Diseases and Nutrition-related inquiries:

David Saslowsky, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8876
Email: david.saslowsky@nih.gov

Najma Begum, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8894
Email: begumn@nih.gov

Natasha Loveless
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8853
Email: natasha.loveless@nih.gov

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.