Exploratory Clinical Trials Grants Program

Exploratory Clinical Trials Grants Program is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). This program supports early-stage clinical trials (e. g.

, first-in-human, dose-finding, safety/efficacy) for drugs, biologics, devices, behavioral interventions, and/or physical therapy for the treatment of arthritis, musculoskeletal, or skin conditions or diseases.

PAR-24-279: Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required) 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. 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 Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Funding Opportunity Title Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required) R61 Phase 1 Exploratory/Developmental Grant Notices of Special Interest associated with this funding opportunity 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 This Notice of Funding Opportunity (NOFO) is designed to facilitate clinical trials that can be completed within a limited time frame. A broad range of types of exploratory studies may be submitted to this NOFO.

The trials must address research questions related to the mission and goals of the NIAMS and may evaluate interventions with drugs, biologics, devices, or surgical, dietary, behavioral or rehabilitation therapies. Open Date (Earliest Submission Date) 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 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.

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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. 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 goal of the NIAMS clinical trial program is to support research leading to the prevention or reduction of symptoms and improve outcomes and function in patients with rheumatic, musculoskeletal, or skin conditions or diseases.

The purpose of the Exploratory Clinical Trials Grants Program is to foster clinical trials that will lead to clinically meaningful improvements in prevention, diagnosis, or treatment of these conditions or diseases. This Exploratory Clinical Trials Grants Program is designed to facilitate the execution of short-term, interventional studies.

The Program is intended to support a range of exploratory studies, from proof-of-concept/first in human to Phase I and Phase II clinical trials. Such studies must meet the NIH definition of a clinical trial and be feasible within the time and budget constraints of this NOFO.

A high priority is the use of such studies to stimulate the translation of promising research developments from laboratory, preclinical, and early human testing into clinical practice. The proposed study should be supported by a strong scientific rationale.

Preliminary data specifically related to clinical effect of the proposed intervention in the targeted condition are not required for R61 applications; however, they may be included if available. All included preliminary data will be evaluated by the reviewers.

Examples of research areas of interest include, but are not limited to: Conducting early-stage clinical trials, such as but not limited to; first in human, dose-finding or escalation/tolerability/safety/efficacy studies with drugs, biologics, devices, behavioral interventions, and/or physical therapy for treatment of arthritis, musculoskeletal, or skin conditions or diseases.

Clinical trials to provide data required to support a future, more robust clinical trial whose aim is to help establish the safety and efficacy or effectiveness of an intervention. Clinical trials in rare diseases where the number of potential study participants is limited. Clinical trials to determine the predictive value of a potential biomarker.

Applicants should take note of the following: Consultation with NIAMS: Applicants are encouraged to consult with NIAMS staff as plans for an application are being developed (see Section VII, Agency Contacts). This early contact will provide an opportunity to clarify NIAMS policies and guidelines.

Also, discussions regarding how to develop an appropriate project timeline, milestone plan, and strategies for recruitment and inclusion of women and minorities are available. Efficacy/Effectiveness: This NOFO is not intended to support the conduct of a large-scale clinical trial where the primary aim is to establish or confirm robust efficacy or effectiveness.

Information for applicants to implement definitive efficacy trials (e.g., Phase 3 trials of drugs or pivotal device trials) can be found at: https://www. niams. nih.

gov/grants-funding/conducting-clinical-research/investigator-clinical-trial-policies Rationale: The rationale for a trial should be based on: 1) unmet medical need(s); and/or 2) plausible biological mechanism(s); and/or 3) compelling preclinical ( in vivo, ex vivo and/or in vitro ) data. If available, preliminary clinical data can be presented.

Scientific Rationale: There should be a discussion of the scientific rationale for the trial and how it supports the need to test the proposed hypothesis or intervention should be included; the scientific rationale should be well supported by preliminary data, and/or information in the literature, and/or knowledge of biological mechanisms. Rigor: Is the prior research that serves as the key support for the proposed project rigorous?

The strengths and weaknesses in the rigor of the prior research that serves as the key support for the proposed project should be described. There should be plans included to address weaknesses in the rigor of prior research that serve as the key support of the proposed project.

Enrollment: The proposed study cohort should match the diversity of the population affected by the disease, otherwise the application may be considered low priority by the NIAMS. Exploratory Investigational New Drug (IND)/Early Feasibility studies: The proposed project may be an exploratory IND study with very limited human exposure as defined by the FDA.

Applications Not Responsive to this PAR The following types of applications sent in response to this PAR will be considered non-responsive: Applications not addressing research questions related to the NIAMS mission and goals. Applications not evaluating interventions. 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 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.

Required: Only accepting applications that propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The combined budget for direct costs for the three-year period may not exceed $600,000. No more than $300,000 direct costs may be requested in any single year. The scope of the proposed project should determine the project period.

The maximum project period is three 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 the 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. This NOFO does not require cost sharing as defined in the 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 Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. 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. 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.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. 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: The specific aims of the exploratory clinical trial must be clearly and concisely presented. The primary and major secondary hypotheses to be evaluated must be clearly stated.

Clinical Significance and Biological Relevance: The significance and, when applicable, the biological relevance of the proposed clinical trial must be clearly stated. It is particularly important that there be discussion of how the trial will test the primary hypothesis and how the results of the trial (positive or negative) will advance the field.

The application should explain, if applicable, why the proposed trial is necessary to plan subsequent studies. Scientific Rationale/Premise: A discussion of the scientific rationale for the trial and how it supports the need to test the proposed hypothesis or intervention must be included. The scientific rationale should be well supported by preliminary data, information in the literature, and/or knowledge of biological mechanisms.

Prior Studies and Rationale for Development: The major findings of the preclinical and/or clinical studies that led to the proposed clinical trial should be described accordingly to support the rationale for the trial. Pilot studies that show the need for and the feasibility of the trial should also be discussed.

Study conceptualization and planning must be at a stage sufficient to allow for an assessment of the likelihood of trial success. Applicants should address the reasons for consideration of the intervention. This may include preclinical in-vitro and/or in-vivo data.

Animal efficacy data should be included in the rationale only when the model and read-out are considered sufficiently associated with the human condition.

Other considerations that should be discussed, if applicable, are: toxicology data (e.g., whether the FDA has found the toxicology data to be acceptable to proceed with the proposed trial); medicinal chemistry/pharmacology data (e.g., whether the formulation is feasible and the pharmacokinetics acceptable for use as intended in the trial); regulatory considerations [e.g., details on FDA, European Medicines Agency (EMA), and other agencies' evaluations; discussion of the likelihood of regulatory approval based on acceptability of endpoints, orphan drug status, etc.]; public health impact; ethical dimensions; and patient perspectives on acceptability of the proposed intervention.

Characteristics of any preliminary research results provided in support of the proposed project, whether conducted by the applicant or others, should be described in the application so that peer review may evaluate the strength of the supporting evidence. If preclinical data (e.g., animal studies) supporting evidence for the trial are not conclusive, the applicant should discuss the limitations of those data.

In addition, applications should outline specific plans for future development, if applicable, in the event of promising results. Applicants should include a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.

A discussion of the trial protocol, which augments but does not repeat information from the clinical protocol synopsis, must be presented and must include the items listed below: Discussion of the potential biases in the study and how they will be addressed.

Inclusion of, whenever possible, an evaluation of early signals of activity utilizing biomarkers or surrogate endpoints that mechanistically test the activity of an intervention in terms of its presumed target. The use of early signals as primary outcomes is allowed, if sufficient solid rationale exists for their selection and the information is appropriately documented in the application.

Letters of Support : Applicants are encouraged to include supporting documentation to show that patients were included as partners in the concept development and design of the trial. This evidence may be supported by letters from stakeholders (e.g., professional organizations or patient groups).

Applicants are also encouraged to include documentation of the commitment of any subcontractors, companies providing study agents or other resources for the trial, or consultants as well as service agreements for personnel or facilities. Letters of commitment must be co-signed by the business official of the collaborating center.

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.

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. 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. Section 3 - Protection and Monitoring Plans 3.

3 Data and Safety Monitoring Plan Note that if an application is awarded, the NIAMS will appoint an independent monitoring body which may include, a Data and Safety Monitoring Board (DSMB) or Safety Officer(s) (SOs) based on the risks and complexity of the trial. For more information about NIAMS requirements for Data and Safety Monitoring, please see: https://www. niams.

nih. gov/grants-funding/conducting-clinical-research/data-safety-guidelines-policies. Section 5 - Other Clinical Trial-related Attachments 5.

1 Other Clinical Trial-Related Attachments The application must contain the following information, according to the instructions below, to provide evidence that the investigator(s) has planned a feasible clinical trial. The information provided here supports the Research Strategy and should not duplicate it. The following documents must be uploaded as separate PDF files with unique names and should be appended as needed.

Example: Document may be titled, "Clinical Monitoring and Data Management Plan1. pdf" for study record 1, etc. 1. Clinical Monitoring and Data Management Plan : The Clinical Monitoring and Data Management Plan is a required attachment and must use the filename "Clinical Monitoring and Data Management Plan.

pdf." Applications lacking this attachment will be considered incomplete and will not be reviewed. Each Clinical Monitoring and Data Management Plan includes two parts: (A) The Clinical Monitoring Plan for the quality assurance of the proposed clinical trial through clinical data monitoring activities, and (B) the Data Management Plan for the quality controls proposed through data management activities.

Part A: The purpose of the Clinical Monitoring Plan is to verify that the clinical trial is being conducted and documented in accordance with the Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

The Clinical Monitoring Plan must include the following: Description of the persons/entity responsible for conducting the clinical monitoring (e.g., contracted Clinical Research Associate, Data Coordinating Center, independent study monitor from the Clinical Coordinating Center) Description of the frequency of planned monitoring activities (e.g., Study Initiation, Interim Visits, Study Close Out), locations where the monitoring will occur (e.g., participating clinical sites, data center, clinical coordinating center) and what data will be reviewed An overall description of the monitoring plan to ensure adherence to the protocol, adequate documentation of the consenting process, and the quality and consistency of the study intervention(s), including fidelity monitoring for behavioral interventions.

Description of methods to monitor study data collected and systems to record and manage exceptions and deviations. If applicable, a description of monitoring of participating facilities such as labs or pharmacies for adequate handling and storage of the investigational product(s) and study specimens.

If applicable, a description to assure that the investigational product(s) accountability and reconciliation are performed adequately during and at the end of the trial per applicable regulatory requirements; Description of plans for handling any deficiencies that are uncovered and in cases of serious deficiencies the appropriate reporting to relevant authorities, including but not limited to the IRB of record, DSMB if one is assigned, FDA if applicable, institutional officials, and the NIH.

Part B: The purpose of the Data Management Plan is to ensure that validated systems and controls are in place to assure the integrity of the clinical research data being collected for the proposed study.

The Data Management Plan must include the following: Description of methods and systems for data collection (e.g., Case Report Forms/CRFs), data entry, data verification and data validation; Description of the data query process and frequencies and any planned mitigation strategies in the event of noncompliance; Description of methods and systems to ensure data confidentiality and subject privacy; Description of process for locking the final trial datasets and the planned procedures on data access The NIAMS requirements for clinical monitoring and data management for clinical trials as described above are in addition to the application's Data and Safety Monitoring Plan (DSMP) provided in section 3.

3 of FORMS-H , which describes how research participant safety and data in the trial will be monitored by an independent monitoring and oversight entity. 2. Intervention Documents : The Intervention Documents attachment is required and must use the filename "Intervention Documents.

pdf." Applications that lack an Intervention Document attachment will be considered incomplete and will not be reviewed.

The Intervention Documents should include one of the following documents according to the type of intervention(s) to be used in the proposed clinical trial: Investigator's Brochure or Product Label/Package Insert (provide for trials in which the intervention is a device, drug, or biologic), which comprises a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects and provides information on the risk of the intervention; Intervention Monitoring Manual(s) (provide for trials in which the interventions are behavioral or social), which consists of a document that describes in detail the content and delivery of the intervention.

The intervention manual should describe how to conduct the intervention, how to train the interventionists, how to monitor fidelity in delivering the intervention, and the rationale for the specified intervention. There is no page limit for these attachments, however, the materials provided must specifically address only the Clinical Monitoring and Data Management Plan and the Intervention Documents.

Do not include information that is requested in another section of the application. Applications that include materials not requested in the attachments may be withdrawn. 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. 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 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. 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 . 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.

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 How to Apply Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIAMS, NIH . Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]