FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

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:

Project Grants. Place Cursor Here for Definition

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.

ELIGIBILITY REQUIREMENTS:

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.

Beneficiary Eligibility:   Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation:   (1) Research grants and cooperative agreements: Applicants applying for research involving the use of human subjects must submit documentation that all key personnel have received training in human subject protection. No additional credentials or documentation are required with application, except for those that the applicant feels will help establish the scientific and technical merit and the programmatic relevance of his/her 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 in the application. (3) Institutional NRSA application: The applicant institution must discuss the objectives, methodology and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for an award, and a detailed budget and justification for the amount of grant funds requested. Costs will be determined in accordance with the appropriate OMB Circular or in accordance with HHS Regulations 45 CFR, Part 74, Subpart Q. (4) For SBIR and STTR grants, the applicant organization (small business concern) must present in a research plan an idea 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. Grant form PHS 350 (rev. 05/2000 is used to apply for SBIR and STTR grants. Loan Repayment Program applicants must provide certification of loan nondelinquent status, loan data verification, and an institutional supporting statement.

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.

Application Procedure:   Standard application forms, as required by 45 CFR, Part 74 and 92, must be used for this program. Applicants to the Cooperative Program on Retinal Degenerative Disease Research who wish to be considered for funding by the FFB must submit a brief letter of authorization. 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. An application form, PHS-398 (Rev.4/98), for research grant and cooperative agreement awards may be requested from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910. Telephone: 301 435-0714, e-mail: ASKNIH@odrockml.od.nih.gov and should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. Supplemental instructions for preparing applications for Core Grants, Mentored Clinical Scientist Development Awards, Clinical Vision Research Development Awards, Clinical Study Planning Grants, Small Research Grants for Data Analyses, and cooperative agreements for clinical studies or conferences are available on the internet at http://www.nei.nih.gov/ or they can be requested from National Eye Institute staff. 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. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710. 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/ or can be obtained from the National Eye Institute, EPS 350, 6120 Executive Boulevard, MSC 7164, Bethesda, MD 20892-7164. This program is subject to the provisions of 45 CFR 74 and 92 and OMB Circular No. A-110 for nonprofit organizations, as applicable.

Award Procedure:   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 are reviewed by a committee comprised of senior staff of the National Eye Institute. Final approval is made by the Director, National Eye Institute. Formal award notices are then transmitted to the appropriate institutional official. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by the National Advisory Eye Council. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines:   New research grants and cooperative agreements: February 1, June 1, and October 1. Renewal, revised, and supplemental applications: March 1, July 1, and November 1. Academic Research Enhancement Award: January 25, May 25, September 25. NRSA Individual Postdoctoral fellowship: April 5, August 5, and December 5. NRSA Individual Predoctoral Fellowship for Minority Students or Students with Disabilities: May 1 and November 15. NRSA Institutional: May 10. SBIR and STTR: April 1, August 1, and December 1. Core Grants: August 27. AIDS ASAP grants: January 2, May 1, and September 1. Loan Repayment Program applications: February 1.

Range of Approval/Disapproval Time:   Approximately 6 to 9 months for Research Grants, Mentored Clinical Scientist Development Awards, Clinical Vision Research Development Awards, Clinical Study Planning Grants, cooperative clinical studies or conferences, Core Grants, and NRSA Institutional applications; from 6 to 7 months for NRSA individual applications; and for SBIR, about 7-1/2 months.

Appeals:   A principal investigator may communicate to the staff of the National Eye Institute any concerns he/she may have about the substantive or procedural aspects of the review of an application.

Renewals:   Renewals of research grant or cooperative agreement support are by competitive application and review. Mentored Clinical Scientist Development Awards, Clinical Research Development Awards, Clinical Study Planning Grants, Small Grants for Data Analysis, and Small Grants for Pilot Research are non-renewable.

ASSISTANCE CONSIDERATIONS:

Formula and Matching Requirements:   This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance:   Up to 5 years for research grants and cooperative agreements, Mentored Clinical Scientist Development Awards, Core Grants, Clinical Vision Research Development Awards and NRSAs (Institutional). Academic Research Enhancement Award, up to 3 years. Clinical Study Planning Grants: 1 year. Up to 3 years for NRSA postdoctoral awards (Individual Awards to individuals made through a NRSA (Institutional may total 8 years (5 years as a predoctoral and an additional 3 years as a postdoctoral). Assistance is available for each budget period, usually 1 year. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years. Loan Repayment Program Awards are for two years with the opportunity for renewal.

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.

Audits:   In accordance with the provisions of OMB Circular No. A- 133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Nonprofit Organizations," 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 in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are 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.

Records:   Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.

FINANCIAL INFORMATION:

Account Identification:   75-0887-0-1-552.

Obligations:   (Grants and Cooperative Agreements) FY 01 $413,909; FY 02 est $464,194,000; and FY 03 est $502,717,000. (NRSA): FY 01 $9,762,000; FY 02 est $11,624,000; and FY 03 est $12,164,000. (SBIR and STTR): FY 01 $12,096,000; FY 02 est $13,234,000; and FY 03 est $14,341,000.

Range and Average of Financial Assistance:   Grants and cooperative agreements: $13,675 to $5,096,101. Average: $302,628. NRSA (Institutional): $18,842 to $494,340. Average: $160145. NRSA (Individual): $20,356 to $52,712. Average: $37,325. SBIR Phase I: $$84,640 to $135,594. Average: 102,811. SBIR Phase II: $150,593 to $555,256. Average: $388,841. STTR Phase I: $99,984 to $111,070. Average: $105,083. STTR Phase II: $245,726 to $245,726. Average: $245,726.

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.

INFORMATION CONTACTS:

Regional or Local Office:   Not applicable.

Headquarters Office:   Dr. Ralph J. Helmsen, Research Resources Officer, National Eye Institute, National Institutes of Health, Department of Health and Human Services, EPS 350, 6120 Executive Boulevard MSC 7164, Bethesda, MD 20892-7164. 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, EPS 350, 6120 Executive Boulevard MSC 7164 Bethesda, MD 20892-7164. Telephone: (301) 451-2020. Use the same numbers for FTS. The National Eye Institute encourages prospective applicants to visit its internet site at www.nei.nih.gov/. Among the many recent additions to the site is an expanded "Funding Information/Grants and Contracts" section which contains all National Eye Institute application guidelines and internet links to relevant NIH sites.

Web Site Address:   http://www.nei.nih.gov

EXAMPLES OF FUNDED PROJECTS:

(1) Retinal Diseases: Projects include studies of the development, molecular and cell biology, molecular genetics, and metabolism of the photoreceptor cells and their dependence on 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 characterization at the molecular level of the genes responsible for 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, at the cellular and molecular level, of those components and physiological processes required to maintain transparency, studies to identify what controls lens shape and its accommodating 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; studies to identify those insults that lead to cataract formation such as oxidative stress, and, the role of aldose reductase in human cataractogenesis. (4) Glaucoma: Projects include studies of the genetics of glaucoma, characterizing at the cellular and molecular level the extracellular matrix proteins of the trabecular meshwork; elucidating the basic mechanisms that control aqueous humor dynamics; designing 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.

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.