NEI Audacious Goal Initiative: Discovery-based Science to Identify Factors Influencing Neural Regeneration in the Visual System

NEI Audacious Goal Initiative: Discovery-based Science to Identify Factors Influencing Neural Regeneration in the Visual System is sponsored by National Eye Institute (NEI). Supports discovery-based research to identify factors influencing neural regeneration in the visual system.

Expired RFA-EY-15-002: NEI Audacious Goal Initiative: Discovery-based Science to Identify factors Influencing Neural Regeneration in the Visual System (U01) 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 ) of Participating Organizations National Eye Institute ( NEI ) Funding Opportunity Title NEI Audacious Goal Initiative: Discovery-based Science to Identify Factors Influencing Neural Regeneration in the Visual System (U01) U01 Research Project Cooperative Agreements Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The NEI Audacious Goal Initiative (AGI; see https://www. nei. nih.

gov/audacious ) is to restore vision through regeneration of neurons and neural connections in the eye and visual system. Recent advances have identified molecules and signaling pathways that can either promote or inhibit regeneration of neurons in the visual pathway. These advances have led to significant axon growth in mouse optic-nerve crush and other regeneration models.

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing to use discovery-based approaches to identify unknown factors critical to the regeneration of neurons, guiding their axons to targets, and making new functional connections. Future FOAs will focus on understanding the biological mechanisms through which these factors influence regeneration.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) January 15, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. 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.

AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description The National Eye Institute (NEI) hosted a workshop on optic nerve regeneration on November 19, 2014 as part of the Audacious Goals Initiative (AGI), an NEI-led effort to restore usable vision in humans by regenerating neurons and neural connections in the visual system.

A second workshop was convened on May 2, 2015, to discuss regeneration of photoreceptors. The principal objective of these workshops was to identify gaps in knowledge, barriers to progress, and promising strategies for achieving regeneration. Neurons in mammalian central nervous systems extend axons and innervate appropriate targets during developmental stages, but are unable to do so following disease or injury in adults.

Some non-mammalian species like zebrafish are capable of regenerating central neural axons and connections, even as adults. Progress has been made in identifying factors that either stimulate or inhibit regeneration; manipulation of these factors has resulted in some regeneration. Recent evidence from these models indicates that certain subtypes of retinal ganglion cells regenerate better than others.

There may be other factors beyond those already identified that are involved in the regeneration and reconnection of neurons in the retina and lateral geniculate Although there has been some success in regenerating neurons and connections in fish, mice, and other systems, the ultimate goal of the AGI is to restore vision in humans.

The specializations of the macula, differences in cell types, and long distance required for axon growth in humans represent some of the major challenges. Animal models that more closely resemble the human visual system will be important for advancing the AGI. Discovery-based approaches using emerging or current technologies could be used to address these challenges and gaps in knowledge.

High-throughput screening, for example, could identify factors currently not known to be involved in regenerating and reconnecting neurons. Innovative methods are also needed to determine if the factors identified by screening do in fact have a significant role in regeneration.

Approaches comparing models that differ in their regenerative capacity may also be valuable for identifying new factors crucial for successful regeneration and reconnection of neurons.

Areas of Research Interest This FOA invites applications proposing discovery-based approaches to identify and validate unknown factors involved in regenerating photoreceptors and their connections to bipolar cells, and/or retinal ganglion cells and their connections to the LGN.

Areas of investigation under this FOA include, but are not The discovery of unknown genes, transcription factors, and signaling molecules that enable neurons to regenerate Identifying cues that guide axons to appropriate targets Innovative high-throughput strategies for screening, and assays for evaluating the role of identified factors in the regeneration process Experimental approaches comparing models that differ in their regenerative capacity, such as fish versus mammals, comparing developmental stages to adults, or comparing specific cell types Testing newly identified factors in model systems that more closely approximate regeneration and reconnection in the human visual system The goal of this FOA is to discover new factors promoting regeneration and reconnection; applications focusing on neuroprotection or previously identified factors in retinal and optic-nerve regeneration will NOT be considered responsive to this FOA.

These projects will be milestone-driven. Milestones and timelines will be submitted by the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) in the initial application. These milestones will be refined and evaluated on an ongoing basis.

Adjustment of project aims and budgets by the NEI may be required based on the progress of the project toward meeting its There will be expectations for early sharing of information, preliminary results, raw data, resources, and technology (see the Resource Sharing Plan - Section IV and the Primary responsibilities of the PD(s)/PI(s) - Cooperative Agreement Terms and Conditions of Award - Section VI).

This FOA strongly encourages the establishment of investigative teams that are multidisciplinary with the complementary expertise required for genetic screening and development of assays in appropriate species. Projects will be selected for funding based not only on the results of their scientific and technical review, but also to create a comprehensive and inclusive effort to advance the AGI.

The NEI will establish a consortium consisting of the investigative teams funded under the FOA who will collaborate to achieve the overall goals of the AGI. Scientific Oversight Committee The NEI will provide oversight of these projects in conjunction with an External Scientific Oversight Committee (ESOC).

The ESOC will be composed of scientific experts, chosen by the NEI in consultation with the PD(s)/PI(s), who will closely monitor progress in meeting the milestones of all projects funded under this FOA, and will provide recommendations to the PD(s)/PI(s) and to the NEI.

This Committee will assist the NEI in evaluating attainment of project milestones and will provide an extra level of scrutiny for programmatic relevance and progress in cases where adjustments in funding may be required. The ESOC will provide guidance on integrating principles aimed at achieving the Section II.

Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The NEI intends to commit a total of $3-5M in FY2016 Application budgets are limited to $500,000 annual direct costs (including the direct costs of any subcontracts proposed), and must reflect the actual needs of the proposed project. The project period is limited to three years.

Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions 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 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 Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to 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 SF 424 (R&R) 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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) 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. 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.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

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 must have an active DUNS number and SAM registration in order to complete the 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 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 his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 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.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission 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 NOT-OD-11-101 ). Section IV. Application and Submission Information Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.

gov . 2. Content and Form of Application Submission It is critical that applicants follow the instructions in (R&R) Application Guide , including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement 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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant 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 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 SF424 Application Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide Funds for attending the annual Principal Investigator meeting should be included.

All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Aims: This section should focus on addressing scientific needs for achieving the NEI AGI.

It must identify clear and measurable milestones that include specific timelines and criteria for evaluation. Strategy: This section should discuss how the proposed experiments relate to achieving the AGI goal of restoring vision through regeneration of neurons and neural connections in the eye and vision system.

It must include a discussion of the experiments designed to achieve the proposed milestones, as well as any potential pitfalls and alternate strategies.

This section should describe how the project will move the field closer to achieving the AGI and describe the research team as a whole and how proposed collaborations will bring together new combinations of investigators and Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: the plan should describe the sharing of information, preliminary results, raw data, resources and technology with the NEI, the ESOC, and the other investigative teams (i.e., recipients of awards issued under this FOA) and the sharing of data, final results, and technology with the broader research community after publication Program Directors(s)/Principal Investigator(s) are expected to attend an annual investigator meeting to share information and ideas, foster collaborations, and accelerate progress toward the AGI.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Planned Enrollment Report When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) PHS 398 Cumulative Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. See Part I. Section III.

1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates.

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. 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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 SF424 (R&R) Application Guide. 4.

Intergovernmental Review This initiative is not subject to intergovernmental 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 .

Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Electronically .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must for Applicants Experiencing System Issues . All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package .

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 FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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.

Applications unrelated to the AGI or focusing on neuroprotection or previously identified factors in retinal and optic nerve regeneration will NOT be considered responsive to this FOA. Applicants are encouraged to contact the NEI Scientific/Research Contact listed at the end of this FOA to discuss the programmatic priorities of the NEI prior to submission.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030. Section V. Application Review Information Only the review criteria described below will be considered in the review process.

As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer Consistent with the FOA's call for discovery-based approaches to identify unknown factors critical to the regeneration of neurons, guiding their axons to targets, and making new functional connections, projects that are not hypothesis driven may be appropriate.

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 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?

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?

Will this project move the field closer to achieving the AGI goal of restoring vision through regeneration of neurons and neural connections in the eye and visual system? Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?

If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the research team appropriate?

Will the collaboration bring together new combinations of investigators and Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?

Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the application challenge existing knowledge by proposing to discover and test the significance of unknown factors relevant to regeneration and reconnection of neurons in the visual system?

Will the approaches, methodologies, or technologies likely lead to a transformative understanding of regeneration? Will the model system bring us closer to an understanding of regeneration and reconnection in the human Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?

If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Does the applicant propose appropriate milestones, timelines, and evaluation criteria?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate Protections for Human Subjects For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will 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 six categories of research that are exempt under 45 CFR Part 46, the committee will 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 Inclusion of Women, Minorities, When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.

For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate 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.

Applications from Foreign Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan ; 2) Sharing Model Organisms ; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan .

Budget and Period of Support Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NEI, in review policy and procedures , using the stated review criteria .

Assignment to a Scientific Review Group will be shown in the eRA As part of the scientific peer review, all 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 Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Eye Council.

The following will be considered in making funding decisions: Scientific and technical merit of the proposed project as determined by scientific peer review. Relevance of the proposed project to program priorities. Compliance with data and resource sharing policies as appropriate.

Multidisciplinary collaborations. Potential to advance the AGI. 3.

Anticipated Announcement After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) Information regarding the disposition of applications is Grants Policy Statement . Administration Information If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as Grants Policy Statement .

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official. Awardees must comply with any funding restrictions described in Section IV.

5. Funding Restrictions . Selection of an application for award is not an