Content provided by the Catalog of Federal Domestic Assistance
93.867 Vision Research
NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
To support eye and vision research projects that address the leading causes of blindness and impaired vision in the U.S. These include retinal diseases, such as diabetic retinopathy and macular degeneration; corneal diseases; cataract; glaucoma; strabismus; amblyopia; and low vision and its rehabilitation. To increase understanding of the normal development and function of the visual system; to understand the causes of, and to better prevent, diagnose, and treat sight-threatening conditions; and, to enhance the rehabilitation, training, and quality of life of individuals who are partially-sighted or blind. To support a broad program of basic vision research through grants and cooperative agreements; to encourage high quality clinical research, including clinical trials, other epidemiologic studies, and health services research; to encourage research training and career development in the sciences related to vision; and to sponsor scientific workshops in high priority research areas to encourage exchange of information among scientists. Small Business Innovation Research (SBIR) program: To increase private sector commercialization of innovations derived from Federal research and development; to encourage small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. Small Business Technology Transfer (STTR) program: To stimulate and foster scientific and technological innovation through cooperative research development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
TYPES OF ASSISTANCE:
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 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, the Mentored Scientist Development Award in Research Ethics, and the Mid-career Investigator Award in Patient-Oriented Research. Clinical Vision Research Development Awards are intended to help investigators develop the staff and other resources needed to enhance programs of clinical vision research through the application of epidemiology and biostatistical methodology to clinical problems. The Clinical Study Planning Grant is designed to support the development of an applied clinical research plan. Small Grants for 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. Small Grants for Pilot Research provide limited support to allow investigators to collect preliminary data in feasibility studies for which a successful outcome would have a major effect on vision research. 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. Collaborative Research 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. The Collaborative Program on Retinal Degenerative Disease Research is a collaboration with the Foundation Fighting Blindness to stimulate basic cellular, molecular, genetic, and clinical research on retinal degenerative diseases. The program on The Role of Growth Factors in the Development of Diabetes Complications supports research directed toward an understanding of the tissue- and cell-specific expression of growth factors in the eye and of the molecular action of these growth factors in the pathophysiology of ocular diabetic complications. 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 research initiated in 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.
Applicant Eligibility: Universities, colleges, hospitals, laboratories, federal institutions and other public or private nonprofit and for-profit domestic institutions, including small businesses, 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. citizens, 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.
Pre-application Coordination: Applicants for core grants, clinical vision research development awards, clinical study planning grants, cooperative agreements for clinical studies or conferences, 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. 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. This program is excluded from coverage under E.O. 12372.
Formula and Matching Requirements: This program has no statutory formula or matching requirements.
POST ASSISTANCE REQUIREMENTS:
Reports: 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 results, positive and negative, that are considered significant by the investigator; and a list of any publications resulting from the projects. Also, for most projects a financial status report is required 90 days after each competitive segment. However, selected mechanisms such as cooperative agreements and Institutional NRSAs require an annual financial status report. NRSAs (Institutional) Statement of Appointment for each trainee selected by the Program Director must be submitted to the National Eye Institute for each year of training, not to exceed 3 years. Reports are required after termination of the NRSAs to ascertain compliance with the service and pay back provisions for each institutionally selected trainee.
Account Identification: 75-0887-0-1-552.
In fiscal year 2001, this program supported approximately 1,522 research grants, including 49 SBIR and STTR awards, and 267 NRSA awards. This program received approximately 987 competing research grant applications in fiscal year 2001, of which approximately 392 competing applications were funded, with an estimated success rate of 39.7 percent. In fiscal year 2002, the program anticipate to support 1,460 research grants, including 54 SBIR and STTR awards, and 267 NRSA awards. These same numbers are anticipated in fiscal year 2003. A report by the National Advisory Eye Council, "Vision Research - A National Plan: 1999-2003," provides a comprehensive summary of the program's goals, objectives, accomplishments, research budget, and program and management policies, as well as statistical information on the incidence, prevalence, and cost of visual disorders. Copies of this document are available on the internet at http://www.nei.nih.gov or from: Office of Science Policy and Legislation, National Eye Institute, Building 31, Room 6A25, 31 Center Drive, MSC 2510, Bethesda, MD 20892- 2510.
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 for Support for Clinical Trials in Vision Research, Participating Clinics in Multicenter Clinical Trials, Clinical Study Planning Grant, Clinical Vision Research Development Award, Small Research Grants for Data Analyses, NRSA Institutional Research Training Grants, Mentored Clinical Scientist Development Award, Core Grants for Vision Research, and Support of Scientific Meetings. 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: Not applicable.
EXAMPLES OF FUNDED PROJECTS:
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.