RFA-CA-27-001-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

Early-Stage Innovative Technology Development for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed)

Activity Code

R61 Phase 1 Exploratory/Developmental Grant

Announcement Type

Reissue of

RFA-CA-25-001

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-CA-27-001

Companion Funding Opportunity

RFA-CA-27-002

, R33 Exploratory/Developmental Grants Phase II

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.394

Funding Opportunity Purpose

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits grant applications proposing to develop innovative technologies offering new capabilities for the molecular or cellular characterization of cancer or for improved handling and quality control of biospecimens for basic, clinical, or epidemiological cancer research. The NOFO solicits R61 applications for early-stage projects proposing proof-of-concept/pilot studies to test the technical feasibility of the proposed method, tool, assay, platform, or instrument. Technologies proposed for development may have potential for widespread applicability but must be focused for this program on cancer-relevant use cases. Projects proposing to apply or use existing technologies for hypothesis-driven research where the novelty resides in the biological or clinical target/question being pursued are not responsive to this solicitation and will not be reviewed.

This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

Funding Opportunity Goal(s)

The goals of this NOFO are to improve screening and early detection strategies and to develop accurate diagnostic techniques and methods for predicting the course of disease in cancer patients.

Key Dates

Posted Date

June 03, 2026

Open Date (Earliest Submission Date)

June 10, 2026

July 10, 2026

July 10, 2026

Not Applicable

April 2027

November 10, 2026

November 10, 2026

Not Applicable

July 2027

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.

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

Due Dates for E.O. 12372

Not Applicable

Expiration Date

November 11, 2026

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

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), the National Cancer Institute (NCI) solicits grant applications proposing exploratory research projects focused on the inception and early-stage development of highly innovative technologies with new or improved capabilities for targeting, probing, or assessing molecular and cellular features of cancer biology or for handling or performing quality control of biospecimens for basic or clinical cancer research. This NOFO is meant to support highly innovative projects with high potential impact in a cancer-relevant field, even if they involve some level of risk of failure. Technologies proposed for development may have the potential for widespread applicability but for this program, projects must focus on improving cancer-relevant technical capabilities.

This NOFO utilizes the R61 award mechanism for exploratory/developmental projects. The R61 mechanism is suitable for projects that are at their inception, conceptual, or idea-based phase. In this phase, the technical feasibility of the proposed technology or methodology should not yet have been established. Preliminary data are not required but are accepted if available. If preliminary data are sufficient to suggest the feasibility of the approach is established, then consideration should be given to submitting to the companion R33 NOFO (RFA-CA-27-002).

Applications involving further improvements to an existing technology that has not yet been demonstrated for the proposed cancer-relevant application(s) are also within the scope of this NOFO but must involve significant additional technical modifications/development for the proposed cancer-relevant context of use, or some significant question of feasibility exists for achieving the proposed technical performance. A clear description of the feasibility risk for the proposed advancement of that technology must be included in the application to justify the use of the R61 mechanism. Applicants are encouraged to reach out to the Scientific/Research Contact below with any questions.

This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

The IMAT Program Since its inception in 1998, the IMAT Program has focused on stimulating and accelerating the development, validation, maturation, and dissemination of the most novel and highly innovative technologies in support of cancer research and medicine. Together with the NCI's other technology-focused programs, the IMAT program continues to support the development of tools and methods that enable cancer researchers to make new discoveries, enhance our understanding of cancer etiology and proliferation, improve detection capabilities, develop diagnostic methods and treatment strategies, conduct population-scale studies, and assist in clinical decision-making.

The current issuance of the IMAT Program consists of two separate NOFOs that cover the following two stages of development:

Additional information about the IMAT Program and its individual NOFOs can be found on the IMAT website.

Specific Research Objectives and Scope of this NOFO The proposed projects must be focused on early-stage development and proof-of-concept of an innovative molecular or cellular analysis technology or tool for biospecimen handling/quality control. In addition, all projects proposed in response to this NOFO must involve all the following general attributes:

For details on addressing these requirements, see Section IV. Application and Submission Information.

Responsive Technologies and Scientific Scope Responsive technologies include relevant novel materials, platforms, assays, instrumentation, devices, and associated methods. These technologies may be intended for use in vitro, in situ, and/or in vivo (with some exceptions listed below), and may target the needs of basic, diagnostic, translational, epidemiological, and/or clinical cancer research. This program specifically supports new molecular/cellular analysis technologies (e.g. sequencing approaches, proteomics methods, imaging technologies, immuno oncology tools, biomarker detection assays, etc.) as well as novel biospecimen science tools (e.g. new approaches for the collection, isolation, handling, storage, or quality assessment of cancer biospecimens including tissue, blood, cultured cells, model systems, etc.). The proposed projects must clearly be focused on the development of generally applicable technologies to advance cancer research, NOT on pursuing specific discoveries with these tools. Applications focused on using technologies for hypothesis-driven research and not on building new technical capabilities will be considered nonresponsive and will not be reviewed.

Technology development projects in any area of cancer-related research are encouraged. General areas of interest include, but are not limited to, the following:

Applications must include quantitative performance measures. Performance measures are a means of judging the success of the project and technical function of the proposed technology (device, assay, etc.). Performance measures should be well-described, quantifiable, and scientifically justified. Critical components for proposed measures include the numerically described target of performance as well as the means by which it will be assessed. For additional details on this requirement, see Section IV. Application and Submission Information.

Non-Responsive Projects The following aspects/characteristics remain outside the scope of the IMAT Program and this NOFO. Applications proposing projects with any of the following characteristics will not be reviewed:

As there are several unique review considerations for this NOFO, applicants must address the requested items outlined for the Research Plan in Section IV. Application and Submission Information.

IMPORTANT NOTE: Researchers uncertain as to whether their intended technology development project meets the requirements of this NOFO are encouraged to contact the Scientific/Research Contact listed below.

Alternative Opportunities Related IMAT NOFO: Applicants proposing projects that are beyond questions of technical feasibility, but still require further development and validation should consider applying to the companion NOFO (RFA-CA-27-002), which uses the R33 mechanism. Further development encompasses optimization and scaling of the technology or merging with complementary technologies to improve the overall functionality. NOTE: Applications proposing to use novel technologies for hypothesis-driven research or merge complementary technologies without a substantial requirement for further development or a clear need for technical/analytical validation are beyond the scope of the IMAT program solicitations altogether.

Other technology-related funding opportunities. Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software development solutions should consider one of the Informatics Technologies for Cancer Research (ITCR) opportunities. Researchers who emphasize the assessment of whole-body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP) for information on additional funding opportunities. Technologies that are beyond the early development stages supported by this program and are ready for use in hypothesis-driven research, clinical validation, or translation/commercialization should consider the many other programs at NCI that support these projects.

Annual Meeting An annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the development of technologies for cancer research and clinical care for cancer patients. All investigators supported through this NOFO are required to attend this meeting each year, lasting 2-3 days, unless otherwise notified by NCI program officials.

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

Resubmission

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.

Clinical Trial?

Not Allowed: This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI intends to commit a total of $5,100,000, in fiscal year 2027 to fund an estimated 20 awards. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $150,000 per year (direct costs).

Award Project Period

The total project period request may not exceed 3 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

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)

Foreign Organizations/International Collaborations

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.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

For this specific NOFO, the Research Strategy section is limited to 6 pages.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

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

SF424(R&R) Senior/Key Person Profile

R&R Budget

For this specific NOFO, a modular budget is expected unless the applicant is a Foreign Organization.

Travel: Applicants may include travel support for an investigator from their research team to attend the IMAT Program annual meeting. The meeting location varies each year and is held at an IMAT investigator institution site in the U.S. or at NIH's facilities in Maryland. All investigators supported through this NOFO must attend this meeting annually.

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy: Applicants may organize their research strategy as desired, but must address the following required aspects:

Importance of Research

Rigor and Feasibility Describe the technical approach, including steps to develop the proposed technology. A clear description of the feasibility risk for the proposed advancement of the technology should be included in the application to justify the use of the R61 mechanism, as well as how this risk can be mitigated by identifying anticipated difficulties and describing possible workarounds.

Quantitative Performance Measures

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:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

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

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

Foreign Organizations Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply – Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

Prior Consultation with NCI Consultation with NCI staff at least 5 weeks prior to submitting the application is strongly encouraged for submission of a new R61 application. If requested, NCI staff will consider whether the proposed aims of the technology development project are within the scope of the funding opportunity and whether the proposed performance measures meet the minimal requirements of the NOFO. NCI staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this NOFO. During the consultation phase, if the proposed project is not in scope for this program, applicants will be strongly encouraged to consider other Funding Opportunities. To consult with NCI staff, send an email to the scientific contact listed at the end of this NOFO; include the funding opportunity number in the subject line to ensure your inquiry is routed correctly.

Mandatory Disclosure

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 grantdisclosures@oig.hhs.gov.

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 R61 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical research. An R61 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R61 applications; however, they may be included if available.

Overall Impact

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.

Scored Review Criteria

Reviewers will consider 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 factor score.

Factor 1. Importance of the Research (Significance and Innovation)

Innovation

Specific to this NOFO:

Evaluate the level of technical innovation and exceptional creativity in the proposed technological advancements.

Evaluate the superiority of the proposed technology in terms of the new or improved capabilities it will offer relative to current methods.

Evaluate the potential of the proposed technology to enable future discoveries in cancer research and/or improve clinical care and whether it could be transformative in its intended use case if successfully developed.

Factor 2. Rigor and Feasibility (Approach)

Rigor:

For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

Factor 3. Expertise and Resources (Investigator(s) and Environment)

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.

Additional Review Criteria

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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.

This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

As applicable, evaluate the full application as now presented.

Renewals

As applicable, evaluate the progress made in the last funding period.

Revisions

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations

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.

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

Performance Measures

Assess whether the proposed performance measures are quantitative, reasonable, and if achieved would be adequate to establish proof-of-concept for the technology to serve as a foundation for the next phase of developmental efforts. Evaluate how appropriate the measures are to determine whether the aims of the project have been accomplished and whether key risk factors for the project have been addressed. Describe whether meeting these proposed performance capabilities would establish a useful tool that the research community would be likely to benefit from.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO.