COOPERATIVE PROGRAM ON RETINAL DEGENERATIVE DISEASE RESEARCH Release Date: November 10, 1999 PA NUMBER: PA-00-009 National Eye Institute THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Eye Institute (NEI) and the Foundation Fighting Blindness (FFB) announce a cooperative program of research support on retinal degenerative diseases. This program announcement (PA) signals the interest of NEI and FFB in funding grant applications that meet the programmatic interests of the NEI and FFB in the area of retinal degenerative diseases. The PA is intended to stimulate basic cellular, molecular, genetic, and clinical research on retinal degenerative diseases. Applications in response to this PA will use the following grant mechanisms: research project grant (R01), Small Business Technology Transfer Grants (STTR) (R41 and R42), Small Business Innovation Research Grants (SBIR) (R43 and R44), Mentored Clinical Scientist Development Award (K08), Mentored Patient-Oriented Research Career Development Award (K23), and Midcareer Investigator Award in Patient-Oriented Research (K24). Each of these mechanisms vary in eligibility, applications procedures, review criteria, etc. Pay particular attention to the variances in the mechanisms when applying under this PA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000", a PHS led national activity for setting priority areas. This PA, Cooperative Program for Research on Retinal Degenerative Diseases, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. RESEARCH PROJECT GRANTS (R01) A. ELIGIBILITY REQUIREMENTS Applications for R01 grants may be submitted by domestic and foreign, for- profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at https://grants.nih.gov/grants/funding/modular/modular.htm. B. SMALL BUSINESS GRANTS (R41, R42, R43, R44) ELIGIBILITY Eligibility requirements for applications for Phase I STTR grants (R41) are described in the Omnibus Solicitation of the National Institutes of Health for STTR Grant Applications (PHS 99-3), which is available at https://grants.nih.gov/grants/funding/sttr1/toc.htm . Eligibility requirements for applications for Phase II STTR grants (R42) are described in the grant application kit PHS Form 6246-4, which is available at https://grants.nih.gov/grants/funding/sttr2/index.html . All instructions and information in these documents also apply to applications submitted in response to this PA. Eligibility requirements for applications for Phase I SBIR grants (R43) are described in the Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration for SBIR Grant Applications (PHS 99-2). This Solicitation is available at https://grants.nih.gov/grants/funding/sbir1/toc.htm . Eligibility requirements for applications for Phase II SBIR grants (R44) are described in the grant application kit PHS Form 6246-2, which is available at https://grants.nih.gov/grants/funding/sbir2/index.htm . All instructions and information in these document also apply to applications submitted in response to this PA. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Responsibility for the planning, direction, and execution of the proposed research will be solely that of the applicant. Phase II SBIR and STTR applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR or STTR awards. The previously funded Phase I award need not have been awarded under this PA but the Phase II proposal must be a logical extension of the Phase I research. The Fast Track initiative (described in the SBIR and STTR Omnibus Solicitations) is designed to expedite the decision and award of SBIR and STTR Phase II funding for scientifically meritorious applications for projects that have a high potential for commercialization. Fast Track is a parallel review option available to those small business concerns whose applications satisfy additional criteria which enhance the probability of the project's commercial success. Those criteria are described in the Omnibus Solicitations. Applications that do not meet these criteria may be redirected for review through the standard review procedures described in the Omnibus Solicitations. Fast Track offers two major advantages: 1) concurrent submission and peer review of both Phase I and Phase II projects and 2) minimal or no funding gap between Phase I and Phase II. C. RESEARCH CAREER DEVELOPMENT AWARDS (K08, K23, K24) ELIGIBILITY Eligibility requirements for applications for Mentored Clinical Scientist Development Awards (K08) are described at https://grants.nih.gov/grants/guide/pa-files/PA-00-003.html . Eligibility requirements for applications for Mentored Patient-Oriented Research Career Development Awards (K23) are described at https://grants.nih.gov/grants/guide/pa-files/PA-00-004.html . And eligibility requirements for Midcareer Investigator Awards in Patient-Oriented Research (K24) are described at https://grants.nih.gov/grants/guide/pa-files/PA-00-005.html. NEI-specific supplemental information regarding these awards is available at http://www.nei.nih.gov/funding/NEIFM.htm . MECHANISM OF SUPPORT Responsibility for the planning, direction, and execution of the proposed research will be solely that of the candidate on behalf of the applicant organization. The total project period for an application submitted in response to this PA may be three, four, or five years. K08 and K23 career development awards are not renewable; the K24 award may be renewable for one additional five-year period if the candidate still meets the stated requirements. Candidates for career development awards should consult the NIH website for details: https://grants.nih.gov/training/careerdevelopmentawards.htm. RESEARCH OBJECTIVES Background Retinal degenerative diseases including retinitis pigmentosa (RP), Usher's syndrome, macular degeneration, and other rare disease forms affect over six million Americans. These blinding diseases affect persons of all ages and races. During the past decade, dramatic progress had been made in understanding many aspects of retinal degenerative diseases through studies of the structure, function, and metabolism of the normal retina and retinal pigment epithelium (RPE). In particular, the application of molecular techniques has allowed the identification of many genes responsible for a number of retinal degenerative diseases. The identified human gene mutation has allowed scientists to identify or create animal models with retinal degeneration. In addition, genes responsible for retinal degeneration in naturally-arising RD and RDS mouse strains are now known to be homologous to genes associated with retinal degenerative diseases in humans. All these animal models are the subject of intensive study to determine the pathophysiological mechanisms by which gene defects lead to photoreceptor degeneration. New knowledge about molecular defects underlying inherited blindness in animals and humans has shown that retinal degenerations are a highly heterogeneous group of diseases. Yet, studies from many laboratories have defined several promising new therapeutic approaches. Progress has been made in gene targeting approaches with the development of a new generation of vectors, which may be more effective and safe. In addition, several laboratories have shown slowing of photoreceptor degeneration in several animal models following therapy with neuronal survival factors or growth factors. Retinal transplantation has seen some advances, but there is a need for better understanding of the immunological issues related to transplantation into the subretinal space. Scientists are also exploring other approaches that may be potentially useful in treatment of retinal degenerative diseases. These include studies of anti-apoptotic proteins as potential therapeutic agents as well as ribozymes, antisense nucleic acids, and triplex-forming oligonucleotides. Identifying the underlying molecular and cellular defects in retinal degenerative diseases will be critical to the development of effective therapies to slow or halt the degenerative process. Research Topics It is the intent of this solicitation to invite applications from investigators with diverse scientific interests to enhance our understanding of the etiology and pathogenesis of retinal degenerative diseases, and to develop innovative strategies to prevent, treat, or cure these blinding diseases. It is hoped that applicants will capitalize on recent and emerging research progress and research tools. Broad areas of interest related to the goals of this PA include, but are not limited to: o Identify novel causes of retinal degenerative diseases; examine the cellular and molecular mechanisms whereby gene defects cause retinal degenerations. o Further delineate the pathophysiology of human retinal degenerative disease o Identify additional genes and modifiers involved in retinal degenerative diseases. o Develop and critically evaluate potential therapeutic strategies, such as gene transfer, tissue and cell transplantation, growth factor therapy, and pharmacological intervention. Identify innovative therapeutic interventions and gene-targeted approaches to slow or prevent the progression of retinal degeneration. o Identify retinal genes and expressed sequence tags (ESTs) that are unique to the visual system or that have hall marks of candidates for retinal degenerative diseases. o Understand the normal function of the retina and RPE and apply this knowledge to the treatment, prevention, and diagnosis of retinal degenerative diseases. o Identify genes, pathways, and factors important for retina development, especially those that may be involved in controlling cell fate determination and differentiation. o Investigate the regenerative capacity of the retina. o Improve neuroprotective strategies that could prevent retinal cell death, promote survival, or stimulate regeneration. o Develop improved methods for clinical diagnosis of retinal degenerative diseases and for monitoring progression of the disease and treatment effectiveness. Information regarding NEI programmatic interest in retinal degenerative diseases is available in NEI's publication, Vision Research--A National Plan: 1999-2003, which is located at http://www.nei.nih.gov/resources/strategicplans/plan.htm. FFB Mission Statement: The mission of the FFB is to discover the causes, treatments, preventions, and cures for retinitis pigmentosa, macular degeneration, Usher's syndrome, and other related retinal degenerative diseases. More information regarding the Foundation and its programmatic interests can be found at http://www.blindness.org. SPECIAL REQUIREMENTS The NEI and FFB plan to sponsor periodic meetings to facilitate exchange of information among investigators funded as a result of this initiative and to foster cooperation and collaborative efforts among investigators. For this purpose, requests for travel funds for a one-day meeting each year in Bethesda, Maryland, should be included in the budget. In order for an application to be considered for funding by the FFB, the applicant must submit a brief letter of authorization, co-signed by the Principal Investigator and the official signing for the applicant institution, authorizing the NEI to release the application, the summary statement and all related materials to the FFB. These materials will be shared with the FFB when available. Applications without such authorization will not be considered for funding by the FFB. Dissemination of Research Resources It is anticipated that research developed under this PA will generate reagents such as cDNA libraries, ESTs, clones, and sequences. The sharing of such materials, data, and software in a timely manner has been an essential element in the rapid progress that has been made in biomedical research. Research materials and results produced in projects funded by this PA will be distributed to scientific investigators in the wider research community, and will augment existing resources. PHS policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community, see https://grants.nih.gov/grants/guide/notice-files/not96-184.html . The NIH is interested in ensuring that the research resources developed through this PA become readily available to the research community for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public. For this reason, NIH is concerned that patent applications for a large number of ESTs, cDNAs, and other research resources might have a chilling effect on the future development of products and information that may improve the public health. At the same time, NIH recognizes the rights of grantees to elect and retain title to subject inventions developed under Federal funding under the provision of the Bayh-Dole Act. Indeed for inventions developed in its intramural program, NIH does file patent applications, in accord with a set of policies described at http://ott.od.nih.gov/phspat_policy.html. To address the joint interests of the government in the availability of, and access to, the results of publicly-funded research and in the opportunity for economic development based on these results, NIH requires applicants who respond to this PA to propose detailed plans for sharing the research resources and data generated through the grant, if applicable. For this purpose, it is the opinion of the NIH that dissemination of such developments via individual laboratory web sites is not sufficient, as it would force interested investigators to have to search several different data collections to make use of the results of this initiative. Specifically, applicants should (1) propose a plan for placing clones, ESTs, and other research resources in common, public databases and repositories, and (2) address if or how they plan to exercise their intellectual property rights, including options to for-profit research sponsors, that might be associated with clones, ESTs, and cDNA libraries that may be generated. It is expected that the investigator's data sharing plan include all elements of the guidelines developed by the NIH and the Department of Energy to address the special needs of human genome research. These guidelines call for material and information to be made available within six months of the time the data or materials are collected, and are available at http://www.nhgri.nih.gov/Grant_info/Funding/Statements/data_release.html Adherence with this time frame is highly desirable. More rapid sharing is encouraged. Requests for exemptions or extensions will require compelling justification and will be fully evaluated by program staff. Applicants are also reminded that the grantee institution is required to disclose each subject invention to the Federal agency providing research funds within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. The NEI reserves the right to monitor grantee activity in this area to ascertain if patents on large numbers of research resources related to this PA are being filed. Where appropriate, grantees may work with the private sector to make unique resources available to the wider biomedical research community at a reasonable costs. Applicants may request funds to defray the costs of sharing resources, with adequate justification. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide to Grants and Contracts, March 18, 1994, available on the web at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that children (individuals under the age of 21) must be included in all research involving human subjects conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html . Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES A. RESEARCH PROJECT GRANTS (R01) Applications for R01 grants are to be submitted on the grant application form PHS 398 (rev. 4/98). All submissions will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. 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 program staff contact listed at the end of this program announcement before submitting the application. Furthermore, the applicant must obtain agreement from NEI program staff that the NEI will accept the application for consideration of award. Finally, the applicant must identify, in a cover letter sent with the application, the program staff member who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998, which is available at https://grants.nih.gov/grants/guide/notice-files/not98-030.html The title and number of this Program Announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 Direct Costs in any year must follow the traditional PHS 398 application instructions.) The Total Direct Costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) Costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form Page. o PERSONNEL - List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. o CONSORTIUM/CONTRACTUAL COSTS - Provide an estimate of Total Costs (Direct plus F&A Costs) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and their role on the project. Indicate whether the collaborating institution is foreign or domestic. The Total Cost for a consortium/contractual arrangement is included in the overall requested Modular Direct Cost amount. Include the Letter of Intent to establish a consortium. o Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years; - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A Costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) B. SMALL BUSINESS GRANTS (R41, R42, R43, R44) Applications for SBIR or STTR Phase I, Phase II, or Fast Track grants are to be submitted on the grant application forms in the Omnibus Solicitations described above. Applications will be accepted on or before the receipt dates indicated in the application kits. The Omnibus Solicitations are available on the Internet at https://grants.nih.gov/grants/funding/sbir.htm . A limited number of hard copies of the Omnibus Solicitation are available from: PHS SBIR/STTR Solicitation Office, 13685 Baltimore Avenue, Laurel, MD 20707-5096, telephone 301/206-9385, FAX 301/206-9722, Email a2y@cu.nih.gov . Submit a signed, typewritten original of the application, including the checklist, and two signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) C. RESEARCH CAREER DEVELOPMENT AWARDS (K08, K23, K24) Potential candidates are strongly encouraged to contact an NEI staff person listed under INQUIRIES. Such contact should occur early in the planning phase of application preparation. Such contact will help ensure that applications are responsive to the goals and policies of the NEI. Applicants who will be using a General Clinical Research Center (GCRC) are requested to include a letter from either the GCRC Program Director or the Principal Investigator with the application. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) using the instructions in Section IV and the NEI-specific instructions at http://www.nei.nih.gov/funding/NEIFM.htm as appropriate. Applications will be accepted on or before the receipt dates indicated in the application kit. Forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Phone (301) 435-480-0525, Email: grantsinfo@nih.gov. Forms are also available on the NIH website at https://grants.nih.gov/grants/forms.htm. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. All applications will receive a second level review by the appropriate National Advisory Council. Review Criteria A. RESEARCH PROJECT GRANTS (R01) The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach: Are the conceptual framework, design, methods, and analyzes adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator: is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? B. SMALL BUSINESS GRANTS (R41, R42, R43, R44) SBIR and STTR application review criteria are described in the Omnibus Solicitations. Phase I applications should specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. Failure to provide clear, measurable goals may be sufficient reason for the study section to judge the application non-competitive. C. RESEARCH CAREER DEVELOPMENT AWARDS (K08, K23, K24) Mentored Clinical Scientist Development Award (K08) applications will be reviewed according to the criteria described in https://grants.nih.gov/grants/guide/pa-files/PA-00-003.html. Mentored Patient-Oriented Research Career Development Award (K23) applications will be reviewed according to criteria described in https://grants.nih.gov/grants/guide/pa-files/PA-00-004.html. Midcareer Investigator Award in Patient-Oriented Research (K24) applications will be reviewed according to criteria described in https://grants.nih.gov/grants/guide/pa-files/PA-00-005.html. In addition to the above review criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, adequacy of plans to make research resources developed during this project publicly available in a timely manner, cost effectiveness of the proposed strategy, promise of the proposed program to accomplish the goals of this PA, and availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Peter A. Dudley, Ph.D. or Maria Y. Giovanni, Ph.D. Division of Extramural Research National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-0484 FAX: (301) 402-0528 Email: pad@nei.nih.gov or giovanni@nei.nih.gov Santa J. Tumminia, Ph.D. Science Programs Manager The Foundation Fighting Blindness Executive Plaza I, Suite 800 11350 McCormick Rd. Hunt Valley, MD 21031-1014 Telephone: (410) 785-1414 FAX: (410) 771-9470 Email: stumminia@blindness.org Direct inquiries regarding fiscal matters to: William W. Darby Grants Management Officer Grants Management Branch National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5884 FAX: (301) 496-9997 Email: wwd@nei.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.867, Vision Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, a portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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