Part 1. Overview Information

Key Dates

August 8, 2025 by 11:59 PM Eastern Time

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.  Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Not Applicable

Not Applicable

Conformance to all requirements, both in the the Research (R) Instructions How to Apply - Application Guide and in the NOFO, is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV of this NOFO or an applicable related Notice posted to the Guide for Grants and Contracts. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Promoting the development of safe and effective drugs and biologics to treat patients with cancer is a priority for the FDA Oncology Center of Excellence (OCE). Many advances have been made in the treatment of cancer with an increasing number of treatment options available to oncology patients. With the growing number of newer treatment approaches, such as targeted agents and immunotherapies, less is known about the differential rate and severity of rare cardiovascular side effects and toxicities, some of which may be serious and occasionally life threatening.

As many patients with cancer  are living longer, they often experience an increased symptom burden due to exposure to multiple lines of cancer therapy. Some toxicities are acute, others can become chronic, including cardiovascular complications that may manifest long after treatment has concluded. Often, the extent of the cardiovascular toxicity burden is unknown until the drug is administered to a large population of 'real-world' patients, including those with comorbidities that were not included in registrational clinical trials, or until long-term follow-up uncovers late-onset toxicities.

The natural trajectory, as well as the underlying mechanisms of many cardiovascular toxicities, is incompletely understood. Patients with pre-existing cardiovascular disease (CVD) may be at higher risk for toxicity. Thus, while it is recommended that oncologists review traditional CVD risk factors and consider the presence of established CVD, there are no clear predictors of who may experience new or worsening symptoms and toxicities and why they vary in severity and duration from one individual to another. Most cardiovascular toxicities caused by cancer treatments lack mechanistic understanding. There are challenges in objectively measuring treatment-related toxic effects, predicting risk from combination therapy, and validating pre-clinical biomarkers in the clinical setting.

Purpose and Research Objectives

There are many gaps in the current understanding of cardiotoxicity of oncology therapeutics, including a lack of definitions, methods, and approaches to monitor and characterize cardiac adverse events. There is also a need to explore approaches to predict which patients are more likely to experience cardiotoxicity, and more information is needed about the impact of cardiotoxicity on patients. The purpose of this funding opportunity announcement is to support applied regulatory science research to refine and optimize detection and monitoring of cardiovascular toxicity of oncology therapeutics.

Specific areas of interest include proposals focused on developing promising methods and approaches to characterization and monitoring of cardiotoxicity:

1. Standardized Definitions: One of the key challenges in studying and managing cardiotoxicity is the lack of standardized definitions for different types and severities of cardiotoxicity. Research is needed to create clear, evidence-based definitions that can be universally applied across studies, cancer subtypes, and clinical settings.
   • Types of Cardiotoxicity: Cardiotoxicity can present in different forms, such as myocardial dysfunction, arrhythmias, or pericardial disease.
   • Grading of Cardiotoxicity: Standardizing the grading system based on clinical outcomes, symptoms, and diagnostic criteria (e.g., heart failure, left ventricular ejection fraction).
2. Biomarkers and Imaging: Research focused on standardizing and optimizing the use of biomarkers and imaging modalities for assessing clinically relevant cardiac toxicities.
3. Functional Measures: Research is needed to define standard and reliable criteria for evaluating cardiac dysfunction.
4. Monitoring Plan: Develop a standardized cardiotoxicity monitoring plan that specifies the timing of cardiac assessments.
   • Early detection: Developing methods to detect cardiotoxicity at an early stage, before significant damage occurs, to prevent irreversible cardiovascular damage.
   • Long-term monitoring: Creating strategies for long-term monitoring of patients who have been exposed to cardiotoxic treatments, helping detect delayed or late-onset cardiotoxicity.
   • Predictive models: Research to create models or algorithms that can predict which patients are most likely to experience cardiotoxic effects, based on genetic, clinical, or treatment-related factors.

The OCE encourages engagement in collaborative networks with other research institutions and industry partners to share data, best practices, and insights. In addition, applicants are encouraged to contribute to and utilize publicly available cardiotoxicity data to enhance the generalizability of findings and support broader research efforts.

This funding opportunity is not meant to fund basic science research or non-clinical projects. The primary goal of the applied research should not be to develop a specific therapeutic product; however, additional data collection (or other expenses) applied towards investigating the specific areas of interest described above may be supported. Observational trials, or studies of approaches/ innovations to implementation within interventional trials may be supported. While the primary goal should not be to develop a novel technology, novel approaches for utilizing or adapting existing technologies in patients are encouraged.

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

Investigators proposing FDA-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign 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 not allowed. 

Applicant Organizations

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 HHS Grants Policy Statement.  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.

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.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement. 

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

For this specific NOFO, the Research Strategy section is limited to 12 pages.

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.

SF424(R&R) Cover

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.

R&R or Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

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.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

The research strategy should include a description of the specific aims and research strategy, and other research plan sections as normally required by PHS 398.

In addition, applicants should propose a plan for scientific discussions and interactions with FDA to obtain regulatory science input to ensure that the project continues to address applied science of high interest to the FDA.

Applicants should include a plan to share the findings publicly, which includes publication and dissemination plans.

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the 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 the FDA) 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 FDA-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.

Delayed Onset Study

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

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

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

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. 

Pre-award costs are allowable only as described in the HHS Grants Policy Statement. 

All research projects involving human subjects will have a restriction on use of funds for activities involving active recruitment of human subjects until both IRB approvals and FDA Human Subject Protection determinations from the FDA Office of the Chief Scientist have been completed.

Similarly, all research projects involving animals will have restrictions on use of funds for activities involving active animal research until Institutional Animal Care and Use Committee (IACUC) review has been completed for the project. There should be a formal written understanding that addresses responsibility for animal care and use, animal ownership, and IACUC review and oversight.

For some projects additional agreements and approvals (e.g., material transfer agreements, Paperwork Reduction Act (PRA) clearance) may be required before the study can proceed.

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.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to the FDA. 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 assigned FDA Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Responsiveness

The following criteria will be used to determine whether an application is responsive to this Funding Opportunity Announcement (FOA). 

• Because this FOA focuses on supporting applied regulatory science research to address specific, practical problems related to cardiotoxicity of oncology therapeutics, basic science research or nonclinical projects will not be supported.
• Direct funding of research activities focused on the development of a specific oncology therapeutic product will not be supported; however, additional data collection (or other expenses) applied towards investigating the specific areas of interest relating to cardiotoxicity described above may be supported. Observational trials, or studies of approaches/ innovations to implementation within interventional trials may be supported.
• The primary goal of the research must NOT be to develop a specific therapeutic product, or to develop a novel technology to monitor/assess cardiotoxicity; however, novel approaches for utilizing or adapting existing technologies in patients is in scope. 

Post Submission Materials

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

Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the FDA in support of the FDA mission are evaluated for scientific and technical merit through the FDA objective review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below to determine the scientific/ technical merit of the proposal.

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Is the study timeline described in detail? Is the projected timeline feasible and well justified? 

Are potential challenges and corresponding solutions discussed?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee convened by the FDA, using the stated review criteria. Assignment to an Objective Review Committee will be shown in eRA Commons.

As part of the objective review, all applications will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this NOFO.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement. 

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the HHS Grants Policy Statement. 

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

Individual awards are based on the application submitted to, and as approved by, the FDA and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). The FDA expects registration and results reporting of all trials whether required under the law or not. For more information, see the HHS Grants Policy Statement.

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

Data and Safety Monitoring Requirements: The FDA policy for data and safety monitoring requires oversight and monitoring of all FDA-conducted or supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at the HHS Grants Policy Statement and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through FDA:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in the HHS Grants Policy Statement. 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  FDA may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and HHS Grants Policy Statement.

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to HHS Grants Policy Statement for additional information. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the FDA as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.
• Primary responsibility for the scientific, technical, and programmatic aspects of the grant and for day-to-day management of the program (i.e., ensuring timeliness and adequacy of progress for all research projects and activities conducted under the cooperative agreement).
• Defining the overall research objectives and approaches.
• Determining experimental approaches, designing protocols, setting project milestones, and overseeing the conduct of experiments.l
• Overseeing the conduct of research project and ensuring scientific rigor.
• Ensuring compliance with the applicable mandatory regulations.
• Maintaining general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has appropriate clearance (e.g., appropriate Institutional Review Board (IRB) training for human subject related research) and/or background checks to work on this program.
• Adhering to policies regarding intellectual property, data release, and other policies that might be established during the course of this activity.
• Participating in regular teleconferences (e.g., monthly, bi-monthly or quarterly) with FDA program staff, including the FDA program officer and other FDA subject matter experts (to be designated as Project Scientists) to discuss preliminary results and project directions.
• Participating with FDA in a cooperative manner and providing the opportunity for FDA Program Officials and Project Scientists to review all presentations, abstracts, and manuscripts developed from the project.
• Work closely with designated officials within the recipient organization to appropriately acknowledge Federal support in publications, announcements, news programs, and other media as described in Acknowledgement of Federal Support and ensure compliance with other Federal and organizational requirements.
• Prepare background materials and meeting minutes for all meetings involving FDA participants.

FDA Program Staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Providing input on experimental and clinical approaches, assisting in designing protocols, and consulting on updates to project milestones.
• Participating in interpretation of results and conclusions and planning for public dissemination of results (e.g., publications, presentations).

3. Data Management and Sharing

Consistent with the FDA Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community, regardless of whether the recipient is an institution of higher education, hospital, non-profit or for-profit organization.

Review of Project Outputs

Awardee must provide FDA co-authored materials (such as press releases, abstracts, manuscripts and reviews supported in part or in total under this cooperative agreement) for public disclosure to OCE PO prior to disclosure or submission for publication so that the Agency can review and clear the material (within an agreed upon timeframe between FDA and the awardee). For materials without an FDA co-author, the awardee must provide the materials to the OCE PO prior to public disclosure or submission for publication to allow FDA a review of the material (within an agreed upon timeframe between FDA and the awardee).

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement. 

All FDA grants require annual financial and performance progress reports as stated in Standard Terms & Conditions of Award. This award has additional performance reporting requirements as outlined below. In addition to the RPPR, awardees are required to submit Semi-annual progress reports each year of the cooperative agreement via email to the Program Official. These reports should be documented in an agreed upon format between FDA and the grantee.

Semi-annual reports should describe progress made during the 6-month period of the cooperative agreement related to scientific progress and overall management of the project, including a summary of planned and completed presentations, abstracts, and manuscripts. A specific template and deadlines for the semi-annual reports will be provided to the grantee.

A grant closeout report and meeting will also be required at the end of the overall grant project period.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement. . FDA NOFOs outline intended research goals and objectives. Post award, the FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the HHS Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Rebekah Zinn, PhD
FDA Oncology Center of Excellence (OCE)
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Patrick Johnson
Office of Acquisitions and Grants Services
Email: [email protected]
 

Section VIII. Other Information

Recently issued policy notices may affect your application submission. A full list of policy notices is provided in the Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. 

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241), section 573(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 360ccc-2(b)) and under Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200.