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Grant Analysis

Purpose & Target

- This grant, 'Innovative Research in Cancer Nanotechnology (IRCN)', aims to expand the fundamental understanding of how nanotechnology can be used in cancer research and oncology. It specifically seeks to generate new foundational knowledge for developing nanotechnology-based solutions to significant problems in cancer biology and/or oncology. - Target recipients are diverse organizations capable of conducting in-depth mechanistic studies in cancer nanotechnology, including academic institutions, non-profits, for-profits (including small businesses), and government entities. - This is a SECTOR-SPECIFIC grant, focusing exclusively on cancer research and nanotechnology. - Geographic scope is limited to US-based organizations. While foreign components of US organizations may be involved, the primary applicant must be a US entity. - Key filtering criteria include a strict exclusion of clinical trials, a focus on mechanistic studies, and the requirement that the functional components of proposed nanotechnology be 300 nm or less in dimension. Projects must address overcoming major barriers in cancer biology/oncology. - This grant is a reissue of previous funding opportunities (PAR-23-246, PAR-17-240, PAR-20-284), indicating it is a recurring program, though specific frequency is not fixed.

Financial Structure

Application budgets are limited to $475,000 in direct costs per year.
The maximum project period for the grant is 5 years.
This grant does not require cost sharing or matching funds.
Eligible costs must reflect the actual needs of the proposed project and adhere to NIH grants policies.
Ineligible costs include activities related to clinical trials or in vivo studies in human subjects.
Financial reporting requirements include:
- Annual Research Performance Progress Report (RPPR).
- Regular financial statements.
- Final RPPR, an invention statement, and expenditure data for closeout of the award.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status, other than Institutions of Higher Education)
For-Profit Organizations (Small Businesses, Other than Small Businesses)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized or Other))
Federal Governments (Eligible Agencies of the Federal Government)
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.

Geographic Requirements

Applicant organizations must be based in the United States.
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.

Registration and Compliance

Applicant organizations must register and maintain active status with:
- System for Award Management (SAM) (requires annual renewal).
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations registering in SAM).
- Unique Entity Identifier (UEI) (obtained via SAM.gov registration).
- eRA Commons (organization must identify at least one Signing Official and one Program Director/Principal Investigator).
- Grants.gov (requires active SAM registration).
All Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account.

Project Scope Limitations

Projects proposing Clinical Trials are Not Allowed.
The functional or active component(s) of devices or base materials, whether fabricated, assembled, or synthesized, must be at dimensions of 300 nm or less.
Materials used and/or proposed must be either synthetic or biologically-based, engineered to provide novel properties or modified functions due to controlled assembly or synthesis at the nanoscale.
Non-responsive activities (will not be reviewed) include:
- 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.

Cost Sharing

Not required.

Application Process

Application Submission and Deadlines

Open Date (Earliest Submission Date): April 05, 2025
Application Due Dates (New, Renewal/Resubmission/Revision):
- May 05, 2025
- November 03, 2025
- May 04, 2026 (Latest deadline)
All applications are due by 5:00 PM local time of the applicant organization on the due date.
If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.
Applicants are encouraged to submit early to allow time for corrections.

Submission Process

Applications must be submitted electronically through one of the following systems:
- NIH ASSIST system.
- Institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Applicants must track the status of their application in the eRA Commons.
Applications that are incomplete, non-compliant, or non-responsive will not be reviewed.

Required Documentation and Materials

Standard application forms (SF424(R&R) series).
Research Plan (PHS 398) including:
- Specific Aims.
- Research Strategy (Significance, Investigator(s), Innovation, Approach, Environment, and a mandatory 'Milestones' subsection).
Resource Sharing Plan.
Data Management and Sharing Plan (required for all applications generating scientific data).
Limited Appendix materials (only blank questionnaires or surveys are allowed; no publications).
PHS Human Subjects and Clinical Trials Information form (if human subjects research is involved, but not for clinical trials).

Review and Award Timeline (for May 04, 2026 submission)

Scientific Merit Review: November 2026
Advisory Council Review: January 2027
Earliest Start Date: April 2027

Post-Award Requirements

Annual Research Performance Progress Report (RPPR) and financial statements.
Compliance with all terms and conditions outlined in the NIH Grants Policy Statement.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval, if applicable.
Implementation of the approved Data Management and Sharing Plan.
Submission of a final RPPR, invention statement, and expenditure data for closeout.

Application Assistance

eRA Service Desk: For system questions (ASSIST, eRA Commons, errors, submission issues).
General Grants Information: For application instructions and processes.
Grants.gov Customer Support: For registration and Workspace issues.
Scientific/Research Contact(s): For program-specific scientific questions.
Peer Review Contact(s): Available through eRA Commons after review assignment.
Financial/Grants Management Contact(s): For budget and award administration questions.

Evaluation Criteria

The evaluation emphasizes basic or pre-clinical research projects with high potential to generate significant new knowledge relevant to the fundamental understanding of in vivo and in vitro processes in cancer nanotechnology. Overall Impact

Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the research field.

Scored Review Criteria

Factor 1. Importance of the Research (Significance and Innovation):
- Project scope must emphasize fundamental understanding of mechanisms in cancer nanotechnology.
- Rationale for producing significant fundamental, mechanistic knowledge relevant to improving cancer therapeutic/diagnostic approaches.
- Comparison of the proposed nanotechnology solution to available classical approaches or current nanotechnology solutions, detailing how it overcomes limitations (supported by preliminary or literature data).
- Identification of key advantages and innovative aspects.
Factor 2. Rigor and Feasibility (Approach):
- Projects should be conceptually well-developed and supported by appropriate preliminary data.
- Description of planned interactions with NCI's Nanotechnology Characterization Laboratory (NCL).
- Commitment to deposit data into the cancer Nanotechnology Laboratory data portal (caNanoLab).
- Rationale for selection of one or two tumor types, considering benefits from nanotechnology and available molecular genetics resources (e.g., TCGA, TARGET, CGCI).
- Description of planned animal tumor models.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Investigator(s): Demonstrated background, training, and expertise suitable for the proposed work. For multiple Principal Investigators, the quality of the leadership plan is assessed.
- Environment: Institutional resources must be appropriate for successful project execution.
Milestones:
- Comprehensiveness and realism of discrete benchmarks.
- Ability of milestones to provide accurate and informative evaluation of annual progress.
- Adequacy of alternative approaches or contingencies.

Additional Review Criteria (considered, but not scored)

Protections for Human Subjects (if applicable): Justification for involvement, proposed protections, potential benefits, importance of knowledge, data and safety monitoring.
Vertebrate Animals (if applicable): Description of procedures, justifications for use, interventions to minimize discomfort, and justification for euthanasia method.
Biohazards (if applicable): Assessment of hazardous materials/procedures and proposed protection.
Resubmissions: Evaluation of the full application as presented.
Budget and Period of Support: Justification and reasonableness of the budget and requested project duration in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Awards are subject to 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, Audit Requirements for Federal Awards).
All NIH grant awards include the NIH Grants Policy Statement as part of their terms and conditions.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance, including public policy requirements.
Mandatory disclosure of any violations of federal criminal law (fraud, bribery, gratuity) potentially affecting the federal award.

Data Management and Sharing

Applicants are required to comply with the 2023 NIH Policy for Data Management and Sharing.
Investigators are required to deposit their data into the cancer Nanotechnology Laboratory data portal (caNanoLab).

Technical and Scope Requirements

Proposed nanotechnology approaches, materials, or devices must have functional components at dimensions of 300 nm or less.
Materials must be specifically engineered (synthetic or biologically-based) for novel properties or modified functions at the nanoscale, not only naturally-occurring materials.
Projects must focus on mechanistic studies to expand fundamental understanding of nanomaterial/nano-device interactions with biological systems.
Clinical trials or in vivo studies in human subjects are strictly excluded.
Research focused on nanotechnology for AIDS/HIV is out of scope.

Ethical Standards

Projects involving human subjects or vertebrate animals must adhere to specific NIH guidelines for protection and ethical review.
Research involving biohazards must ensure adequate protection for personnel and the environment.

Intellectual Property

An invention statement is required for award closeout, implying that any intellectual property generated must be reported.

Strategic Alignment and Resources

Investigators are strongly encouraged to attend an annual NCI meeting for nanotechnology program investigators.
Interaction with NCI's Nanotechnology Characterization Laboratory (NCL) is strongly encouraged for nanomaterial characterization.
Applicants are encouraged to leverage NCI-supported animal models (e.g., Laboratory Animal Science Program (LASP), Center for Advanced Preclinical Research (CAPR)).
When selecting tumor types, applicants are encouraged to use available resources with catalogs of comprehensively characterized clinical tumors (e.g., The Cancer Genome Atlas (TCGA), Therapeutically Applicable Research to Generate Effective Treatments (TARGET), Cancer Genome Characterization Initiative (CGCI)).

Grant Details