NEI Research for Low Vision and Blindness Accessibility Tools (R61/R33 Clinical Trial Optional)

NEI Research for Low Vision and Blindness Accessibility Tools (R61/R33 Clinical Trial Optional) is sponsored by National Eye Institute (NEI), National Institutes of Health (NIH). This Notice of Funding Opportunity (NOFO) stimulates translational efforts in developing and implementing accessibility devices or interventions that apply new technologies to address challenges faced by individuals living with visual impairment.

Expired RFA-EY-24-003: NEI Research for Low Vision and Blindness Accessibility Tools (R61/R33 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Eye Institute ( NEI ) Funding Opportunity Title NEI Research for Low Vision and Blindness Accessibility Tools (R61/R33 Clinical Trial Optional) R61 / R33 Exploratory/Developmental Phased Award August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to stimulate translational efforts in developing and implementing accessibility devices or interventions that apply new technologies to address challenges faced by individuals living with visual impairment.

Critical elements of applications include a clear set of milestones that support development and testing of the tool, device, or intervention proposed; multidisciplinary and collaborative teams that include individuals with lived experience; and a tractable dissemination plan.

The overall goal of the program is to push the boundaries of innovation in technology development to address accessibility needs of individuals with visual impairment and create resources that will be made available to the community. This NOFO uses a milestone driven and phased mechanism of award.

Initial technology development and feasibility activities (R61 phase) may transition to expanded research support (R33 phase) for validation, larger-scale feasibility, and effectiveness studies. All applications must address both R61 and R33 phases.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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 How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information 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 Despite medical advances made in treating and preventing blinding diseases and disorders, many remain incurable and result in impaired vision for approximately seven million Americans.

According to the CDC , approximately one million Americans are blind and six million live with low vision, an impairment that is not correctable with surgery, glasses, or contact lenses and hampers one's ability to function in daily life. These individuals face myriad challenges in performing activities of daily living, ensuring basic health maintenance, and pursuing educational and employment opportunities.

Historically, these challenges have been addressed through Accessibility or Universal Design efforts for the visually impaired (i.e., the development of tools to support productivity and quality of life for people affected by visual impairment). Many well-established accessibility products exist (e.g., Braille, magnifiers) and many are evolving as new technologies come online (e.g., Smartphone text-to-speech software).

The unprecedented innovating and growth of new technologies provides an opportunity to transform accessibility efforts. Research Objectives and Scope The main objective of this funding opportunity is to harness advances in technology development to innovate accessibility tools for individuals with visual impairment.

The projects will be "translation science" driven, with quantifiable milestones and timelines identified, potentially refined, and evaluated on an ongoing basis. The proposed research is divided into two phases as appropriate, with the milestone driven R61 phase demonstrating initial feasibility of the technology or tool followed by further validation, feasibility, and/or effectiveness studies in the R33 phase.

Adjustment of project aims and budgets by the NEI may be required based on the progress of the project toward meeting its milestones. Projects proposed under this initiative must include: Investigative teams with transdisciplinary expertise , bringing together complementary areas that will inform the tool development, use, and dissemination.

Potential areas could include (but are not limited to) engineering, computer science, behavioral and social science, robotics, psychophysics, ergonomics/human factors, rehabilitation science, and universal design. Proposed teams must demonstrate technical and intellectual synergy and a collaboration strategy must be outlined in the application. Individuals with lived experience must be engaged in all stages of the project.

Plans for their involvement must be highlighted and submitted as an "Other Project Information" attachment (see Section IV further below). Plans driven to serve the goals and needs of the user . User-centered design should be applied early in the tool development, with user-centered and universal-design milestones incorporated into the Research Plan.

Tools must address and translate to real-world challenges. A clearly articulated dissemination plan for the resultant tool that addresses timeframe, expanded access (for individuals, communities, business providers, public facilities), affordability, and process for evaluating success of the dissemination effort.

Specific Areas of Research Interest The objective of this initiative is to push the boundaries of innovation in technology development to address accessibility needs of individuals with visual impairment.

Examples of opportunities include (but are not limited to): Integrate 3D-motion sensing and software engineering to design mobile app wayfinding solutions for complex environments Enhance keyboard versatility and accessibility via newly engineered materials, wearable designs, or voice-powered technology Apply artificial intelligence and machine learning to advance screen reader technology, optimize object recognition, relay dynamic digital content, or improve alt text descriptions Combine 3D imaging and printing in map development, tactile graphical and diagram displays, or instructional materials for Science, Technology, Engineering and Mathematics (STEM) Incorporate multisensory displays (sonification, haptic, tactile) in virtual reality systems to convey visual information Engineer advances in smart braille devices (e.g., multi-line refreshable braille displays) Applications Not Responsive to this NOFO The following types of applications will be considered non-responsive to this NOFO and will not be reviewed: Applications proposing minor enhancements to existing devices/tools Applications that cannot be tested in a translational setting Applications that do not provide a collaboration strategy for the research team and do not engage individuals with lived experience Applications that do not include specific milestones for transition from R61 to R33 phase Applications that do not have a dissemination plan addressing accessibility and affordability R61 Phase and Transition to R33 Phase This funding opportunity uses a R61/R33 Phased Innovation Award activity code.

Support will be provided for up to 5 years, which includes initial support of up to 2 years for the R61 phase, followed by up to 3 years of support for the R33 phase upon successful completion of the R61 milestones. The accessibility tool proposed in the R61 phase should be at the inception stage and untested with regard to accessibility design.

Preliminary data are not necessary; the write-up should describe the innovative nature of the particular technology and/or approach proposed for development. Clear aims, measurable objectives, and timelines must be outlined in the proposed milestones.

An administrative review of the extent to which peer-reviewed milestones are met in the R61 phase will determine whether the R33 phase award will be issued, subject to NEI funding availability. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Clinical trials proposed should entail minimal participant risk -- specifically, the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46). See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information 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 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. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NEI intends to commit $5 million (total costs) in FY 2025 to fund 5-8 awards. For the R61 phase, direct costs may not exceed $400,000 per year.

For the R33 phase, direct costs may not exceed $650,000 per year. In all cases, the budget should be reasonable and appropriate for completing the research project. The maximum period of the combined R61 and R33 phases is 5 years, with up to 2 years for the R61 phase and up to 3 years for the R33 phase.

The scope of the proposed project should determine the requested project award period. 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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 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 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. 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.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities , NOT-OD-22-019 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms.

3. Additional Information on Eligibility 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 How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

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. 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. The following additional instructions apply: Plan to Include Lived Experience In an "Other Attachment" entitled "Plan to Include Lived Experience" all applicants must include a 1-page summary of strategies to enhance the proposed project through the involvement of individuals with visual impairment.

The Plan will be considered as part of the scientific and technical peer review evaluation, as well as at the programmatic level with respect to funding decisions. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Specific Aims: Describe and identify with headers the Specific Aims for each of the two phases (R61 and R33) on a single Specific Aims attachment. Research Strategy : The research plan should describe the tool development approach and how it will address accessibility needs of individuals with visual impairment.

The Research Strategy should contain separate sections that describe the R61 and R33 phases. The R61 (Phase 1) should establish the technology and tool development strategies driven by user-centered design. Preliminary data are not required; however, the application may include preliminary data towards study feasibility if they are available.

The Research Strategy for the R33 Phase (Phase 2) should be described in enough detail for reviewers to evaluate the merit of this component based on anticipated results. Outline how the R33 phase of the study will develop and expand once the R61 phase is completed and proposed milestones are met. A clear dissemination plan for the resultant tool must be included.

In preparing the R61/R33 application, investigators should consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the milestones are critical. Applications should include the subsections described below.

Significance - in addition to the SF424 (R&R) Application Guide, include the following: Describe and justify the need and translational opportunities for the new accessibility tool. Potential advantages related to effectiveness, affordability, usability, accessibility, and/or sustainability are also important considerations. A dissemination plan for the resultant tool may include these points.

Investigators - in addition to the SF424 (R&R) Application Guide, include the following: Investigative teams must include transdisciplinary expertise that will cover technological and user-centered tool development and dissemination areas. Expertise must include individuals with lived experience .

The application should delineate the roles of each key personnel, propose a collaboration strategy, and provide plans for the coordination of research activities. Innovation - in addition to the SF424 (R&R) Application Guide, include the following: The application should describe how the proposed tool uses new/emerging technology, platforms, or software that has advantages over existing ones for accessibility targets.

Approach - in addition to the SF424 (R&R) Application Guide, include the following: Overall, clear steps in tool development, assessment, and dissemination should be outlined and incorporate user-centered and/or universal-design methods. Any available preliminary data that will support or justify the proposed research may be included. However, preliminary data are not required for an R61/R33 application.

For the R61 phase, transition milestones and a timeline are required and should be described at the end of the R61 approach section. The major tasks to be completed should be outlined and linked to milestones that are well defined, have tractable metrics of success, and support the projects translational goals. The timeline should identify when specific milestones will be completed.

The milestones will be evaluated as part of the scientific and technical merit of the R61/R33 application. Completion of the milestones will be reviewed administratively by NEI to assess eligibility to transition to the R33 phase. For the R33 phase, a timeline should be provided at the end of the approach section.

Dissemination strategies that will enhance the translational impact of the intervention/tool should be described and include the timeframe, expanded access, affordability, and process for evaluating success of the dissemination effort. Letters of Support: All collaborating institutions and key personnel should provide letters of support for the proposed research program.

Letters of support from collaborating institutions should be supplied by institutional leaders. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

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

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by 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.

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.

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. 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 NEI, NIH. Applications that are incomplete, non-compliant, or non-responsive will not be reviewed.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Applicants may also submit a 1-page document with preliminary data that was obtained since the application was submitted. The document should not contain any links or videos. Section V.

Application Review Information 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 NOFO, note the following: The R61/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research.

An R61/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.

Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes both the R61 and R33 phases.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or