Part 1. Overview Information

Key Dates

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.

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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

Purpose

Through this Notice of Funding Opportunity (NOFO) entitled "Innovative Research in Cancer Nanotechnology (IRCN)", the National Cancer Institute (NCI) intends to expand the fundamental understanding of the processes pertinent to the use of nanotechnology in cancer. The goal of IRCN projects is to conduct mechanistic studies and generate new fundamental knowledge associated with the development of nanotechnology-based solutions to major problems in cancer biology and/or oncology. IRCN awards are expected to produce fundamental knowledge to aid future and more informed development of practical nanotechnology-based cancer interventions (although prospective clinical translation of the IRCN findings remains beyond the scope of this NOFO). Projects supported by the IRCN initiative will incorporate multi-disciplinary research in biology/oncology, chemistry, physics, and/or engineering.

Nanotechnology in the context of this NOFO. To be responsive to this NOFO, the proposed nanotechnology approaches, materials, devices, and technologies should meet the following criteria:

• The functional or active component(s) of devices or base materials either fabricated, assembled, or synthesized, must be at dimensions of 300 nm or less;
• Materials used and/or proposed to be developed must be either synthetic or biologically-based materials that are engineered to provide novel properties or modified functions due to their controlled assembly or synthesis at the nanoscale.

Background

Potential of nanotechnology in cancer research and oncology. Significant progress has been made in the synthesis and characterization of engineered nanoparticles and nano-devices for diagnosis and treatment of cancers with few cancer nanotechnology strategies already moving into clinical trials and obtaining FDA approval. However, these strategies produced only modest improvement in treatment efficacy, survival rates, and/or early diagnosis capabilities. In order to improve the effectiveness of nanotechnology-based cancer interventions and gain their broader acceptance, further systematic and mechanistic studies on a fundamental understanding of nanomaterial and/or nano-device interactions with biological systems are needed.

NCI has been supporting the development of nanotechnology for cancer prevention, diagnosis, and treatment using a wide range of funding mechanisms (http://nano.cancer.gov). The information on general areas of research interest and status of these activities can be found in the following documents:

• Strategic Workshop on Cancer Nanotechnology held at NCI (the workshop's report can be found at https://www.ncbi.nlm.nih.gov/pubmed/31240914); and
• Summary of outcomes of the NCI Alliance for Nanotechnology in Cancer program (publication can be found at https://www.ncbi.nlm.nih.gov/pubmed/31257722).

Research Objectives for IRCN

General Expectations for IRCN Projects. IRCN projects are expected to advance employment of nanotechnology in understanding, diagnosing, and treating cancer. Each proposed IRCN project is expected to generate new fundamental knowledge aiding the development of nanotechnology-based solutions to major problems in cancer biology and/or oncology. Typical efforts and applications in this area of research involve 1) demonstration of cancer therapies based on nanoparticles with the attempt to obtain improved efficacy and 2) demonstration of diagnostic tools (in vitro or in vivo) with improved sensitivity and specificity. These are clear and known objectives, but it is often that the above goals are pursued without a full understanding of the therapeutic mode of action or insight into mechanisms contributing to improved sensitivity and specificity of diagnostics. Projects submitted to this NOFO need to be designed differently. While proposing an innovative, nanotechnology-based solution to cancer biology and/or oncology problems, the project should focus on mechanistic studies. These studies are expected to address the fundamental understanding of nanomaterial and/or nano-device interactions with biological systems in the effort to uncover mechanisms governing effective delivery and therapeutic and/or diagnostic action of nanoparticles and/or nano-devices at desired and intended cancer targets in vivo and/or successful operation of detection and diagnostic devices and sensors in vitro. The innovative use of nanotechnology to solve cancer biology/oncology problems is viewed as more significant than innovation in nanotechnology itself (e.g., development of new nanomaterials).

Possible Research Directions. Examples of appropriate research areas are listed below. These examples are not meant to be comprehensive. Additional research foci are also encouraged, provided they are consistent with the general expectations stated above.

• Understanding nanoparticle delivery mechanisms and implications of systemic distribution;
• Understanding intracellular trafficking of nanoparticles;
• Increasing understanding and refinement of next-generation nanosystem designs;
• Designing nanoparticles with reconfigurable properties enabling conditional activation of therapeutic function;
• Designing strategies for alternate routes of therapeutic delivery (e.g. oral, intranasal, transdermal);
• Tools to interrogate and understand cell signaling resulting from tumor progression and/or its treatment;
• Techniques and tools to overcome the failure of therapy and therapeutic resistance;
• Tools and devices aimed specifically at monitoring and understanding the tumor microenvironment;
• Technologies for cancer molecular targeting and discovery;
• Devices and tools capable of penetrating cellular and/or physiological barriers;
• Tools for high throughput screening of drug candidates;
• Tools for improved effectiveness of cancer immunotherapies;
• Tools to understand and minimize immune-related adverse effects (irAEs) of cancer immunotherapies;
• Leveraging lipid nanoparticles know-how from COVID vaccine development to designing mRNA-based cancer therapies;
• Development of approaches for effective delivery of nucleic acid therapies;
• Development and understanding of nanoparticle-based radiation therapies and dosimetry;
• Development of improved multi-biomarker detection elucidating previously unknown cancer biology and based on diagnostic devices and sensors;
• Design of sensitive and specific imaging agents and theranostics;
• Integration of modeling and simulation approaches to guide rational nanomaterial design; 
• Use of artificial intelligence (AI) and modeling to aid rational drug design.

Tumor Types. All IRCN applicants are expected to concentrate their proposed efforts on one or two rationally selected tumor types. For this NOFO, a "tumor type" refers to either tumors of a specific tissue of origin or tumors with critical abnormalities in a particular molecular pathway(s) shared in cancers arising from a variety of tissues.

Annual Principal Investigators' Meeting

NCI holds an annual meeting of investigators funded through the institute's nanotechnology programs with the purpose of sharing research progress and establishing collaborations. All investigators supported by this NOFO are strongly encouraged to attend this two-day meeting organized by NCI each year.

Non-responsive Applications

The following types of activities remain outside the scope of this NOFO, and applications proposing such activities are non-responsive to this NOFO and will not be reviewed.

• Proposing only the use of naturally-occurring materials (e.g., polysaccharides, proteins, viruses) that are not specifically engineered or modified for the intended function;
• Involving clinical trials or in vivo studies in human subjects;
• Focusing on nanotechnology solutions for AIDS/HIV, even in the context of cancer.

Additional Available Resources

Applicants are encouraged to consider using, as appropriate, various relevant NCI-supported resources described below. Pls contact these resources for exact rules/conditions to utilize them.

• Nanomaterials characterization. The NCI recognizes that further development of nanotechnologies for oncology purposes will benefit greatly from a concerted and coordinated effort to characterize the wide range of nanoscale materials and devices. The NCI’s Nanotechnology Characterization Laboratory (NCL; http://ncl.cancer.gov/ ) provides infrastructure support towards the uniform and consolidated characterization of these materials and devices and aids the translation of nanotechnology-derived cancer therapeutics and diagnostics.
• Nanotechnology-related informatics. The NCI Center for Biomedical Informatics and Information Technology (CBIIT; https://datascience.cancer.gov/ )  sponsors the cancer Nanotechnology Laboratory data portal (caNanoLab; https://cananolab.nci.nih.gov/caNanoLab/ ) caNanoLab is designed to facilitate the sharing of nanomaterials data and to expedite and validate the use of nanomaterials in medicine.
• Animal models. NCI supports a broad spectrum of animal facility experimental resources under the Laboratory Animal Science Program (LASP; https://ncifrederick.cancer.gov/lasp/ ). It also operates the Center for Advanced Preclinical Research (CAPR; https://ccr.cancer.gov/capr ) that can conduct an independent preclinical assessment of nanomaterials in vivo in a variety of predictive xenograft and genetically engineered mouse models, as well as syngeneic genetically engineered mouse-derived allografts.

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

Section II. Award Information

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

1. Eligible Applicants

Higher Education Institutions

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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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 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.

• 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. 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.

2. Cost Sharing

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

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:

• 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.

Page Limitations

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.

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:

Specific Aims: Outline the specific goals of the project.

Research Strategy: The proposed project description must consist of the standard subsections: Significance, Investigator(s), Innovation, Approach, Environment, and an additional "Milestones" subsection (described below).

Significance

Project Scope and Emphasis. The proposed project should emphasize fundamental understanding of mechanisms associated with the use of nanotechnology in solving a cancer-relevant problem. Provide rationale for why the proposed project is expected to produce a significant body of fundamental, mechanistic knowledge relevant to the improvement of cancer therapeutic and/or diagnostic approaches based on nanotechnology.  

Innovation

In the Innovation sub-section, provide a comparison of the proposed nanotechnology-based solution of cancer-relevant problem to available or possible classical approaches/options and/or currently used nanotechnology solutions. Discuss how the problem is approached at present and the limitations of current solutions, and how the proposed nanotechnology is expected to overcome these limitations. Summarize the key advantages and innovative aspects of the proposed technology and solution over other options. This comparison should be based on actual data (either investigators’ own preliminary data or literature data).

Approach

In the Approach subsection, provide information pertaining to the following requirements.

1. Well Developed, Rigorous Project. Proposed projects are expected to be well developed conceptually and, in general, well supported by appropriate preliminary data from investigators’ laboratories.

2. Interaction with the NCI's Nanotechnology Characterization Laboratory (NCL; http://ncl.cancer.gov/ ) is strongly encouraged during the course of the project. Please describe the areas of nanomaterial characterization, you intend to work with NCL on. 

3. Data sharing. NCI supports the cancer Nanotechnology Laboratory data portal (caNanoLab; https://cananolab.nci.nih.gov/caNanoLab/)/ The investigators are required to deposit their data into caNanoLab. These data submission requirements are in line with the current NCI data management and (DMS) sharing policy. 

4. Selection of Tumor Types. The project may focus, as appropriate and justified, on one or two rationally selected tumor types or types of abnormalities. In selecting specific tumor types, IRCN applicants are strongly encouraged to consider cancers that may strongly benefit from a nanotechnology approach and to take advantage of available resources with catalogs of clinical tumors that have been comprehensively characterized at the molecular genetics level (e.g., by programs such as The Cancer Genome Atlas (TCGA), http://cancergenome.nih.gov/, Therapeutically Applicable Research to Generate Effective Treatments (TARGET), http://ocg.cancer.gov/programs/target, and Cancer Genome Characterization Initiative (CGCI), http://ocg.cancer.gov/programs/cgci). Additionally, applicants should consider the tumor type relative to its existing treatment and/or diagnostic paradigms and how their proposed approach could improve these for the tumor type or respective indication.

5. Selection of Animal Tumor Models. Describe the animal tumor models that you plan to use in the proposed studies.

6. Possible Research Directions. Examples of appropriate research directions are listed in Section I. The list is not meant to be comprehensive and additional directions/topics are also encouraged, providing they fit into the overall goals of IRCN funding opportunity and conform to other requirements. Moreover, the listed examples are NOT mutually exclusive and are NOT meant to confine the scope of a project. Various directions may be combined into a single project, if appropriate.

Milestones

This subsection is required for all applications. All applicants must describe here a set of discrete benchmarks that will allow unequivocal determination of the progress over time made towards the goals of the project. Milestones should be scientifically justified and well-defined for each year of the project and be based on the proposed specific aims. Whenever feasible, milestones should provide quantitative benchmarks for comprehensively assessing the annual progress of the project. Milestones must not be simply a restatement of the specific aims. The specific aims describe the research goals of the project. The milestones should provide the means for assessing the progress made towards each aim and offer a timeline for it. The completion of these milestones will be used to judge the success of the proposed research on an individual-project basis.

Examples of Milestones:

• Verify that designed composite nanoparticles are capable of reproducible release of its "cargo" at tumor/cancer cell sites in vivo.
• Ascertain that a new targeted nanoparticle can specifically deliver a therapeutic agent to the tumor by demonstrating “x” times improvement as compared to "free" drug delivery.
• Demonstrate the ability of a nanoparticle diagnostic construct to detect at least “x” specific proteins in blood (out of “y” specific proteins proposed) at a femtomolar level.
• Demonstrate the ability of the proposed nanotechnology to achieve 95% rate of capture for circulating tumor cells in blood.

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:

• 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.

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, 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.

6. Funding Restrictions

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 organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide.

See more tips for avoiding common errors.

 Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NCI, 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].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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 NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The emphasis and priority of this NOFO are on the development of basic or pre-clinical research projects, addressing major barriers in cancer biology and/or oncology using nanotechnology-based solutions. The priority is placed on innovative projects with high potential to generate significant new knowledge relevant to a fundamental understanding of in vivo and in vitro processes pertinent to the use of nanotechnology in cancer research and care.

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. 

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.

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.

2. Review and Selection Process

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:

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

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 applicant’s 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 applicant’s 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.

3. Anticipated Announcement and Award Dates

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.

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 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.

2. Administrative and National Policy Requirements

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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.

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 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.

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)

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]

Piotr Grodzinski, Ph.D.
National Cancer Institute (NCI)
Telephone 240-781-3305
Email: [email protected]

Leela Rani Avula, Ph.D.
National Cancer Institute (NCI)
Telephone 240-276-5164
Email: [email protected]
 

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]
 

Section VIII. Other Information

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.