NIDDK Catalyst Award (DP1 Clinical Trial Not Allowed)

NIDDK Catalyst Award (DP1 Clinical Trial Not Allowed) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-DK-26-006: NIDDK Catalyst Award (DP1 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) Funding Opportunity Title NIDDK Catalyst Award (DP1 Clinical Trial Not Allowed) DP1 NIH Director’s Pioneer Award (NDPA) March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility Assistance Listing Number(s) Funding Opportunity Purpose The NIDDK Catalyst Award is designed to complement NIDDK's traditional, investigator-initiated grant programs by supporting individual scientists who propose pioneering and transformational studies in topic areas of interest to NIDDK's Division of Diabetes, Endocrinology and Metabolic Diseases, and to NIDDK's Division of Digestive Diseases and Nutrition.

Applications should be focused on major scientific challenges and have the potential to produce an unusually high impact on diseases and conditions that are central to the mission of these two divisions within NIDDK.

To be considered responsive to this initiative, the proposed research should reflect new and novel scientific directions that are distinct from concepts and approaches being pursued in the investigator’s research program or elsewhere.

Funding Opportunity Goal(s) To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases.

Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of 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.

Notice of Funding Opportunity Description 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.

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; Applied data science and AI focus on foundational and applied research in AI, computational biology, systems biology, and bioinformatics to advance understanding of normal biological processes and diseases impacting the GI tract, liver, bile ducts, pancreas, nutrition, and obesity; HIV/AIDS research in the context of the above areas of interest; Impact of social determinants of health (SDoH) on the above conditions/diseases.

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 Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NIDDK intends to commit up to $4,800,000 in FY 2026 to fund up to six awards. Application budgets are limited to $500,000 direct costs per year. The maximum project period is 5 years.

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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information 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. Eligible Individuals (Program Director/Principal Investigator) 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . NOTE: Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will be withdrawn and will not be peer reviewed.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms. 3.

Additional Information on Eligibility 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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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: Chief, Scientific Review Branch National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Agency Routing Identifier Field: DO NOT USE. Type of Application: Must be "New".

Proposed Project: Enter start date: 7/1/2026; Enter end date: 7/1/2031 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 How to Apply - Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 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.

Other Attachments: DO NOT USE SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - 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 How to Apply - Application Guide, with the following additional instructions: Consistent with achieving the goals of the Catalyst program, the NIDDK expects that information such as study protocols and bioinformatics tools collected will be widely shared with the scientific community and made publicly available through repositories.

As part of the Resource Sharing Plan, applicants should describe prior experience in successfully implementing resource sharing policies to meet NIH sharing goals. 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 .

All instructions in the How to Apply - 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. 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 Management and Sharing Plan 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. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - 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 How to Apply - Application Guide , with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

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

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply – 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. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.

9. 1 Selected Items of Cost . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - 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 .

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