LOW-COST MEDICAL IMAGING DEVICES
 
RELEASE DATE:  January 6, 2003
 
RFA:  EB-03-006
 
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib1.nih.gov/)
 
LETTER OF INTENT RECEIPT DATE:  February 17, 2003

APPLICATION RECEIPT DATE:  March 14, 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 Special Requirements
o Where to Send Inquiries
o Letter of Intent
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

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
invites applications for NIH Research Project Grant (R01) awards to 
support interdisciplinary basic research or Exploratory/Developmental 
Research (R21) awards to support novel investigations for reduced cost 
imaging devices that can be broadly applied to research on biological 
or disease processes. 

The primary purpose of this Request for Applications (RFA) is to 
support research and development of low-cost imaging devices used for 
detection, screening, diagnosis, and treatment of human disease and 
injury. Medical imaging is critical for quality health care, yet 
remains widely unavailable to many patients in small hospitals, rural 
communities and underdeveloped nations. Thus, this initiative is 
directed at the invention and development of low-cost imaging devices 
for more efficient application and worldwide use of medical imaging 
devices. Applications are expected to describe how the proposed 
technology or research will reduce the cost of medical imaging, and the 
expected magnitude of the cost-reduction.

Most current imaging devices used for diagnosis and treatment planning 
are expensive and unavailable to large segments of humanity, therefore 
the primary motivation of this initiative is to stimulate research that 
will lead to lower cost imaging devices. Development of inexpensive, 
innovative, high-resolution imaging devices is needed, with particular 
emphasis on early detection and efficient treatment of disease and 
injury. Furthermore, cost reductions in high technology imaging devices 
will result in reduced health care costs.  

The integration of new, low-cost improvements of existing and emerging 
imaging technologies is also sought.  For example, cost reductions are 
sought for detectors, sensors or other essential components of imaging 
devices. Thus, new technologies are needed that enhance, augment, and 
improve devices for biomedical imaging while reducing the overall cost 
of imaging procedures. Associated improvements in imaging technology 
may include, but are not limited to: increasing the speed of data 
acquisition, enabling real-time imaging, improving the efficiency of 
information processing, or otherwise reduce the cost of acquiring and 
processing biomedical images. The intent of these kinds of improvements 
would be the reduction of imaging time and processing time, while 
maintaining image quality. 

In some cases it may be desirable to sacrifice image quality to 
significantly reduce the cost of an imaging device.  However, useful 
imaging devices for detection, diagnosis and treatment remain the goal, 
and it is left to the investigator to demonstrate the cost/benefit of 
such devices. In other words, the trade-off between significant cost 
reduction and loss of image quality must be described, while the 
benefit of the imaging device to human health must be clearly defined.  

In summary, this initiative will facilitate the development of low-
cost, generic, in vivo imaging technologies applicable to multiple 
organs and diseases. This RFA is intended to stimulate (a) development 
of low-cost image technologies, including high risk/high gain research 
on innovative technologies and (b) development useful biomedical 
imaging systems and methods for more cost effective health care.  

RESEARCH OBJECTIVES

The need to support research and development of low-cost imaging devices 
has been identified at scientific meetings and NIH workshops on 
biomedical imaging including the IEEE Biomedical Imaging Conference, 
2002 the Image Guided Interventions Workshop, September 2002 and the 
NIBIB Workshop on Future Research Directions, December 2002. As a part 
of its global health initiative under the Department of Health and 
Human Services (DHHS), the need for imaging technologies in 
underdeveloped nations was recently mentioned in a Federal Agency 
report. This RFA contributes to the NIBIB mission and to the broad NIH 
initiative to reduce health disparities among nations by strengthening 
medical technologies and research infrastructure in developing 
countries.  
 
Technological and scientific and needs that will be addressed include 
1) the need for imaging devices that are unavailable to large segments 
of humanity, particularly in underdeveloped nations; 2) the need to 
reduce the rising costs of imaging technologies used in the health care 
system of the United States; and 3) the need for the invention and 
development of low-cost imaging devices that will make imaging 
technologies widely available, particularly in remote or rural 
communities and small hospitals that do not have ready access to these 
technologies.  

The following research areas are examples of appropriate topics for 
applications in response to this RFA. This list is meant to be 
representative and is not all-inclusive:

o   Expansion of less costly imaging techniques into broader 
applications that currently can only be done with more expensive 
technologies. It will be the responsibility of the investigator to 
demonstrate the cost/benefit of their technique.  Cost/benefit 
should be demonstrated with measures of performance that demonstrate 
the instrument can meet the design objectives.

o   Imaging device components that reduce the cost of existing imaging 
devices (e.g. MRI, CT, PET, ultrasound, or optical devices). For 
example, development of high temperature superconductors for MRI 
magnets or cost/benefit improvements in RF coils or pulse gradient 
systems.

o   New imaging devices that are low-cost and provide novel methods for 
the diagnosis or treatment of disease or injury. 

o   New imaging technologies that replace extant imaging devices used 
for diagnosis and treatment. For example, new optical imaging 
devices that replace tomographic or MR imaging used for specific 
diagnostic tests or interventions.

o   More efficient detectors.

o   New approaches to collimation that reduce imaging costs.

o   Simple, inexpensive imaging devices such as portable ultrasound 
machines or radiographic devices that could be cheaply and widely 
distributed.

o   Novel imaging devices that improve existing technologies and might 
be used to replace alternative, high-cost imaging devices, yet 
achieve the same result.  For example, projection radiography used 
in place of computed tomography for volumetric imaging. 

o   Reconstruction methods that improve diagnostic capabilities of 
existing low-cost devices.  For example, 3D reconstructions from 
ultrasound or optical imaging.
 
MECHANISM OF SUPPORT
 
This RFA will use the NIH R01 (Research Project Grant) and R21 
(Exploratory/Developmental Grant) award mechanisms.  As an applicant 
you will be solely responsible for planning, directing, and executing 
the proposed project.  This RFA is a one-time solicitation.  Future 
unsolicited, competing-continuation applications based on this project 
will compete with all investigator-initiated applications and will be 
reviewed according to the customary peer review procedures.  The 
anticipated award date is September 2003.

The R01 mechanism is recommended for applications that emphasize basic 
discovery or cross-cutting research that addresses specific aspects of 
reducing costs of imaging devices.   Research periods associated with 
the R01 proposals are limited to five years.   

The R21 Exploratory/Developmental Award supports exploratory or 
developmental research aimed at proof-of-principle for high-risk 
projects where very little or no preliminary data is available.  An R21 
application can be for up to two years with a maximum budget request of 
$275,000 direct costs for the 2-year period and a maximum page limit of 
15 pages.  R21 applications are not renewable.  Investigators are 
encouraged to use data generated from the R21 application to apply for 
further funding through the R01 mechanism (or other appropriate 
mechanisms).

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 NIBIB intends to commit approximately $5,000,000 in FY 2003 to fund 
12 to 15 new and/or competitive continuation grants in response to this 
RFA. For R01s, an applicant may request a project period of up to 5 
years.  There is no cap on the budget.  For R21s, an applicant may 
request a project period of up to 2 years and a budget for direct costs 
of up to $275,000 for the 2-year period. 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.

Although the financial plans of the NIBIB provide 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. 

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
 
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.   
 
SPECIAL REQUIREMENTS 

Restrictions and Exclusions: Development of animal imaging devices and 
complementary devices such as contrast agents, molecular probes, 
capsules, etc., are not part of the current initiative and would be 
considered non-responsive to this RFA; however, these areas may be 
covered by other related initiatives (e.g. small animal imaging, 
molecular imaging and bioengineering (BECON and other) initiatives).  

In addition, applications proposing to improve or invent imaging 
methodologies without reducing costs will also be deemed non-responsive 
to this RFA.

General Clinical Research Centers:  Applicants from institutions that 
have a General Clinical Research Center (GCRC) funded by the NIH 
National Center for Research Resources (NCRR) may wish to identify the 
GCRC as a resource for conducting the proposed research.  If so, a 
letter of agreement from either the GCRC program director or principal 
investigator should be included with the application.

Meetings:  Principal Investigators will be required to attend an annual 
meeting organized by NIBIB.  Please include travel to the Bethesda, MD 
area as part of the budget request.  
 
WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
these areas:  scientific/research and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Dr. John W. Haller
Health Scientist Administrator
Division of Biomedical Imaging
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Blvd. Suite 200
Bethesda, MD  20892-5477
Telephone:  301-451-4772
Fax:  301-480-4971
Email:  hallerj@mail.nih.gov

o Direct questions regarding financial or grants management matters to:

Ms. Lisa Moeller
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health/DHHS
6707 Democracy Blvd., Suite 900
Bethesda, MD  20892-5469
Telephone:  301-451-4782
Fax:  301-480-4974
Email:  moellerl@mail.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows staff to estimate the potential review workload 
and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

David T. George, Ph.D.
Chief, Office of Scientific Review 
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
Suite 920
6707 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 496-8633
Fax: (301) 480-0675
Email: georged1@mail.nih.gov
 
SUBMITTING AN APPLICATION

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.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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.
 
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 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.

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.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIBIB.  Incomplete applications will be returned to 
the applicant without further consideration.  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 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 your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  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 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

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

(4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT:  Does the scientific 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?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application 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 DATA SHARING:  The adequacy of the proposed plan to share data. 

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: February 17, 2003
Application Receipt Date: March 14, 2003
Peer Review Date: June/July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 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 

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 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.

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 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.

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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