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 
http://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 
http://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 
http://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 http://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 http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, 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: 
http://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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://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 
http://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 
http://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 
http://grants.nih.gov/grants/stem_cells.htm and at 
http://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 
http://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 
http://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.

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