National Institutes of Health (NIH)
R21 Exploratory/Developmental Research Grant
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits grant applications proposing to utilize bacteria, archaebacteria, bacteriophages, or other non-oncolytic viruses and their natural products to study the underlying mechanisms of the complex interactions between microorganisms, tumors, and the immune system, and to explore their clinical potential for cancer imaging, therapeutics or diagnostics. Projects can focus on using microorganisms as anti-tumor agents, as activators of anti-tumor immunity, or as delivery vehicles for treatment, diagnosis, or imaging, complementing or synergizing with existing tools and approaches. This NOFOwill support basic mechanistic and preclinical studies in cell culture and animal models. Applicants are encouraged to address both the microbial and tumor aspects of microbial tumor interactions relevant to microbial-based cancer therapy (including therapies for oral cancer), tumor imaging, tumor detection, or diagnosis
This funding opportunity is part of a broader NCI-sponsored research on microbial based cancer therapy.
Not Applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
February 16, 2025 * | March 16, 2025 * | Not Applicable | July 2025 | October 2025 | December 2025 |
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.
Not Applicable
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.
IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) encourages grant applications to study novel microbial-based cancer therapy (including therapies for oral cancer), imaging detection, and diagnosis strategies to overcome the limitations of inadequate conventional cancer imaging and therapies. Solutions may utilize bacteria, archaebacteria, bacteriophages, and other microorganisms and their products (but not oncolytic viruses).
This NOFO utilizes the R21 award mechanism for exploratory/developmental projects. The R21 mechanism is suitable for projects that are at their inception, conceptual, or idea-based phase where proof-of-principle of the proposed methodology has not been established with the aim to demonstrate core functional capabilities of the proposed approach. In this phase, the technical feasibility of the proposed technology or methodology should not yet have been established.
This NOFO runs in parallel with a companion NOFO, PAR-25-107 , which uses the Research Project (Grant R01) mechanism. It is the appropriate NOFO for more mature applications that include preliminary data that demonstrate the feasibility of the specific aims.
Background and rationale Early clinical observations in the 1880s by Coley pioneered the concept of using bacteria (or their products) as microbial-based cancer therapy and demonstrated that tumor regression coincided with natural bacterial infections, leading to the first use of microbes as antitumor agents. With the development of the more effective and better-understood radiation therapy, and later, chemotherapy-based cancer therapies, this approach was largely abandoned in the 1930s and microbial-based therapy has remained an elusive goal. However, standard cancer therapies have several major disadvantages, including the rarity of complete and sustained remissions of most solid tumors, the development of resistance, frequent failure to clear micrometastases, and relapse. To overcome the limitations of current cancer imaging and therapies, microbial tumor homing and colonization, oncolysis, and activation of anti-tumor immunity are being explored as alternative strategies. Because Bugs as Drugs are potentially self-regenerated cancer therapeutics, the approach may address cancer therapy needs for global health and low resource settings
Mechanisms of microbial-based Cancer Therapy
Several facultative or obligate anaerobic bacteria possess unique natural or genetically engineered potential to overcome traditional therapeutic limitations by selectively targeting tumors and/or anti-tumor immunity. For example, Salmonella, Escherichia coli, Clostridium, Bifidobacterium, or Listeria are naturally capable of selective homing to tumors when systemically administered, resulting in high levels of colonization and replication in locally hypoxic tumor microenvironments or within tumor tissues leading to killing tumor cells, reprograming the immune system to target cancer cells. Therapeutic bacteria can stimulate the production or localized in the tumor of CD8+T lymphocytes or block immune checkpoint pathways.
Microbial products (including microbial toxins) and microbial metabolites are also associated with anti-tumor activities. Microbial metabolites can inhibit tumor cells growth in vitro, modulate T-cell response to checkpoint inhibitors, reduce carcinogenic inflammation, inhibit tumor cell invasion and migration, suppress histone deacetylase activity, and induce apoptosis
Cancer Clinical Needs and Challenges
There is a need for improved cancer therapies (including therapies for oral cancer), especially for solid tumors where conventional therapies often fail under conditions such as poorly vascularized tumors with inadequate blood perfusion, hypoxia, nutritional deprivation, tumor interstitial pressure, immature lymphatic system, immunosuppressive microenvironment, tumor dormancy, distant tumor metastasis, slowly dividing cells resistant to treatment, or islands of microinvasive tumor cells buried within normal tissues and drug resistance. In addition, it is important to develop new cancer immunotherapy modalities. Among the most attractive characteristics of microbial agents for anticancer therapies is their capacity for tumor-specific targeting and activation of the immune system. Thus, for example, it may be possible to develop a bacteria-based cancer treatment platform for in situ release of immune checkpoint inhibitors.
Recent research advancements in bacterial anti-cancer activities
Multiple studies have demonstrated that anaerobic microorganisms have the unique ability to grow selectively in hypoxic immunosuppressed areas of solid tumors that often are not accessible to drugs. More recently, an integrated bacterial cancer treatment approach utilizing a single multi-function, bacterial payloads for cancer imaging, activation of the immune system, and tumor cell killing were demonstrated. A white paper on the Challenges and Opportunities of Microbial Anti-Cancer Therapy and Prevention summarizes the potential of microbial therapy and recent research advances. Promising results from these studies and the availability of sophisticated gene-editing technology, offer the prospect of developing new concepts and strategies for the use of microbial therapies to mitigate or solve unmet clinical needs. Other studies have shown that gut microbial metabolites can modify the transcription, epigenetics, and metabolism of host immune cells, which can be utilized to activate the immune system. While recent research demonstrates the potential of microbial-based cancer therapy, more research is needed to realize this potential and to bring novel microbial-based therapies to the clinic especially for conditions where conventional cancer therapies are inadequate
The complex nature of the interactions between the microbe, tumor, and immune system requires multidisciplinary collaboration between microbiologists, cancer researchers, and immunologists with the goal of developing innovative approaches to improve our understanding of this system and utilize it for cancer therapy. This initiative seeks to support studies of tumor-microbe interactions needed to develop new cancer imaging and therapy strategies that address unmet clinical needs. The multi-disciplinary research teams are expected to conduct cutting-edge research aimed at advancing pre-clinical development of novel bacteria-based anticancer therapeutic or diagnostic agents. The goal is to conduct research that could have a major impact on cancer therapy and related research
Multi-disciplinary research teams are expected to conduct cutting-edge research within the scope of the NOFO (see above) aimed at advancing pre-clinical development of novel microbial-based anticancer therapeutic agents, cancer imaging, and diagnostics technologies, or to study the complex biology involved in the interplay of microbe-tumor-immune system interactions. Applicants applying to this NOFO are expected to address both the microbial and the tumor aspects of microbial cancer therapy, the goal is to conduct research that could have a major impact on cancer therapy and related research.
Potential areas of research may include, but are not limited to:
Microbial species with cancer-selective homing to tumors and colonization have the potential to overcome traditional cancer detection and diagnosis limitations, especially for asymptomatic cancers. Microbes are potentially useful for tumor detection and diagnosis and may provide information about the tumor organ site and characteristics, which facilitates cancer staging, management, and treatment
Microbial-based Cancer Detection and Diagnosis Specific Research Areas:
Many facultative or obligate anaerobic bacteria and engineered bacteria are capable of selective homing and penetrating tumors when systemically administered which is potentially useful for tumor in vivo imaging. By using tumor-specific colonization properties of labeled bacteria, it may be possible to enhance the resolution and sensitivity of various in vivo tumor imaging modalities including CT, MRI, PET, SPECT, ultrasound, optical imaging, etc. for tumor margin detection/excision.
Cancer Imaging Specific Research Areas:
Microbial-based cancer therapy may provide new opportunities, because of the relative simplicity of microbial culturing, microbes may have the potential to be self-regenerating cancer therapeutics, the ultimate sustainable cancer treatment for Low and Low Middle Income Countries (LMIC). Examples of the Center for Global Health specific topics of interest may include:
NIDCR support for this initiative includes research and development of bacterial anticancer agents for the treatment of cancers of the oral cavity, oropharynx, and salivary glands. Therefore, in addition to the general areas of research listed above, examples of NIDCR-specific topics include:
Applications that propose the following will not be reviewed:
See Section VIII. Other Information for award authorities and regulations.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
The maximum project period is 2 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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
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.
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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
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.
Number of Applications
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:
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.
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.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Avi Rasooly, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-240-276-6196
Email: [email protected]
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
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.
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.
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.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Specific Aims: Include a brief sub-section "Statement of Potential Impact" describing the expected potential of the proposed approach to transform cancer imaging or therapy and clinical practice. The following questions should be addressed with this statement.
Research Strategy: The Research Strategy should clearly describe or address the following:
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):
All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.
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.
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.
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.
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
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, NIHs 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.
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.
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 NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer 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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.
Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score.
Significance
Innovation
Specific to this NOFO: Evaluate whether the application addresses inadequaciesin conventional cancer imaging or therapies, such as metastatic tumors, poorly vascularized, hypoxic, solid tumors, dormant or slowly dividing cells resistant to current interventions, and islands of microinvasive tumor cells buried within normal tissues and brain tumors.
Approach
Rigor:
Feasibility:
Investigator(s)
Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
Environment
Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
Specific to this NOFO: Evaluate whether the application describes a multidisciplinary team with expertise in microbiology and cancer research.Evaluate whether the team include expertise in relevant fields such as immunology, molecular or cellular cancer biology.
As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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.
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
As applicable, evaluate the full application as now presented.
As applicable, evaluate the progress made in the last funding period.
As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.
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.
For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
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 be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicants federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicants integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
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 recipients 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 NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
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 NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
Not Applicable
Consistent with the 2023 NIH 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 NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
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 NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
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 NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH 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.
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)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Avi Rasooly, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-240-276-6196
Email: [email protected]
(Cancer Therapy Applications)
Phil Daschner, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6227
Email: [email protected]
(Cancer biology and basic research)
Luis Alejandro Salicrup, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5799
Email: [email protected]
(Global Health)
Miguel Ossandon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5714
Email: [email protected]
(Microbial Based Cancer Diagnostics)
Yisong Wang, Ph.D.
National Cancer Institute (NCI)
Telephone: [email protected]
Email:240-620-0690
(Microbial based Cancer Imaging)
Zhong Chen, MD, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-529-7083
Email: [email protected]
(Microbial based oral cancer Therapy)
Zhong Chen, MD, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 3015297083
E-mail: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
E-mail: [email protected]
Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: [email protected]
Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.