INNOVATIVE STRATEGIES AND ASSISTIVE TECHNOLOGIES FOR ENHANCED VISUAL FUNCTION (SBIR/STTR AWARDS) RELEASE DATE: January 14, 2002 RFA: RFA-EY-02-002 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Eye Institute (http://www.nei.nih.gov) APPLICATION RECEIPT DATES: March 26, 2002; July 26, 2002; and March 26, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Where to send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA This announcement is to encourage small businesses to participate in research on assistive technology that facilitates the rehabilitation of individuals with disabilities resulting from low vision and blindness. The goals of this program are intended in the broadest possible context to improve mobility and/or accomplishment of every day tasks This may involve improving or enhancing residual vision and/or substituting for visual information through new devices, technologies, delivery systems, environmental modifications, behavioral interventions, and/or training techniques. This initiative is designed to expedite the transition of innovative technology and development into practical applications. The development of new technologies and the modifications of existing technologies may require a multidisciplinary approach. Therefore, investigators responding to this initiative may be drawn from such fields as neuroscience, biology, chemistry, engineering, psychology, education, rehabilitation, and health services research. RESEARCH OBJECTIVES Background Vision impairment is defined as any chronic visual deficit that compromises the performance and enjoyment of the activities of daily living and is not correctable by ordinary spectacles or contact lenses. Almost 14 million Americans suffer from some form of visual impairment. Difficulties with daily activities can lead to conditions that seriously reduce quality of life, including depression, social isolation, educational problems, and employment challenges. All of these underscore the critical importance of research designed to minimize these difficulties among the visually impaired. Over the past decade, increased scientific discoveries in the biomedical and engineering sciences have provided an opportunity for developing a wide range of new assistive technologies. This RFA encourages applicants to take advantage of the SBIR/STTR program mechanisms for multidisciplinary rehabilitation research projects that develop technology to enhance the function of individuals with low vision and blindness. The initiative is intended to be broad, and open to all relevant research ideas. Understanding the effects of visual impairment on everyday task performance requires a consideration of cognitive and other sensory influences. Thus, responses to this initiative may include the development of appropriate rehabilitative and evaluation strategies and assessment tools, as well as assistive technologies and devices. Summary and Scope Examples of research that would be considered responsive to this solicitation are listed below. This is not meant to be a delimiting, exhaustive, or exclusionary list: o Develop innovative assistive devices and techniques to maximize residual vision. o Develop improved optical and/or electro-optical devices for the visually impaired. o Develop technologies to assess the visual processing capabilities of the visually impaired. o Develop new technology to improve guidance systems for the visually impaired. o Develop environmental designs and modifications that enhance independence among the visually impaired. o Develop assessment tools that allow clinicians to properly identify and evaluate problems in performing daily visual tasks. o Develop improved rehabilitation outcome measures. o Develop improved training strategies for eye health professionals on the appropriate selection and use of assistive technologies. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) SBIR/STTR award and Fast Track SBIR/STTR award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA must be read in conjunction with the current calendar year Omnibus Solicitation at https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. Phase I applications which are responsive to this RFA will be funded as Phase I SBIR Grants (R43) or Phase I STTR Grants (R41). Phase II SBIR (R44) or STTR (R42) applications will be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. Such Phase II applications must be responsive to this RFA and logical extensions of the funded Phase I research. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE The NEI intends to commit approximately $3.0 million in FY 2002 and in FY 2003 to fund approximately 20 new and/or competitive continuation grants in response to this RFA. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The length of time and the cost of research involving technology development research projects often exceed those normally awarded for SBIR/STTR grants. Therefore, the NEI will accept Phase I applications with a project period of up to two years and a budget, including fixed fees, not to exceed $250,000 total cost per year. Similarly, Phase II applications may request a project period of up to three years and a budget, including fixed fees, not to exceed $450,000 total cost per year. Fast Track applications may request up to five years and annual total costs, including fixed fees, not to exceed $250,000 for the first two years and $450,000 for the last three years. SBIR/STTR guidelines limit the total amount of all consultant and contractual costs requested for Phase I and Phase II projects. However, this RFA will consider requests for those consultant and contractual costs necessary to support the proposed studies. Although the financial plans of the NEI provides support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. This RFA is a one-time solicitation with three separate receipt dates, March 26, 2002; July 26, 2002; and March 26, 2003. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award dates are September 30, 2002; April 1, 2003; and September 30, 2003, respectively. ELIGIBLE INSTITUTIONS Eligibility requirements for SBIR and STTR are described in the NIH Omnibus Solicitation for SBIR/STTR Grant Applications, which is available on the internet at https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Ralph J. Helmsen, 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) 496-5301 FAX: (301) 402-0528 Email: rh27v@nih.gov o Direct your questions about peer review issues to: Samuel C. Rawlings, Ph.D. Chief, Scientific Review Branch National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5561 FAX: (301) 402-0528 Email: rawlings@nei.nih.gov o Direct your questions about financial/grants management matters to: William W. Darby Grants Management Officer 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 SUBMITTING AN APPLICATION o OMNIBUS SOLICITATIONS for the SBIR/STTR programs are available electronically at https://grants.nih.gov/grants/funding/sbir.htm. Hard copies are not available. Applicants should follow the instructions for Phase I, Phase II, or Fast Track submissions with the modifications as noted in this RFA. For Phase I applications, applicants are strongly encouraged to highlight the innovation of their proposed research and to clearly state the milestones that will be used to demonstrate feasibility. For Phase II applications, the demonstration of feasibility accomplished in Phase I should be clearly identified. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. o USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. o SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, one additional copy of the application must be sent to: Samuel C. Rawlings, Ph.D. Chief, Scientific Review Branch National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5561 FAX: (301) 402-0528 Email: rawlings@nei.nih.gov o APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NEI. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NEI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which applications will be discussed and assigned a priority score o Receive a second level review by the National Advisory Eye Council REVIEW CRITERIA Review criteria are described in the OMNIBUS SOLICITATION at the website listed above. The Phase I application 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. o ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: (1) PROTECTIONS: 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. (2) INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) (3) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE #1 #2 #3 Receipt Date: March 26, 2002 July 26, 2002 March 26, 2003 Review Date: July, 2002 Nov, 2002 July, 2003 Council Review: Sept, 2002 Jan, 2003 Sept, 2003 Anticipated Start Date: Sept 30, 2002 April 1, 2003 Sept 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS o INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new Office of Management and Budget (OMB) standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. o INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1). 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 is available at https://grants.nih.gov/grants/funding/children/children.htm. o REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. o HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research in the Description on page 2 of the application. Applications that do not provide this information will be returned without review. o PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The OMB Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. o URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. o HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. o AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.387, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the PHS Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the 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, any 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.
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |