TELEHEALTH TECHNOLOGIES DEVELOPMENT (SBIR/STTR)
 
RELEASE DATE:  November 18, 2002
 
PA NUMBER: PA-03-030

EXPIRATION DATE: January 1, 2004 unless reissued.
 
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 (http://www.nibib.nih.gov)
 
THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
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 Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
invites grant applications for Small Business Innovation Research (SBIR) and 
Small Business Technology Transfer (STTR) awards to support design and 
development of novel telehealth instrumentation or technologies that can be 
applied to a broad spectrum of disorders and diseases.  There is also a 
parallel Request for Applications (RFA) announcement on this topic RFA-EB-03-
005 (http://grants.nih.gov/grants/guide/rfa-files/RFA-EB-03-005.html).

Telehealth is defined by the Federal Communications Commission and by the 
DHHS Office of Health Promotion and Disease Prevention as "the use of 
communications technologies to provide and support health care at a distance.  
Examples include the use of communications to provide patient treatment, 
often via still images or video, and the exchange and distribution of public 
health information."  Issues amenable to technical solution arise in the 
diagnosis, treatment, and follow-up with a patient at a distance.  The 
technical feasibility of telehealth applications has been well demonstrated 
for several specific applications in the past.  The current need is to 
generalize remote access technology to be adaptable to a broad range of 
telehealth applications, to develop mechanisms in which the technology can be 
integrated seamlessly into the routine of the provider and the patient, and 
to develop technology for standardizing and incorporating state-of-the-art 
security protocols for verifying user identities and preserving patient 
confidentiality.

This Program Announcement (PA) is intended to support an integrated approach 
on the part of biomedical engineers or imaging scientists with medical care 
professionals.

RESEARCH OBJECTIVES

The main objective of broadening the usability issues in telehealth cover but 
are not limited to the following application areas:

One type of telehealth, store and forward, involves image-based consults, 
where medical diagnosis or treatment of a patient in a remote clinical care 
setting is accomplished through the forwarding of the locally-obtained 
medical images to the pertinent specialist.  Examples include teleradiology, 
telepathology, and teledermatology.  To facilitate this practice, there is a 
need for specialized hardware and software for image compression, storage, 
transmission, and display.  The research objective is the development and 
validation of the specialized hardware or software. In addition, the quality 
of the workstation monitors at the receiving end is important.  In this case, 
the research objective can range from the determination of quantitative 
measures of the necessary workstation image quality, or technical 
improvements in workstation monitors.

For real-time but not necessarily image-based examinations with a distant 
health-care consultant, additional considerations come in to play.  The 
research objective is to design and develop the needed easy-to-use peripheral 
devices that can aid in a remote interactive examination.

Another type of telehealth takes place in a non-clinical setting.  Home-based 
health care using physiological monitoring devices would benefit from 
development of low-cost, low-power biosensors, wireless technologies, and 
inexpensive interactive video for pre-operative or follow-up interactions 
with a health care provider. 

In mass casualty situations on-the-scene health professionals could do with 
hand-held or portable digital imaging and display devices. Additional areas 
in need of development are wearable patient monitors, which are lightweight 
and non-invasive, long-life batteries, and telemetry hardware and software. 
 
The application should make clear that the proposed research is 
scientifically sound, the qualifications of the investigators are 
appropriate, and the resources available to the investigators are adequate.  
Applications from groups interested in developing suitable novel approaches 
are encouraged.  It is expected that this research will require expertise 
from a variety of disciplines, including engineering, computer science, 
physics, mathematics, and medicine.

MECHANISM OF SUPPORT
 
This PA will use the NIH Small Business Innovation Research (SBIR) and Small 
Business Technology Transfer (STTR) award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.

Applications can be submitted for support as Phase I STTR (R41) or Phase I 
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44)grants; or under 
the SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus 
Solicitation.  Phase II applications in response to this PA will only be 
accepted as competing continuations of previously funded NIH Phase I SBIR/STTR 
awards.  The Phase II proposal must be a logical extension of the Phase I 
research.

Information on the FAST-TRACK process and the SBIR/STTR Omnibus Solicitation 
is available at http://grants.nih.gov/grants/funding/sbir.htm.

ELIGIBILITY REQUIREMENTS
 
Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. 
Any small business concern, independently owned and operated by United States 
citizens or lawfully admitted permanent resident aliens, which is located in 
the United States, has 500 or fewer employees and is organized for profit, may 
apply.

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 PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Mary S Pastel, ScD
Division of Biomedical Imaging
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
Democracy Two, Suite 200
Bethesda, MD  20892-5469
Telephone:  (301) 451-4781
Email: [email protected]

o Direct your questions about financial or grants management matters to:

Mr. Nick Mitrano
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
Democracy Two, Suite 900
Bethesda, MD  20892-5469
Telephone:  (301) 451-4782
Email: [email protected]

SUBMITTING AN APPLICATION

Detailed information regarding submitting SBIR grant applications is available 
on the NIH website at 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf

SBIR/STTR applicants must use the PHS 398 instructions and forms for all Phase 
I and Phase II applications. See http://grants.nih.gov/grants/forms.htm for 
links to the PHS 398 Application Instructions and new Fillable Forms. 
IMPORTANT NOTE: Applicants should refer to Chapter VI 
http://grants.nih.gov/grants/funding/phs398/instructions2/
p1_preparing_SBIR_STTR_app.htm of the PHS 398 
instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html)prior to 
preparing an SBIR or STTR application. Please note that Phase I applications 
with budgets of $100,000 or less total costs should use the Modular Budget 
Page and omit Form Pages 4 and 5. See 
http://grants.nih.gov/grants/funding/phs398/instructions2/
p1_SBIRSTTR_general_instructions.htm. For 
answers to frequently asked questions about using the new fillable forms, see 
FAQs: Revised PHS 398 and PHS 2590 Forms and Instructions at 
http://grants.nih.gov/grants/forms_faq.pdf.

For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email:[email protected].
 
SENDING AN APPLICATION TO THE NIH: 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)
  
APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  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 PA 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.

Please Note: As of November 27, 2001, all applications and other deliveries 
to the Center for Scientific Review must come via courier delivery or the 
USPS.  Applications delivered by individuals to the Center for Scientific 
Review will no longer be accepted.  For additional information, see the NIH 
Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

REVIEW CONSIDERATIONS 
 
Upon receipt, applications will be reviewed for completeness and 
responsiveness by the CSR.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration. 

Applications that are complete and responsive to the PA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened 
by the CSR 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 only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council for 
Biomedical Imaging and Bioengineering.   
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you 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 the proposed project have commercial potential to 
lead to a marketable product or process? Does this study address an important 
problem? What may be the anticipated commercial and societal benefits of the 
proposed activity? If the aims of the application are achieved, how will 
scientific knowledge be advanced? Does the proposal lead to enabling 
technologies (e.g., instrumentation, software) for further discoveries?     
Will the technology have a competitive advantage over existing/alternate 
technologies that can meet the market needs?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Is the proposed plan a sound approach for establishing technical 
and commercial feasibility? Do you acknowledge potential problem areas and 
consider alternative tactics? Are the milestones and evaluation procedures 
appropriate?

(3) INNOVATION:  Does your project challenge existing paradigms or employ 
novel technologies, approaches or methodologies? Are the aims original and 
innovative? 

(4) INVESTIGATOR: Is the Principal Investigator capable of coordinating and 
managing the proposed SBIR/STTR? Is the work proposed appropriate to the 
experience level of the Principal Investigator and other researchers, 
including consultants and subcontractors(if any)? Are the relationships of 
the key personnel to the small business and to other institutions appropriate 
for the work proposed?

(5) ENVIRONMENT:  Is there sufficient access to resources (e.g., equipment, 
facilities)? Does the scientific and technological environment in which your 
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?

In accordance with NIH policy, all applications will also be reviewed with 
respect to the following:

o 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.

o 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)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

Phase II Applications 

In addition to the above criteria, to what degree was progress toward the 
Phase I objectives met and feasibility demonstrated in providing a solid 
foundation for the proposed Phase II activity? 

Phase I/Phase II Fast-Track Applications 

For Phase I/Phase II Fast-Track applications, the following additional 
criteria will be applied: Does the Phase I application specify clear, 
measurable goals (milestones) that should be achieved prior to initiating 
Phase II? Did the applicant submit a concise Product Development Plan that 
adequately addresses the areas described in the Omnibus Solicitation? To what 
extent was the applicant able to obtain letters of interest, additional 
funding commitments, and/or resources from the private sector or non-SBIR/STTR 
funding sources that would enhance the likelihood for commercialization? 

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.

AWARD CRITERIA

Applications will compete for available funds with all other recommended SBIR 
and STTR applications.  Funding decisions for Phase I or Phase II applications 
will be based on quality of the proposed project as determined by peer review, 
availability of funds, and relevance to program priorities.  

FAST-TRACK Phase II applications may be funded following submission of the 
Phase I progress report and other documents necessary for continuation.  Phase 
II applications will be selected for funding based on the initial priority 
score, NIBIB's assessment of the Phase I progress and determination that Phase 
I goals were achieved, the project's potential for commercial success, and the 
availability of funds.

REQUIRED FEDERAL CITATIONS 

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 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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., 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) 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

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.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (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 PA 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.

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.

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 PAR 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.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.286 and 93.287 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 Public Health Service 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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