(1) Retinal Diseases: Projects include studies of the development, molecular and cell biology, molecular genetics, and metabolism of the photoreceptor cells and the underlying retinal pigment epithelium; the mechanism of the retina's response to light and the initial processing of information that is transmitted to the visual centers of the brain; the pathogenesis of diabetic retinopathy; the fundamental causes of and etiologic factors responsible for uveitis; the molecular genetic mechanisms underlying retinoblastoma and ocular melanoma; the genetics of retinitis pigmentosa, age-related macular degeneration, and related disorders; and the cellular and molecular events that accompany retinal detachment.
(2) Corneal Diseases: Projects include studies of the regulation of genes that express proteins unique to corneal tissue; the details of the macromolecular and supramolecular assembly of extracellular corneal matrices; the characterization of cytokines and cell surface receptors which interact with corneal cells, pathogens, and blood borne cells; the pathogenesis of corneal infections; the mechanisms that maintain corneal hydration and transparency; the physiologic basis for immune privilege in the cornea; corneal development, growth, and wound healing; the biomechanics of the cornea; the characterization of genes responsible for corneal dystrophy; and, the correction of refractive errors.
(3) Lens and Cataract: Projects include studies of lens development, characterization of changes in lens physiology and biochemistry related to aging and cataract formation, the identification of those molecular components and physiological processes required to maintain transparency, studies to identify what controls lens shape and its accommodative dynamics, the molecular and cellular characterization of the control of lens cell division and differentiation; genetic studies to map and identify cataract genes, studies to describe the structure and function of lens crystallins, and studies to identify those insults that lead to cataract formation such as oxidative stress.
(4) Glaucoma and Optic Neuropathies: Projects include studies of the genetics of glaucoma, the cellular and molecular nature of the extracellular matrix proteins of the trabecular meshwork; the basic mechanisms that control aqueous humor dynamics; the design of better pharmacologic agents to modulate aqueous humor secretion and outflow, and characterization of mechanisms of optic nerve damage and the cell biology of retinal ganglion cell death.
(5) Strabismus, Amblyopia, and Visual Processing: Projects include studies of the function of the neural pathways from the eye to the brain, the central processing of visual information, visual perception, optical properties of the eye, functioning of the pupil, and control of the ocular muscles; congenital, developmental, and degenerative abnormalities of the visual sensorimotor system, particularly strabismus and amblyopia.
Additional emphasis is placed on and support provided for research on optic neuropathies, eye movement disorders, and the development of myopia.
(6) Low Vision and Blindness Rehabilitation: Projects include studies aimed at improving the methods of specifying, measuring and categorizing loss of visual function; devising strategies to help visually impaired people maximize the use of their residual vision; systematically evaluating new and existing visual aids; developing an adequate epidemiological base for blindness, partial loss of sight and visual anomalies; and studying the optical, electronic, and other rehabilitative needs of people with visual impairments.
(7) Collaborative Clinical Research: Projects include a number of clinical trials and other epidemiologic research projects including single-center randomized clinical trials, multicenter randomized clinical trials, natural history studies, risk factor analyses using case-control and prospective cohortmethods,and health services research.
These projects have the goal of improving the understanding, the prevention, and the management of visual system diseases and disorders including, for example, diabetic retinopathy, age-related macular degeneration, corneal diseases, cataract, glaucoma, and optic nerve atrophy, the leading causes of blindness in the United States.
The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.
In FY 07, this program supported approximately 1,450 research grants, including 58 SBIR and STTR awards, and 267 NRSA positions. This program received approximately 984 competing research grant applications in FY 07, of which approximately 262 competing applications were funded, with an estimated success rate of 26.6 percent. In FY 08, the program anticipates supporting 1,400 research grants, including 48 SBIR and STTR awards, and 267 NRSA positions. A report by the NEI, "National Plan for Eye and Vision Research" provides a comprehensive summary of the program's goals, objectives, accomplishments, and program and management policies, as well as statistical information on the incidence and prevalence of visual disorders. Copies of this document are available on the internet at http://www.nei.nih.gov.
Uses and Use Restrictions
Research grants and cooperative agreements provide funds for salaries, consultant costs, equipment, supplies, travel, patient costs, alterations and renovations, other expenses, and consortium/contractual costs.
The scientists and institutions are under an obligation to expend grant funds prudently for the purposes as stated in the application and award document.
The Conference Cooperative Agreement supports scientific meetings and workshops in high priority research areas to encourage exchange of information among scientists.
The Center Core Grant is intended to enhance an institution's environment and capability to conduct vision research, to facilitate collaborative studies of the visual system and its disorders, and to attract scientists of diverse disciplines to research on the visual system.
Career development awards include the Mentored Clinical Scientist Development Award, Mentored Patient-Oriented Research Career Development Award, Institutional Clinical Scientist Development Program, and the Mid-career Investigator Award in Patient-Oriented Research.
The Clinical Study Planning Grant is designed to support the development of an applied clinical research plan.
NEI Research Grants for Secondary Data Analysis provide limited support for meritorious research projects that involve secondary analysis of research data generated from clinical trials, population research and other applied clinical vision research projects supported by the Institute.
Bioengineering Research Grants (BRG) support basic bioengineering research whose outcomes are likely to advance health or health-related vision research.
BRGs may propose to apply basic bioengineering design-directed or hypothesis-drive research to an important vision research area.
Bioengineering Research Partnership grants support multidisciplinary research teams applying an integrative, systems approach to develop knowledge and/or methods to prevent, detect, diagnose, or treat diseases of the eye and visual system.
NEI Translational Research Program on Therapy for Visual Disorders grants provide support to collaborative, multidisciplinary research focused on the development of novel therapies to restore or prevent the loss of function due to visual diseases and disorders.
Small Business Innovation Research Phase I grants are awarded to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process.
Phase II grants are for the continuation of the research initiated in Phase I that is likely to result in commercial products or processes.
Only Phase I awardees are eligible to apply for Phase II support.
Small Business Technology Transfer Research, Phase I grants are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application.
Phase II funding is based on results of researchinitiatedin Phase I and scientific and technical merit and commercial potential on Phase II application.
National Research Service Awards (NRSAs), both individual and institutional, support training in vision research.
Some individuals who receive an NRSA may be obligated upon termination of the award to comply with certain service and payback provisions.
The NIH Extramural Loan Repayment Programs provides payback of a portion of eligible student loan debt of qualified health professionals who agree to conduct clinical research.linical research.
Public/State-controlled institutions of higher education, private institutions of higher education, Hispanic-serving institutions, Historically Black Colleges and Universities, tribally-controlled colleges and universities, Alaska Native- and Native Hawaiian-serving Institutions, nonprofits with or without 501(c)(3) IRS status, Small Businesses, for-profit organizations, federal institutions, and State and local units of government are eligible to make application for research grants, cooperative agreements, and career development awards.
Foreign institutions may apply for research grants only.
The grantee institution must agree to administer the grant in accordance with prevailing regulations and policies.
Candidates for Mentored Clinical Scientist Development Awards are restricted to those holding health professional degrees in the clinical sciences (M.D., O.D., D.D.S., D.V.M., or equivalent).
NRSAs are provided for predoctoral and postdoctoral research training.
Individual NRSAs may be made for applicants who hold a professional or scientific degree (M.D., Ph.D., O.D., D.D.S., D.V.M., Sc.D., D.Eng., or equivalent degree).
Institutional NRSAs may be made for both predoctoral and postdoctoral research training.
Predoctoral awardees must have completed the baccalaureate degree.
All awardees must be citizens of the United States, or have been admitted to the U.S.
for permanent residence prior to award.
Individual NRSA awardees must be nominated and sponsored by a Federal, public or private nonprofit institution having staff and facilities suitable to the proposed research training.
Federal and for-profit organizations, and State and local governments may not apply for an institutional NRSA.
Refer to the NIH Program Guidelines on NRSAs for further information.
The Small Business Innovation grants: SBIRs can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have not more than 500 employees).
Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of the award and during the conduct of the proposed project.
The research during both Phase I and Phase II must be performed in the U.S.
or its possessions.
Only Phase I awardees are eligible to receive Phase II support.
STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more that 500 employees) which "partner" with a research institution in cooperative research and development.
At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution.
In both Phase I and Phase II, the research must be performed in the U.S.
and its possessions.
Individuals applying for the NIH Loan Repayment Programs must be engaged in patient oriented research and be trained in a medical subspecialty as defined under Section 206 of Public Law 106-505.
These individuals must be U.S.
citizen nationals, or lawfully admitted for permanent residence in the U.S.; have a student loan debt which equals or exceeds 20 percent of their university compensation; have no Federal judgment lien against their property arising from a Federal debt; and owe no obligation of health professional service to the Federal government, a State, or other entity unless deferrals are granted during the length of their Loan Repayment Program service obligation.
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
(1) Research grants and cooperative agreements: Applications for research involving the use of human subjects must include documentation that all key personnel have received training in human subject protection. Applicants may provide additional documentation to establish the scientific and technical merit and the programmatic relevance of the application. (2) Individual NRSA applications: The applicant's academic record, research experience, institutional sponsorship, and the proposed area and plan of training must be included. (3) Institutional NRSA application: The applicant institution must discuss the objectives, methodology and resources for the research training program; the qualifications and experience of staff; the criteria to be used in selecting individuals for an appointment; and a budget and justification for the grant funds requested. Costs will be determined in accordance with the appropriate OMB Circular or with HHS Regulations 45 CFR, Part 74, Subpart Q. (4) For SBIR and STTR grants, the small business concern must present a research plan that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Loan Repayment Program applicants must provide certification of loan status, loan data verification, and an institutional supporting statement.
Aplication and Award Process
Applicants for core grants, clinical study planning grants, cooperative agreements, clinical vision research development awards, small research grants for data analyses, and bioengineering research partnerships should seek preapplication coordination through contact with the National Eye Institute staff.
All staff may be contacted at (301) 451-2020.
Applicants planning to submit a grant application requesting $500,000 or more in direct costs for any year are required to discuss their eligibility with the NEI staff, at (301) 451-2020.
This program is excluded from coverage under E.O.
Standard application forms, as required by 45 CFR, Part 74 and 92, must be used for this program. Prior to making formal application to the NRSA programs, individual NRSA applicants must be nominated and sponsored by a federal, public, or nonprofit institution having staff and facilities appropriate to the proposed research program. Information regarding the application process, access to forms, and information regarding the httP//www.Grants.Gov site are available on the NEI web site at http://www.nei.nih.gov. Supplemental instructions for preparing applications for Core Grants, Mentored Clinical Scientist Development Awards, Clinical Study Planning Grants, and cooperative agreements for clinical studies or conferences are available on the internet at http://www.nei.nih.gov/ SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at http://www.nih.gov/grants/funding/sbir.htm on the World Wide Web. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. Application forms and information concerning the NRSA program are available from the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892, and should be submitted to the same address. National Eye Institute guidelines and supplemental instructions for preparing Institutional NRSA applications are available on the World Wide Web at http://www.nei.nih.gov/ This program is subject to the provisions of 45 CFR 74 and 92 and OMB Circular No. A-110 for nonprofit organizations, as applicable.
Applications are reviewed initially for scientific and technical merit. A second level review of the programmatic relevance of applications is provided by the National Advisory Eye Council. (Second level review of NRSA fellowship applications is performed by a committee of senior staff of the National Eye Institute. Final approval is made by the Director, National Eye Institute. Formal award notices are transmitted to the appropriate institutional official.
Receipt dates for all NIH-supported grant and cooperative agreement mechanisms are available at http://grants.nih.gov/grants/funding/submissionschedule.htm.
Public Health Service Act, as amended, Title III, Part A, Section 301; Health Research Extension Act of 1985, Public Law 99-158, 42 U.S.C. 241; Title IV, Part B, Section 405; 42 U.S.C. 284; Part C, Section 455; 42 U.S.C. 285i; Health Omnibus Programs Extension Act of 1988, Section 487(d); Public Law 100-607, 42 U.S.C. 288(d); Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Range of Approval/Disapproval Time
Approximately six to nine months for Research Grants, Mentored Clinical Scientist Development Awards, Clinical Study Planning Grants, cooperative clinical studies or conferences, Core Grants, and NRSA Institutional applications; from six to seven months for NRSA individual applications; and for SBIR, about eight months.
A principal investigator may communicate to the staff of the National Eye Institute any concerns regarding the substantive or procedural aspects of the review of an application.
Renewals of research grant or cooperative agreement support are by competitive application and review. Mentored Clinical Scientist Development Awards, Clinical Study Planning Grants, and NEI Research Grants for Secondary Data Analysis are non-renewable.
Formula and Matching Requirements
This program has no statutory formula or matching requirements.
Length and Time Phasing of Assistance
Up to five years for research grants and cooperative agreements, Mentored Clinical Scientist Development Awards, Core Grants, and Institutional NRSAs. Up to three years for Academic Research Enhancement Awards and NRSA Individual postdoctoral awards. Clinical Study Planning Grants: one year. Awards to individuals made through an institutional NRSA may total eight years (five years predoctoral and an additional three years postdoctoral). SBIR: Normally, Phase I awards are for six months; normally, Phase II awards are for two years. STTR: Normally, Phase I awards are for one year; normally, Phase II awards are for two years. Loan Repayment Program Awards are for two years with the opportunity for renewal.
Post Assistance Requirements
The grantee is responsible for annual progress reports.
These are required for program analysis as part of all continuation applications.
In addition, a final report is required to be filed within 90 days of the termination of the grant.
The final report includes an account of progress made toward achievement of the originally stated aims; a list of the significant results; and a list of publications resulting from the projects.
For most projects a financial status report is required 90 days after each competitive segment.
Cooperative agreements and Institutional NRSAs require an annual financial status report.
NRSAs (Institutional): A Statement of Appointment for each trainee must be submitted to the National Eye Institute for each year of training, not to exceed three years.
Reports are required after termination of the NRSAs to ascertain compliance with the service and pay back provisions for each trainee.
In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), nonfederal entities that expend financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. Grants and cooperative agreements are also subject to inspection and audits by DHHS and other Federal government officials. Loan Repayment Program awards will be audited prior to the end of the contract or as needed.
Expenditures and other financial records must be retained for three years from the day on which the grantee submits the last expenditure report for the report period.
(Grants and Cooperative Agreements) FY 07 $508,095,000; FY 08 est $507,383,000; and FY 09 est $506,627,000. (NRSA): FY 07 $10,606,000; FY 08 est $10,608,000 and FY 09 est $10,661,000. (SBIR and STTR): FY 07 $18,980,000; FY 08 est $15,782,000; and FY 09 est $15,760,000.
Range and Average of Financial Assistance
Grants and Cooperative agreements: $26,298 to $5,057,448; $392,655. NRSA (Institutional): $26,298 to $560,041; $217,314. NRSA (Individual): $14,476 to $62,002; $45,355. SBIR Phase I: $99,231 to $570,438; $130,023. SBIR Phase II: $71,484 to $953,134; $431,300. STTR Phase I: $105,906 to $310,645; $188,551. STTR Phase II: $310,719 to $408,108; $346,016.
Regulations, Guidelines, and Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92. PHS Grants Policy Statement DHHS Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994, and Addendum effective February 15, 1995; "NIH Guide for Grants and Contacts and Supplements." National Eye Institute Guidelines are available on the internet at http://www.nei.nih.gov Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Regional or Local Office
Jerome R. Wujek, Ph.D., Research Resources Officer, National Eye Institute, National Institutes of Health, Department of Health and Human Services, Room 1300, 5635 Fishers Lane, Bethesda, MD 20892-1900. Telephone: (301) 451-2020. Grants Management Officer Contact: Mr. William W. Darby, Chief, Grants Management Branch, National Eye Institute, National Institutes of Health, Department of Health and Human Services, Room 1300, 5635 Fishers Lane, Bethesda, MD 20892-1900. Telephone: (301) 451-2020. Use the same numbers for FTS. The National Eye Institute encourages applicants to visit its internet site at www.nei.nih.gov/. Among the many recent additions to the site is an expanded "Research Funding" section which contains all National Eye Institute application guidelines and internet links to relevant NIH information.
Criteria for Selecting Proposals
The major elements in the initial scientific and technical review of most applications include an assessment of significance, approach, innovation, investigator training and experience, and the scientific environment. In addition to these criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: the adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research; the reasonableness of the proposed budget and duration in relation to the proposed research; and, the adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. A second level review of the programmatic relevance of most applications is provided by the National Advisory Eye Council. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.
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