Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)

Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required) is sponsored by National Institutes of Health. Invites renewal applications of existing NINDS-supported clinical trial cooperative agreement awards requiring additional time and resources to complete the clinical trial.

PAR-25-149: Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials 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 Neurological Disorders and Funding Opportunity Title Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required) U01 Research Project – Cooperative Agreements 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 limited competition Notice of Funding Opportunity (NOFO) invites renewal applications of existing NINDS-supported clinical trial cooperative agreement awards (U01) requiring additional time and resources to complete the clinical trial.

Funding Opportunity Goal(s) To support extramural research funded by the National Institute of Neurological Disorders and Stroke (NINDS) including: basic research that explores the fundamental structure and function of the brain and the nervous system; research to understand the causes and origins of pathological conditions of the nervous system with the goal of preventing these disorders; research on the natural course of neurological disorders; improved methods of disease prevention; new methods of diagnosis and treatment; drug development; development of neural devices; clinical trials; and research training in basic, translational and clinical neuroscience.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. 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 This is a limited competition.

The National Institute of Neurological Disorders and Stroke (NINDS) invites the submission of Renewal applications of existing NINDS-supported clinical trial cooperative agreement (U01) awards requiring additional time and resources necessary to complete the active trial.

Applicants will be expected to only request what is needed both in time and additional funding necessary to complete the trial as proposed and approved for funding in the original application. Applications that include new aims will be considered out of scope and returned without a review.

Applicants are encouraged to discuss the submission of a renewal application with NINDS and seek approval to submit as necessary prior to submitting the application.

Eligible applications are renewals of existing cooperative agreement (U01) awards originally submitted under the following NIH funding announcements (NOFOs): NINDS Efficacy Clinical Trials (U01) ( PAR-17-102 ) NINDS Efficacy Clinical Trials (U01 Clinical Trial Required) ( PAR-18-422 ) NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01) ( PAR-14-220 ) NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01) ( PAR-17-274 ) NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01 Clinical Trial Optional) ( PAR-18-561 ) Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement for this NOFO. 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.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. 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 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 .

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 registration; 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.

Eligibility is limited to institutions with existing cooperative agreement (U01) awards from NINDS originally submitted under the following NIH funding announcements (NOFOs): NINDS Efficacy Clinical Trials (U01) ( PAR-17-102 ) NINDS Efficacy Clinical Trials (U01 Clinical Trial Required) ( PAR-18-422 ) NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01) ( PAR-14-220 ) NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01) ( PAR-17-274 ) NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01 Clinical Trial Optional) ( PAR-18-561 ) 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.

All applications must complete relevant sections of the PHS Human Subjects and Clinical Trials Information section of the form. Applications proposing an NIH-defined clinical trial must include the clinical trial protocol synopsis as part of the PHS Human Subjects and Clinical Trials Information section. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed.

All Key Personnel who are major contributors to the study must provide an NIH Biosketch whether or not they are budgeted. Do not include NIH Biosketches for key personnel at the coordinating centers unless they have a separate specific role in the proposed study.

The PD(s)/PI(s) of the clinical trial must be experienced in the conduct of multi-center clinical trial coordination and management, including success in meeting milestones and timelines, and have expertise in the content area of the proposed clinical trial. The experience of each PD/PI and all Key Personnel must be carefully documented and roles and responsibilities must be well-defined.

In addition, the responsibilities and authority of each PD/PI must be specified. All instructions in the How to Apply- Application Guide must be followed. This application must include all study-related costs needed to complete the existing clinical trial.

Separate itemized budgets must be prepared for each subcontract and/or for each collaborating center or core. If parts of the costs of the trial are to be provided by sources other than NIH (e.g., industry, other US or foreign funding agencies, private donation), these contributions must be presented in detail in the budget justification.

Third Party support of the proposed research activity (if approved) will be incorporated as a Special Award Condition. If the Third-Party support ceases and the trial is no longer tenable without the Third-Party support, a close-out plan may be requested.

Applicants are reminded that although Cost Sharing is not required, if these types of costs are included in the research application and peer reviewed, it is expected that these costs will not be covered by NIH. The budget for all clinical projects should be largely planned on a fee-for-service basis with detailed per-patient costs. Applicants are also encouraged to discuss their project needs with NINDS prior to submission.

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: Specific Aims: Applicants should describe the potential impact of the proposed research.

The hypotheses and specific aims of the research must be clearly and concisely stated. The primary and secondary outcomes to be measured must be defined. The inclusion of secondary aims should be justified by describing the importance of the supportive or explanatory data.

Significance : Applicants must concisely state the need, rationale, timeliness, and scientific relevance of the proposed study. The application must present an overview of the state of the science, therapeutics for the disease, and continued relevance of the question being addressed in the existing clinical trial. The applicant should include any new data or evidence in the field that supports the continuation of the current study.

It is particularly important that there be a discussion of how results of the study (positive or negative) will advance and or impact current research in this field with the additional time needed to complete the study. The applicant should also identify other ongoing or planned study (industry or academic) that had been initiated since the trial was started and discuss the overlap , if any.

Current status and report of progress to date in the trial: Applicants should provide a description of the progress in the trial, including a discussion of challenges or delays resulting in the need for the project extension to complete the study.

In addition, the applicants must describe any modification to the study design or corrective actions the study procedures that have been implemented since the study was initially funded and discuss how these modifications or actions will ensure completion of the study within the next funding period.

Approach: Applicants should provide a concise summary of the current protocol and identify any significant changes from the originally funded study including the items listed below. Information that is required as part of the PHS Human Subjects and Clinical Trials Information Form need not be described in detail in this section; specific details can be referenced to the PHS Human Subjects and Clinical Trials Information Form.

Include a summary of the following: A description and rationale for the selected study design. Rationale for selecting the study population (as described in section 2 of the Human Subjects and Clinical Trials Information form) and why it is an appropriate group to answer the question under study. Rationale for selection of the intervention(s) to be tested and study outcomes and endpoints (for clinical trials).

Rationale for inclusion/exclusion criteria, or of group eligibility criteria (for group-randomized trials). A description of all assessments, including clinical, laboratory, physiological, behavioral, patient-centered, or other outcomes addressing the primary and secondary research questions. A discussion of potential biases and/or challenges in the protocol and how they will be addressed.

Data management procedures and plans for including new sites, if applicable. Study organization and governance A statement of commitment from each participating institution or organization to the PD/PI that demonstrate how the institution or organization will support the PD/PI's efforts to complete the trial must be provided.

Additionally, provide a cover page in the application listing the names and institutions of all letters of support providers. If there will be subcontracts or service agreements for personnel or facilities, include documentation of such commitments, co-signed by a business official and the investigator at the participating center.

If there are agreements with collaborating industry partners, include documentation of the agreements, co-signed by a business official and an appropriate official at the company. If CTSA resources will be utilized, include letter of support from each site CTSA program officer concurring with the specific plan for using these resources.

If some trial costs are to be borne by sources other than NIH, include documentation of this support, signed by individuals who have the authority to make a commitment on behalf of the organization they represent. Applicants are encouraged to include letters from patient organizations or other supporting documentation to show that patients were included as partners in the concept development and design of the trial.

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-definedclinical 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 2 - Study Population Characteristics 2.

3. a Inclusion of Individuals Across the Lifespan Applicants must include a plan to enroll individuals across the lifespan. Considerations that may contribute to successful inclusion are appropriate site selection, patient-or community-engagement for the major elements of the projects, use of focus groups to address barriers to inclusion, etc. 2.

4 Inclusion of Women and Minorities Applicants must include a plan to enroll women and minorities (as appropriate). The plan must also consider translation of all the study-related documents to enroll non-English speaking participants.

Considerations that may contribute to successful inclusion are appropriate site selection, patient- or community-engagement for the major elements of the project, use of focus groups that include women and minorities consistent with the NIH Inclusion Policies to address barriers to inclusion, etc. 2.

5 Recruitment and Retention Plan Applicants must include a discussion of the ability of sites to recruit and retain the proposed number of participants, including women, minorities, and individuals across the lifespan.

Evidence should be provided that relevant collaborators (e.g., potential participants, referring and treating physicians, patient groups) have equipoise, view the question to be important and consider the study acceptable. Applicants should survey all the potential clinical sites to ensure that recruitment targets can be met considering the proposed inclusion/exclusion criteria.

Present the survey results using a table where the rows represent potential clinical sites and the columns include responses to questions from the survey. The survey questions will depend on the nature of the trial and the protocol-specified screening procedures but might include these: Has the PD/PI previously recruited patients with this disease into a clinical trial (if applicable)?

Does this site have all necessary equipment to complete eligibility evaluations? If not, how far (in miles) will patients need to travel to complete eligibility evaluations? What is the total number of patients seen at this site in the past 12 months?

How many of these appear to meet the pre-screening eligibility criteria? How many of these are likely to be found fully eligible and consent to be enrolled? Does this site have experience enrolling and following with participants with limited English proficiency?

What plans are there to enroll from the appropriate populations? Applicants should provide detailed study performance and timeline objectives to complete all activities in the trial within a five-year period.

Milestones of particular interest may include, but are not limited to: Enrollment of the remaining study participants, including break-down of women, minorities, and individuals of all ages, including children and older adults (as appropriate) Study closure and completion plans Completion of data collection Completion of primary endpoint and secondary endpoint data analyses Completion of final study report Publication of primary study results Reporting of results in ClinicalTrials.

gov Submission of final public use dataset to NINDS Milestones and timelines will be refined and finalized in consultation with Program staff at the time of award. Section 3 - Protection and Monitoring Plans 3. 3 Data and Safety Monitoring Plan Applicants should refer to the NINDS Guidelines for Data and Safety Monitoring in Clinical Trials ( https://www.

ninds. nih. gov/Funding/Apply-Funding/Application-Support-Library/NINDS-Guidelines-Data-and-Safety-Monitoring ) when developing their DSMP.

3. 5 Overall Structure of the Study Team Describe a Clinical Site Monitoring Plan including how site adherence to the protocol and consenting process will be ensured, who is responsible for site monitoring, the frequency of planned monitoring activities, and the plan for handling deficiencies. Also describe plans for training and, if needed, certifying site personnel to complete study procedures.

Describe the methods and systems for data collection and quality control, and for ensuring data confidentiality and privacy, and the process for locking the final dataset. Describe the plans, if any, to use non-traditional data collection approaches (e.g., digital/mobile/sensor technologies and web-based systems) and why these are appropriate. Describe the composition and role of any advisory committees.

Discuss the responsibilities, oversight and coordination of any centers or cores. Describe any subcontracts or service agreements for personnel or facilities. Section 4 - Protocol Synopsis Applicants should identify any changes in the study design that have been implemented since the original submission.

4. 1. a.

Detailed Description As applicable, state how the following resources for clinical research will be utilized: NINDS Common Data Elements ( https://www. commondataelements. ninds.

nih. gov/#page=Default ) NeuroQOL ( http://www. healthmeasures.

net/explore-measurement-systems/neuro-qol ) NIH Toolbox ( http://www. healthmeasures. net/explore-measurement-systems/nih-toolbox ) PROMIS ( http://www.

healthmeasures. net/explore-measurement-systems/promis ). If applicable, include a statement regarding how Clinical and Translational Science award (CTSA) program resources will be leveraged.

Describe what CTSA services will be used at each participating CTSA site and how the use of the CTSA impacts the trial budget. For trials at any stage, state the go/no-go criteria that will be used to decide whether to proceed with a subsequent clinical trial. 4.

3 Statistical Design and Power Applicants should provide a Statistical Analysis Plan (SAP), including details on the analyses specified in the study protocol, including a description of how the statistical analysis of the primary, secondary and other endpoints will be performed, how the sample size was determined, how missing data will be handled, plans for interim analyses for safety, efficacy and futility, plans for recalculation of the sample size midway through the trial (if applicable), and other measures to ensure rigor and transparency of the analysis.

If computer simulations were used to investigate the operating characteristics of complex clinical trial designs (such as adaptive designs), to choose between alternative outcome measures, or to determine sample size, accounting for the impact of non-compliance, missing data, subject eligibility criteria, etc., sufficient details about the simulations should be provided in the SAP.

It is particularly important to discuss the range of conditions that were considered in the simulation and why this range was considered appropriate, how robust the findings were across the range of conditions considered, and how the study will adjust for any design deficiencies (e.g., bias, loss of power) the simulations revealed. 4. 5 Will the study use an FDA-regulated intervention?

4. 5. a.

If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status. Any correspondence from FDA must be included in the application. Section 5 - Other Clinical Trial-related Attachments 5.

1 Other Clinical Trial-related Attachments IRB Communications (Optional 5 pages max). Submissions that exceed this limit will not be accepted: This attachment should be entitled IRB Communications. pdf.

Applicants should submit relevant approval letters and associated attachments.

FDA Communications (Optional - 10 pages max): Applicants should include a summary (1-page maximum) of interactions with the FDA, supported by the following associated and attached documentation: Approved minutes from all pre-submission meetings Notice of IND or IDE approval and any associated attachments Communications on official FDA letterhead Email communications with substantive information regarding the drug, biologic, device (or other intervention) review, or outcome.

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 .