Cancer Prevention and Control Clinical Trials Planning Grant Program (PAR-25-103)

Cancer Prevention and Control Clinical Trials Planning Grant Program (PAR-25-103) is sponsored by National Cancer Institute (NCI). This program provides planning grants for clinical trials related to cancer prevention and control. Universities conducting psychosocial oncology research that aims to develop and test interventions could utilize this for planning future clinical trials.

PAR-25-103: Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional) 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 Cancer Institute ( NCI ) Funding Opportunity Title Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional) U34 Planning Cooperative Agreement 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 Through this notice of funding opportunity (NOFO), the National Cancer Institute (NCI) intends to facilitate well planned clinical trials across the cancer prevention and control spectrum aimed at improving prevention/ interception, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and the long-term outcomes of cancer survivors.

Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, accrual challenges, intervention, outcome/ endpoints, data/statistical challenges or operational risks necessary to finalize the trial protocol completely.

These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent study completion. Further, the suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, at-risk group, symptom or venue.

Preparatory studies may fill information gaps and address unknowns this can include a pilot/feasibility clinical trial if necessary, improving trial design and rigor. 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 This notice of funding opportunity (NOFO) will support studies for the acquisition of data critical to completing the protocol of a full-scale multi-center Phase II or later phase trial.

Applicants must describe the proposed future clinical trial and identify the specific issues for which additional data would be beneficial in planning a feasible future trial. Preliminary efficacy or effectiveness data to justify the future intervention trial must already exist at the time of application.

Although the scientific literature or preliminary data may provide the rationale for conducting a future clinical trial, investigators often lack critical information about the study population, intervention, outcome, or operational risks necessary to finalize the trial protocol completely.

The immediate goal is that the proposed planning activities will yield information that is both scientifically necessary and also sufficient to permit final decisions about the design or conduct of the clinical trial that increase rigor and feasibility. Preliminary studies may be needed to fill information gaps and address unknowns.

This can include a pilot/ feasibility clinical trial if necessary, thereby improving future trial design and rigor. Unlike the R21 mechanism that is intended to obtain data that will support a future R01 grant, the U34 mechanism cannot be used for the collection of preliminary efficacy or effectiveness data to support the rationale for the subsequent clinical trial.

Rather, the U34 mechanism may support planning activities to collect feasibility data, additional efficacy or effectiveness data, test accrual strategies, and address study design questions for a future trial. The information obtained using a U34 planning grant is intended to address issues that allow investigators to make decisions about whether the future trial should progress and, if so, what study design changes are necessary.

Development of this U34 mechanism is meant to fill a gap in cancer prevention and control trials and facilitate study through our NCI-funded prevention and control clinical trials networks including but not limited to ULACNet, CP-CTNet, and NCORP. The activities required will depend on the type of study (e.g., screening study, drug/device/biologics trial, behavior intervention, cancer care delivery).

A pilot/ feasibility trial is allowed but is not required and should only be included if it is essential to the goals of the project. Examples of research needs include but are not limited to the following: Perform studies to refine the appropriate study population, intervention, outcome, and/or study endpoint.

Collect information necessary to identify appropriate recruitment methods and estimate available populations, screening-to-enrollment yield, attrition rate, or response rate with a focus on ensuring an appropriately complex and adequate study population. Adapt and test an intervention or outcome instrument for a population that differs from the population for which the instrument was originally designed and evaluated.

Identify the appropriate control or comparison group to use in the subsequent clinical trial. Modeling data to support trial assumptions in the study design. Statistical planning and design Standardize the intervention or outcome across multiple sites.

Test the feasibility of an outcome or intervention in the field. Determine the acceptability of the intervention to study participants. Determine whether adequate adherence to the intervention is achievable.

Standardize and validate survey instruments. Develop methods for measuring intervention fidelity. Standardize and test the effectiveness of training tools.

This NOFO is intended to support applications that address research questions that are within the mission of the Division of Cancer Prevention or Division of Cancer Control and Population Sciences .

Examples of relevant areas of research include but are not limited to : Cancer prevention and interception : testing of interventions (including nutritional compounds, drugs, small molecules, vaccine and biologics) and approaches (including medical devices, cancer preventive surgery, risk-reducing surgery, and non-surgical ablative techniques) to block, reverse, or delay the early stages of cancer (including treatment of preneoplastic lesions).

Cancer screening : studies of clinical impact (harms as well as benefits) of cancer early detection technologies and practices, such as imaging and molecular biomarker approaches; Early detection : clinical utility of biological markers for early cancer detection and cancer risk assessment; Behavioral research in cancer prevention and control : testing of interventions addressing cancer risk behaviors such as: tobacco use, obesity prevention and management, sedentary lifestyles and poor diets; UV exposure; alcohol use.

In addition, interventions of interest include those designed to improve vaccine uptake; immune function; sleep and circadian function; screening behavior; adherence to cancer prevention or treatment regimens; biopsychosocial processes of cancer-related behavior; communication and shared decision-making; environmental modifications and policy changes aimed at altering cancer-related health behaviors and/or preventing or improving cancer-related risks and outcomes; Susceptibility to cancer and cancer-related outcomes : strategies to translate clinical, environmental and genomic/genetic determinants of cancer occurrence and outcomes into evidence-based interventions for clinical and public health practice; Implementation science : strategies to promote the adoption, implementation, and sustainability of evidence-based intervention into routine healthcare and public health settings or the deimplementation of ineffective interventions; Healthcare delivery : single and multi-level interventions addressing the organization and/or delivery of cancer care (e.g., team-based care; novel use of electronic health records; new organizational mechanisms/staffing such as patient navigation; new models of specialized services such as palliative care or survivorship programs); Cancer survivorship : interventions addressing the physical, psychological, social, and financial burden of cancer and its treatment among survivors of cancer and their families (e.g., social functioning, caregiver adaptation); Supportive and palliative care : care/symptom science: intervention studies to prevent or treat acute and chronic symptoms and morbidities related to cancer and its treatment (e.g., cancer-related pain, chemotherapy induced peripheral neuropathy, cardiotoxicity, neurocognitive deficits, fatigue, sleep, etc.) as well as studies addressing the psychological impact of cancer and its treatment (e.g., stress, anxiety, depression); and/or Quality of Life (QOL) : studies to improve the QOL (physical, functional, emotional, psychological, and social well-being) of patients.

Non-Responsive Applications Applications with the following attributes will be deemed non-responsive and will not be reviewed: Applications that are first-in-human studies. Applications that only propose to write a protocol or manual, develop infrastructure, or implement an already fully designed trial. Applications that include purely mechanistic work or contain animal studies.

Applications that lack a milestone plan or a future clinical trials description. Applications for an intervention without preliminary efficacy or effectiveness data. 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 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.

Optional: Accepting applications that either propose or do not 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 limited to $225,000 per year and $450,000 in direct costs over the 3-year project period without a clinical trial. Applications that include a pilot/ feasibility clinical trial are limited to $225,000 per year and $600,000 in direct costs over the 3-year 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) Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

Milestone Plan : The filename "Milestone Plan. pdf" should be used and the attachment should not exceed 2 pages. The applicant is required to provide detailed information and timelines for completing all necessary planning activities.

Milestones should be easily measurable and realistic. Milestones for meeting the requirements of the network through which the study will be conducted must be included. This plan should detail how the team will work with the research base or LAO to accomplish these milestones.

Milestones may include, as applicable, but are not limited to: Development of a Manual of Operations Development of case report forms Development of the research team Identification of studysites Identification of a central laboratory and other relevant service cores Development of study organization and governing principles, if appropriate, including a Publications Policy and an Ancillary Studies Policy Development of training materials and policies for staff certification and site initiation Establishment of a single IRB and initiation of the IRB approval process Plans for obtaining study drug, other intervention materials, or placebo if appropriate Obtaining an Investigational New Drug Application or Investigational Device Exemption, if appropriate These milestones will be negotiated at the time of the award, as appropriate.

The Milestone plan is a separate document from the Study Timeline. Future Clinical Trial Description: The filename "Future Clinical Trial Description. pdf" should be used and the attachment may not exceed 3 pages.

Provide a description to the extent known of the future clinical trial to provide context for information sought in the U34 award . The summary should not describe the pilot/feasibility trial that may be conducted during the U34 period of award. 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: Specific Aims: The goals and expected outcome(s) of the planning activities should be concisely stated in the Specific Aims section. These should be explicitly linked to specific objectives of the future trial. Research Strategy: This section must address both the planning activities and the future trial.

The Research Strategy must include: A discussion of the significance of the problem being studied, the need for the future trial, and the potential impact of the results of the future trial; Sufficient details of the future clinical trial (e.g. study design, primary objective, inclusion and exclusion criteria, proposed study population, proposed study agent(s), preliminary sample size, primary and major secondary endpoints, duration of recruitment and follow-up, etc.) to allow assessment of the likelihood that a feasible clinical trial will be developed;The statistical methods, including the assumptions made for preliminary power calculations for the future study, must be described.

The sample size and statistical power calculations must contain adequate detail for duplicating the analysis readily.

The power analysis should include a discussion of the anticipated level of adherence to the intervention and rates of follow-up (i.e., drop out/lost to follow up) during key outcome collection contacts; Details of any pilot/ feasibility clinical trial that will be conducted as part of the award and the metrics that would signify success; A description of the potential problems, alternative strategies, and benchmarks for the success of the planning activities and future trial; A description of the planning activities to be carried out including stakeholder engagement; A discussion of how the proposed activities address any major barriers to the timely and successful implementation of the future trial; Information about how the future trial documents, and planning trial documents (if applicable), will be developed; A description of how the trial will be organized and managed, including the plans to identify and select additional collaborators, if applicable; and A concise description of the milestone plan.

Letters of Support: Provide all appropriate letters of support for the planning activities, including any letters necessary to demonstrate the support of consortium/site participants including the research base or Lead academic organization (LAO) that will support the future study, cores, laboratories, pharmacies, and other collaborators, including cost-sharing by NIH resources, in the case of intramural collaborators.

If co-funding or in-kind support is planned from any source (non-NIH sources or NIH sources), letter(s) outlining details of the commitment (e.g. type, amount, and source of support), signed by a business official on organization letterhead, must be included. Letters of support should also be provided from individuals or organizations that have been or will be involved in stakeholder engagement efforts.

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. The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 2 - Study Population Characteristics 2.

5 Recruitment and Retention Plan (for the planning study) Recruitment and referral sources: include the number of potentially available participants per proposed site annually; Enrollment rate (e.g., number of participants meeting eligibility criteria for enrollment per month); Discussion of potential recruitment delays or challenges and alternative strategies that can be implemented if there are enrollment delays or shortfalls; Procedures to monitor enrollment and track/retain participants for follow-up assessments; Evidence to support the feasibility of enrollment, including prior experience and yield from research efforts using similar referral sources and/or strategies; Strategies to ensure the study population has scientifically appropriate complexity and representativeness; Decision points for terminating the trial.

The study timeline should describe key milestones throughout the planning study, not the future trial, that needs to be met to achieve the goals of the study. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a project stage or activity. Applicants are required to provide detailed project performance and timeline objectives as outlined below.

Program staff will review the milestones and timelines which can be negotiated, as needed, at the time of the award. This section should include an estimated timeline for the following general milestones of the planning study, as applicable: Registration of clinical trial in ClinicalTrials.

gov; Completion of regulatory approvals; Enrollment of the first subject; Enrollment of 10%, 25%, 50%, 75%, and 100% of the projected recruitment for all study participants including women, minorities, and children (as appropriate); Completion of data collection time period; Completion of primary endpoint and secondary endpoint data analyses; Completion of the final report of the primary outcome; Reporting of results in ClinicalTrials.

gov; Status of the FDA-regulated product requiring IND or IDE if applicable. In addition to meeting the above recruitment and other targets, applicants should give contingency plans if they do not meet the milestones and address other implementation activities necessary such as start-up tasks to achieve trial completion. Future year support is contingent on the satisfactory achievement of performance milestones.

If milestones are not achieved fully, NCI may request the development of a remedial plan and more frequent monitoring of progress, and/or take other remedial actions. Section 4 - Protocol Synopsis 4. 1.

a Detailed Description It should summarize the necessary elements of the planning study, not the future trial, and supplement the Research Strategy, which includes an overview of the state-of-science and relevance of the trial. Please include the dose and intensity of the intervention in the description, if applicable. 4.

3 Statistical Design and Power The sample size and statistical power calculations should contain enough detail about the planning study, not the future trial, including sufficient information on the assumptions made so that a reviewer can readily duplicate the projected sample size for primary and secondary endpoints related to feasibility.

The power analysis should include a discussion of non-compliance, potential cross-over (if applicable), account for rates of follow-up (i.e., drop out/lost to follow up) during key outcome collection contacts. A discussion of how missing data will be handled should be included. 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. Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide.

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.

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