RESEARCH AND DEVELOPMENT OF SYSTEMS AND METHODS FOR CELLULAR AND 
MOLECULAR IMAGING
 
RELEASE DATE:  November 20, 2002
 
RFA:  EB-03-003
 
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov)
National Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov)
 
LETTER OF INTENT RECEIPT DATE:  January 16, 2003

APPLICATION RECEIPT DATE:  February 13, 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) 
and the National Institute of General Medical Sciences (NIGMS) invite 
applications for NIH Research Project Grant (R01) awards to support 
interdisciplinary basic research or NIH Exploratory/Developmental Grant 
(R21) awards to support novel pilot or feasibility studies concerned 
with cellular and molecular imaging and/or spectroscopy that can be 
broadly applied to research on biological or disease processes.  

The primary focus of this Request for Applications (RFA) is in vivo 
cellular and molecular imaging and/or spectroscopy with human/clinical 
emphasis including devices, methods, and contrast agents.  The 
integration of these systems and methods with other 
imaging/spectroscopy modalities is also included as appropriate to 
support clinical investigations.  Consistent with the mission of the 
NIBIB, this initiative supports discovery or development of cross-
cutting technologies for cellular and molecular imaging and/or 
spectroscopy systems and methods that can be applied to research on 
multiple biological or disease processes.

Two small animal imaging initiatives recently issued aim to support 
novel interdisciplinary basic research and novel feasibility studies 
concerned with cellular and molecular imaging/spectroscopy focused on 
small animals.  Small animal imaging research using the R01 mechanism 
is supported by the RFA EB-03-002, "Systems and Methods for Small 
Animal Imaging"
(http://grants.nih.gov/grants/guide/rfa-files/RFA-EB-03-002.html),
and small business initiatives using the NIH SBIR/STTR 
mechanisms are supported by the Program Announcement PA-03-031, 
"Systems and Methods for Small Animal Imaging" 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-031.html). 

RESEARCH OBJECTIVES

The need to support discovery and development of biomedical imaging 
methods was identified at several NIH workshops and conferences on 
biomedical imaging including a June 25-26, 1999, symposium titled  
"Biomedical Imaging Symposium: Visualizing the Future of Biology and 
Medicine", which was coordinated by the NIH Bioengineering Consortium 
(BECON). Three scientific areas were addressed: (1) imaging at the 
cellular and molecular levels such as required for the early detection 
of disease; (2) imaging for the clinical diagnosis, staging, and 
recurrence of disease; and (3) imaging applied to therapeutic 
applications and monitoring for various disease processes.  The 
development of novel molecular imaging/spectroscopy methods that 
improve the spatial and temporal resolution, measurement sensitivity, 
and specificity for all three areas was identified as a critical need 
for this field. 

Molecular information is recognized as having a profound impact on 
approaches to diagnosing and treating diseases that have the potential 
of being redefined in terms of their characteristic genetic or 
molecular abnormalities.  New forms of therapy are possible to target 
the abnormal gene or phenotypic pathway, and methods are needed for 
image guidance to track response to these new therapeutic strategies.   
These advances are critically related to the development of molecular 
probes and contrast agents that can provide the associations to 
specific biological processes and thus improve the sensitivity and 
specificity of imaging methods for early disease detection and 
monitoring of therapeutic response.   Optimization of imaging systems 
and methods is required to realize the full potential of new contrast 
agents.

The support of fundamental discovery and technical development of 
imaging technologies before specific disease- or organ-oriented 
applications is mandatory.  These challenges can be accomplished 
effectively by multi-disciplinary teams from academia, national 
laboratories, and industry with expertise in the quantitative, 
computational, and biomedical sciences. 

Consistent with the recommendations of the BECON symposium and the 
mission of the NIBIB, the goals of this RFA are directed at basic 
research and/or development of in vivo cellular and molecular 
imaging/spectroscopy systems with a human/clinical focus.  Research 
areas of interest include methods and contrast agents that enhance 
spatial or temporal resolution, measurement sensitivity, and 
specificity as required for the detection, diagnosis, or measurement of 
treatment efficacy for different disease processes.   The scope of this 
RFA includes the integration of these systems and methods with 
anatomical or other functional imaging/spectroscopy methods to provide 
more effective tools for clinical use, the development of imaging or 
spectroscopy systems that have the flexibility to accommodate a variety 
of protocols for investigations of different diseases, and the 
development of platform-independent imaging methods for multi-center 
research.

These systems, methods and applications must be designed for eventual 
human/clinical use.  Development of in vitro imaging/spectroscopy 
systems and methods will be considered responsive to the RFA only if 
they are required to validate in vivo imaging/spectroscopy systems.  
Feasibility studies or proof-of-principle studies are appropriate to 
demonstrate the potential of the proposed systems and methods.

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

o Discovery and development of the next generation of in vivo cellular 
and molecular imaging and/or molecular spectroscopy systems and 
methods. The research scope may include new in vivo imaging and /or 
spectroscopy paradigms using tomographic, stationary, image-guided, or 
implanted systems and methods. 

o Development and integration of cellular and molecular imaging and/or 
spectroscopy systems with other imaging or spectroscopy systems and 
methods such as multi-modality imaging (e.g., to include tomographic 
and other localized stationary, image-guided, or implanted sensors). 
Development of sensors or multiple sensors that take advantage of 
microelectromechanical (MEMS) and nanoelectromechanical (NEMS) systems 
are included. 

o Discovery and development of novel contrast agents for in vivo 
molecular imaging and/or spectroscopy methods.   These may include 
molecular probes for biological processes such as gene expression at 
the level of transcription or translation, signal transduction for cell 
surface receptors, enzyme action or other metabolic processes, cell 
tracking, or blood flow or drug action that may impact the study of 
several disease processes.  NIGMS is specifically interested in the 
application and development of molecular imaging techniques to achieve 
a better understanding of cellular processes and structures in which 
the basic biology is the goal.

The National Center for Research Resources, while not a sponsor of this 
RFA, supports research and development similar to that solicited here.  
Potential applicants can visit the web site, 
http://www.ncrr.nih.gov/biomedical_tech.asp, or can contact Dr. 
Gregory Farber, farberg@ncrr.nih.gov, 
301-435-0755 for information about NCRR's programs and interests.
 
MECHANISM OF SUPPORT
 
This RFA will use 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 30, 2003.

The R01 mechanism is recommended for applications that emphasize basic 
discovery or cross-cutting research that addresses specific aspects of 
imaging systems, methods, or contrast agents.   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 no or very little preliminary data is available.  An R21 
application can be for up to two years with a maximum budget request of 
$150,000 direct costs per year and a maximum page limit of 10 pages.  
R21 applications are not renewable.  If sufficient results are 
generated during the term of the award, investigators are encouraged 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 and NIGMS intend to commit approximately $9,000,000 in FY 
2003 to fund 30 to 35 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 and a budget appropriate for the proposed 
research.  For R21 applications, an applicant may request a project 
period of up to 2 years and a budget for direct costs of up to $150,000 
per year.

Applications requesting up to $250,000 per year in direct costs must be 
submitted in a modular grant format.  Since the total costs for a 
subcontract or consortium are included in the direct cost request, one 
additional module of $25,000 may be requested for the facilities and 
administrative costs associated with third party agreements.  Under 
these guidelines, R21 applications requesting $150,000 may request 
$175,000 to cover the facilities and administrative costs described 
above.  A module requested for this purpose must be clearly identified 
in the budget justification section of the application, and will be 
restricted for this purpose only at the time of award.  

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 and NIGMS 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. At this 
time, it is not known if this RFA will be reissued.
 
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 

General Clinical Research Centers:  Applicants from institutions that 
have a General Clinical Research Center (GCRC) funded by the NIH 
National Center for Research Resources 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 
two areas:  scientific/research and financial or grants management 
issues:

o Direct questions about scientific/research issues to:

Brenda Korte, Ph.D.
Division of Biomedical Imaging
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
6707 Democracy Boulevard – Suite 200
Bethesda, MD 20892-5469
Telephone:  301-451-4774
Fax:  301-480-4973
Email:  kortebr@nibib.nih.gov

Catherine Lewis, Ph.D.
Chief, Biophysics Branch
Division of Cell Biology and Biophysics
National institute of General Medical Sciences
NIH/DHHS
45 Center Drive, Room 2AS-13C
Bethesda, MD 20892
Telephone:  301-594-0828
Fax:  301-480-2004
Email: lewisc@nigms.nih.gov

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

Ms. Florence Turska
Grants Management Officer
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
6707 Democracy Boulevard – Suite 900
Bethesda, MD  20892-5469
Telephone:  301-496-9314
Fax: 301-480-4974 
Email: turskaf@nibib.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, DHHS
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.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and for responsiveness by the 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 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 an appropriate advisory council or 
board.
 
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 R21 MECHANISM ONLY:  Since the R21 mechanism is intended to encourage 
exploratory/developmental research, proposals submitted as an R21 will 
be reviewed based on their high risk/high impact potential and whether 
or not the proposal is significantly distinct from those traditionally 
submitted through the R01 mechanism.  For example, R21 projects 
designed to produce incremental advances in knowledge will not be 
considered.

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: January 16, 2003
Application Receipt Date: February 13, 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.

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.  Applications that do not provide this 
information will be returned without review. 

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 & 93.287 (NIBIB) and 93.821 
(NIGMS) 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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