IN VIVO CELLULAR AND MOLECULAR IMAGING CENTERS (ICMICS)

RELEASE DATE:  February 27, 2004

PA NUMBER:  PAR-04-069 (see reissue PAR-06-406 and addendum NOT-CA-04-028)

EXPIRATION DATE:  July 22, 2005, unless reissued. 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.393 - 93.396 

LETTER OF INTENT RECEIPT DATE:  June 22, 2004; June 21, 2005 
APPLICATION RECEIPT DATE:  July 22, 2004; July 21, 2005 

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism of Support 
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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations

PURPOSE OF THIS PAR

The Cancer Imaging Program, Division of Cancer Diagnosis and Treatment of the 
National Cancer Institute (NCI), invites applications for new or competing 
P50 Research Center Grants for In Vivo Cellular and Molecular Imaging Centers 
(ICMICs).  This initiative is designed to capitalize on the extraordinary 
opportunity for molecular imaging to have an impact on the diagnosis and 
treatment of cancer patients non-invasively and quantitatively.  Molecular 
imaging technologies can provide valuable laboratory tools for the 
interrogation of biological pathways relevant to cancer, as well as to 
provide imaging agents and technologies that will be directly utilized in the 
clinic.  The 5-year P50 ICMIC grants described in this PAR are designed to 
bring together interdisciplinary scientific teams to lead the nation in 
cutting-edge cancer molecular imaging research with clinical relevance, 
provide unique core facilities to support oncology imaging research, provide 
flexibility to respond to exciting pilot research opportunities, and provide 
interdisciplinary career development opportunities for investigators new to 
the field of molecular cancer imaging.  The P50 mechanism will promote 
coordination, interrelationships and scientific synergy among the research 
components and resources, leading to a highly integrated imaging center.  

RESEARCH OBJECTIVES

The field of molecular imaging has made significant advances in recent years.  
The formation of multidisciplinary research teams has stimulated and 
streamlined cancer imaging research from inception to use in patient care.  
The P50 ICMIC structure allows mechanistic flexibility for each Institution 
to capitalize on its own unique scientific strengths, and to define the 
structure and research objectives that create the most synergistic and 
creative scientific interactions.  In general, an ICMIC will provide 
researchers with the following critical resources:

Special Features

1.  The ICMICs will provide an organizational structure specifically designed 
to facilitate multi-disciplinary interactions among investigators focused on 
the ultimate goal of discovering, developing and translating molecular 
imaging technologies that will have eventual impact in the clinic.  This 
structure will provide researchers with access to a concentrated pool of 
expertise in a wide range of disciplines.  The structure of the ICMIC will be 
designed to provide investigators with the means of conducting 
multidisciplinary research in a highly collaborative atmosphere, and 
consistent access to expertise with minimal wasted time and effort.  
Personnel may be scientists from a variety of fields including, but not 
limited to: imaging sciences, chemistry, radiopharmaceutical chemistry, cell 
and molecular biology, pathology, pharmacology, computational sciences, and 
biomedical engineering.  Other specialists in fields such as MRI physics, 
immunology, or neuroscience, for example, may also be involved.  Most 
importantly, ICMIC personnel must demonstrate an eagerness to collaborate 
outside of their own disciplines.  The nature of these interactions will be 
determined by the applicants, and emphasis will be placed on establishing 
creative, productive, and synergistic interactions with eventual clinical 
impact.

2.  The ICMICs will provide funding for a minimum of three Research 
Components.  Research Components will apply multidisciplinary approaches to 
molecular imaging.  Individual research projects will be structured in order 
to maximize appropriate scientific interaction between the projects, and 
coordinated utilization of the Specialized Resources (see below).  Each 
Research Component will be similar in size and scope to a typical R01 or 
subproject of a P01, and will be expected to meet the same standards of 
preliminary data in support of the hypotheses.

3.  The ICMICs will provide Specialized Resource Facilities and Services.  A 
barrier to productive scientific interaction is the lack of available 
facilities for cross-disciplinary experiments.  Demands on equipment, 
resources, and reagents in every scientific area are extremely high, and this 
demand prohibits ready access to investigators interested in expanding their 
studies into new areas of research.  The establishment of Specialized 
Resources dedicated to ICMIC-related research will provide this access.  The 
Specialized Resource(s) will be determined by the requirements of the 
Institution, the defined scientific goals of the Research Components of the 
ICMIC, and budgetary limits.  Prioritization of the research projects 
supported through ICMIC Specialized Resources will be an essential function 
of the ICMIC’s leadership, and the mechanism to be employed for 
prioritization must be delineated by the applicants.  Resource facilities may 
be utilized by active members of the ICMIC and will also be available to 
investigators supported through Developmental Funds (see below).

4.  ICMICs will provide Developmental Funds for feasibility testing of new 
projects.  A high priority of each ICMIC will be the identification and 
support of pilot projects that identify and stimulate interdisciplinary 
projects that will take full advantage of emerging research opportunities.  
The selection of projects will be through a review process established by the 
ICMIC’s leadership.  The portfolio of ongoing projects in any given Program 
is expected to be extremely dynamic.  This fund is not to be used to support 
traditional, ongoing projects that could readily be supported through R01s.  
It is not appropriate for projects that utilize single areas of expertise or 
to support the continuation of previously funded research projects, and 
Developmental Projects may not be supported for more than two years.  
Necessary equipment should be provided through the appropriate Specialized 
Resource. These projects are to be monitored closely by the ICMIC leadership.  
Investigators working on projects supported through the Development Fund must 
understand that they will be expected to compete for independent R01 funding 
when the projects become sufficiently mature. Alternatively, if it becomes 
obvious that the project will not provide the expected results, a plan should 
be in place for terminating a development project.

5.  ICMICs will provide career development opportunities for new and 
established investigators.  Current graduate programs are generally focused 
on single disciplines and may be inadequate to train the needed cadre of 
inter-disciplinary imaging scientists.  The ICMICs will provide support 
for a limited number of pre-and post-doctoral trainees in a program to be 
defined by the applicants.  Career development opportunities through the 
ICMIC will be expected to be highly cross-disciplinary.

MECHANISM OF SUPPORT 

This PAR will use the NIH P50 Specialized Centers Grant Mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  The total project period for a P50 
application submitted in response to this PAR may not exceed five years. The 
total costs requested for a new or competing renewal P50 ICMIC application 
may not exceed a maximum of $2,000,000 per year.  The NCI anticipates 
awarding two new or competing P50 ICMICs each year.

This PAR uses just-in-time concepts.  It also uses the non-modular budgeting 
formats).  Follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#Toc54600040

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 institutions/organizations 
o Foreign institutions are not eligible to apply; foreign components of 
applications from domestic organizations will be accepted with adequate 
justification  

An institution may only have one funded ICMIC.  

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 his or her institution to 
develop an application for support.  Individuals from under-represented 
racial and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS
 
ICMIC investigators will be expected to participate in ICMIC workshops and 
investigator meetings as necessary to share results with other ICMICs, share 
materials, assess progress, identify new research opportunities, and 
establish interactions and research priorities and collaborations.  Travel 
funds for the Principal Investigator and selected ICMIC investigators and 
collaborators may be budgeted for this purpose.

For those projects that involve clinical trials, investigators must include a 
general description of the Data and Safety Monitoring Plan 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) in the 
application.  All clinical trials supported or performed by NIH require some 
form of monitoring. The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the size 
and complexity of the clinical trial. Monitoring exists on a continuum from 
monitoring by the Principal Investigator/project manager or NIH program staff 
to a Data and Safety Monitoring Board (DSMB). These monitoring activities are 
distinct from the requirement for study review and approval by an 
Institutional Review Board (IRB). For details about the Policy of the Data 
and Safety Monitoring of Clinical Trials see, 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.

All investigator-initiated applications with direct costs greater than 
$500,000 in any single year will be expected to address data sharing 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html) in 
their application.  

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PAR 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:

Anne E. Menkens, Ph.D.
Cancer Imaging Program
National Cancer Institute
6130 Executive Blvd., EPN Room 6068
Bethesda, MD  20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-9531
FAX:  (301) 480-3507
Email:  am187k@nih.gov

o Direct your questions about peer review issues to: 

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncirefof@dea.nci.nih.gov

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

Kathryn Dunn
Grants Management Specialist
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., EPS Room 243
Bethesda, MD 20892
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 846-6829
FAX:  (301) 846-5720
Email:  dunnkath@mail.nih.gov

LETTER OF INTENT
 
Prospective applicants are encouraged 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 PAR

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 NCI 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:

Anne E. Menkens, Ph.D.
Cancer Imaging Program
National Cancer Institute
6130 Executive Blvd., EPN Room 6068
Bethesda, MD  20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-9531
FAX:  (301) 480-3507
Email:  am187k@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form.  The PHS 
398 document 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.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS:

1)  Budget(s):

The budget(s) should be presented in logical, discrete units for each section 
of the application using the standard PHS-398 form pages 4-5.  The budgets to 
be submitted should include:

a)  A detailed composite budget for the entire ICMIC;
b)  A separate budget for Administrative and Organizational activities;
c)  A separate budget for each individual Research Component;
d)  A separate budget for each Specialized Resource;
e)  A single separate budget section for the Developmental Component; and
f)  A single separate budget for the Career Development Component.  

Additional pages for budget justification are to be used when necessary.

2)  Research Plan

The following format is suggested for completing the “Research Plan” section 
(see pages 19 through 23 of the PHS 398 application brochure.)  The 
application should be as concise as possible to ensure a thorough review.

a)  ICMIC Description (not to exceed 10 pages)

This section should be used to present the overall vision for the ICMIC.  
This summary should contain the long and short-term scientific objectives, 
specifically addressing how the molecular imaging research supported through 
the ICMIC will impact clinical cancer care.  Summarize the organizational 
structure for the ICMIC, concisely defining Research Components, Specialized 
Resources, the Developmental Fund, and the Career Development Component, and 
their relationships to each other. In addition, relationships between the 
ICMIC and other research, academic, and administrative units of the 
institution (such as centers, institutes, departments) and the central 
administration should be described in this section.  The ICMIC description 
should serve as an overview of the ICMIC, with a more detailed description of 
each component to be presented in a later section.

b)  Organization and Administration (not to exceed 20 pages, including any 
organizational charts).  A separate budget should be prepared and included 
for centralized administrative and organizational activities.  The 
Organizational and Administrative Component should describe all of the 
infrastructure and decision-making needs of the ICMIC.  Appropriate for 
inclusion in this component would be (not necessarily in the following 
order):
o  description of the role(s) and responsibilities of lead investigators, 
internal and external advisory committees as well as participating 
investigators;
o  description of decision-making and oversight responsibilities for each 
Research Component;
o  description of decision-making, oversight responsibilities and anticipated 
utilization for each Specialized Resource.  If existing resources are to be 
utilized by the ICMIC, state explicitly how they differ from new Specialized 
Resources to be established as a part of the ICMIC, and what arrangements 
have been made to ensure access by ICMIC Investigators to those existing 
resources;
o  description of decision-making and oversight responsibilities for the 
Developmental Fund, including the process for selecting, monitoring and 
terminating the Developmental Projects;
o  description of decision-making and oversight responsibilities for the 
Career Development Component, including the process for selecting, monitoring 
and terminating trainees;
o  description of ICMIC-sponsored activities designed to foster 
multidisciplinary interactions, such as regularly scheduled forums for the 
presentation and discussion of multidisciplinary research topics;
o  detailed description of Institutional commitment to the ICMIC; and
o  description(s) of commitment(s) to interact with other ICMICs, including 
Inter-ICMIC meetings.

c)  Research Components (not to exceed 25 pages each)

Research Components will define the scientific projects supporting the long-
term goals of the ICMIC, and are to be presented using the format of a 
traditional research project [Research Plan: Include Sections a-d 
(Instructions for PHS 398, Pages 15-17)].  The leader(s) of each Research 
Component will be responsible for ensuring that ongoing research project(s) 
are relevant to the ICMIC goals, and that the investigators and projects 
remain highly integrated with other ongoing ICMIC research.  Research 
Components may rely on the support of the Specialized Resources.  To ensure a 
sufficient level of multidisciplinary interaction, no fewer than three 
Research Components should be included in the application; the maximum number 
will be determined by the identified needs of the investigators and budgetary 
constraints. The total number of pages for each Research Component is not to 
exceed 25.  Describe each Research Component in sufficient detail to enable 
reviewers to judge the scientific merit from the written application.  Do not 
present separate "subprojects." All projects are to have a single theme, 
project leader and budget. 

Following the description of the scientific goals, each Research Component 
should summarize exactly how the project integrates with the goals of the 
ICMIC, how it will directly support or impact clinical cancer care, how it 
will communicate and complement the other Research Components, and how it 
will utilize the Specialized Resources.  Describe in this section the 
relevance of the project to the primary theme of the ICMIC and the 
collaborations with investigators within the ICMIC.  Explicitly state which 
Specialized Resources will be used by this Research Component, and, if 
possible, quantitate the anticipated usage of Specialized Resources in 
tabular format.  This summary should not exceed 1-2 pages, which are included 
in the 25 page limit for each Research Component section.

d)  Specialized Resources (not to exceed 15 pages each)

Specialized Resources may include laboratory and clinical facilities, 
equipment, and services. For each Specialized Resource, describe in detail 
the resource(s) that it will provide to the ICMIC.  In addition, describe its 
role in the overall functioning of the ICMIC, including how each resource 
will enhance multidisciplinary research, and a description of the projects 
that will be supported by the Specialized Resource.  
1. Using a Form PHS 398 Continuation Page, denote "Specialized Resource" and 
the Specialized Resource director's name. If there is to be more than one 
core component, prepare a separate section for each core (i.e., Specialized 
Resource A, Specialized Resource B, etc.). 
2. For each Specialized Resource, describe the role of the Specialized 
Resource as a core to the ICMIC as a whole. Clearly present the facilities, 
resources, services, and professional skills that the core component 
provides. 
3. To aid in the review, it is suggested that a table to show the estimated 
or actual proportional use of this Specialized Resource by each project, be 
included in the application.  Justify this core component by discussing ways 
in which these centralized services improve quality control, produce an 
economy of effort, and/or save overall costs compared to their inclusion as 
part of each project in the P50 ICMIC. 

e)  Developmental Fund (not to exceed 20 pages)

This section should include a description of the Developmental Project(s) 
that will be initiated during the first year of ICMIC funding, including a 
summary of which Specialized Resources will support the projects, and to what 
level that support will occur. The description of decision-making and 
oversight responsibilities, including the process for selecting, monitoring 
and terminating the Developmental Projects should be included in the 
"Organization and Administration" Section of the application.  This section 
should include only the scientific portion of the Developmental Projects.  
The Developmental Projects should provide an avenue for introducing and 
integrating new investigators and innovative technologies and/or 
methodologies into the ICMIC infrastructure (in specific) and molecular 
imaging (in general).  It should not be viewed as a supplemental source of 
funding for investigators that are already integregally invested in the 
success of the ICMIC.  Since the Developmental Projects will be flexible, 
only the first year of projects should be included in the application.  
However, applicants should include in their budgets appropriate funds to also 
support Developmental Projects in Years 2-5 of the award.  The Developmental 
Fund projects must be multidisciplinary, and each is to be presented using 
the format of a traditional research project [Research Plan: Include Sections 
a-d (Instructions for PHS 398, Pages 15-17)].  The number of Developmental 
Projects to be initiated will be determined by the ICMIC applicants.

f)  Career Development Component (not to exceed 15 pages)

Career Development opportunities sponsored by ICMICs will provide a limited 
number of trainees with access to a highly cross-disciplinary experience.  
The extent of the Career Development Component is to be defined by the 
applicant, based on the needs and capabilities of the ICMIC participants.  
Applicants for career development support may be new investigators or 
established investigators who wish to change research directions.  Candidates 
should be scientists who have demonstrated outstanding research potential but 
who need additional time in a productive scientific environment to establish 
an independent, multidisciplinary research program.  Recruitment must include 
qualified women and minorities.  To this end, each applicant should propose a 
clear policy and plan for recruitment of career development candidates.  The 
ICMIC application should propose the number of slots available, the criteria 
for eligibility and for selection of candidates, and describe the selection 
process.  Also, the application should indicate prospective mentors who are 
already in place at the proposed ICMIC, briefly describe their research 
programs, and describe complementary activities that contribute to the 
environment for career development (e.g., existing training grants, other 
career development mechanisms and relevant programs).

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted by the receipt date(s) listed on the first page 
of this program announcement. 

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 or courier service)

At the time of submission, two additional copies of the application and all 
copies of the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

Appendices should be comprised of single-sided, unbound materials, with 
separators between documents.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e. FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)
This policy is similar to and consistent with the 
policy for applications addressed to Centers for Scientific Review as 
published in the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be received on or before the 
receipt date(s) listed on the first page of this program announcement.  The 
CSR will not accept any application in response to this PAR 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 a substantial revision of an unfunded version 
of an application already reviewed, but such application must include an 
Introduction addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within eight weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NCI.  Incomplete and/or non-responsive applications 
will not be reviewed.

Applications that are complete and responsive to the PAR will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the Division of Extramural Activities of the NCI in accordance 
with the review criteria stated below.  As part of the initial merit review, 
all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Cancer Advisory 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 evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of these criteria in assigning the 
application’s overall score, weighting them as appropriate for each 
application.  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The 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, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.

The overall ICMIC applications will be reviewed using the criteria listed 
below.  For competing renewals, evidence of productivity and productive 
collaborations, such as joint publications, will also be considered.

SIGNIFICANCE:  Does the ICMIC address an important cancer-related imaging 
research problem?  Will the overall research have an impact on clinical 
cancer care?  Are the scientific objective(s) of the Research Components, 
Specialized Resources, Developmental Projects and Career Development Plans 
appropriate and adequate to achieve the long-term goals of the ICMIC?

APPROACH: Is the conceptual framework and the experimental design, methods 
and analyses proposed for each of the ICMIC components sound and feasible?  
Do the individual Research Components interact appropriately with the other 
Research Components and Specialized Resources?

INNOVATION: Are the experimental designs of the proposed research focused on 
cellular and molecular imaging of cancer, and are they original, novel, and 
innovative?

INVESTIGATOR (S): Are the ICMIC Director and leadership appropriately trained 
and well suited to the organizational and scientific responsibilities of the 
ICMIC?  Is there evidence that ICMIC participants are committed to 
productive, multidisciplinary interactions?  

ENVIRONMENT:  Is there evidence of significant commitment of the institution 
to fulfilling the objectives of the ICMIC?  Does the scientific environment 
in which the work will be done contribute to the probability of success?  Do 
the proposed experiments take advantage of unique features in the scientific 
environment?

In addition, each ICMIC component will be reviewed using the following 
criteria:

1)  Organization and Administration:

Is the organizational, scientific, and operational framework reasonable, 
well-integrated, and appropriate to the aims of the ICMIC?  Does the ICMIC 
employ novel approaches or methods for facilitating scientific interaction?  
Are the ICMIC Director and leadership appropriately trained and well suited 
to the organizational and scientific responsibilities associated with this 
project?  Is there sufficient oversight and monitoring of Research 
Components, Specialized Resources, Developmental Funds and Career Development 
Programs?  Is there evidence of significant commitment of the institution to 
fulfilling the objectives of the ICMIC?  If collaborative arrangements are 
proposed, is there a convincing demonstration that these interactions will be 
consistent enough to meet the needs of the ICMIC?

2)  Research Components:

The five criteria to be used to evaluate individual Research Components in 
ICMIC applications are listed below.

a)  SIGNIFICANCE:  Does the Research Component address an important research 
problem related to cancer imaging? Will the research have a direct or 
indirect impact on clinical cancer care?  Does the scientific merit and 
experimental design of the Research Project(s) adequately address issues of 
substantive importance?

b)  APPROACH:  Are the conceptual research framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the aims 
of the project?  Does the applicant acknowledge potential problem areas and 
consider alternative translational approaches? Is there clear evidence of 
significant multidisciplinary basic and clinical interactions in the 
conception, design, and proposed implementation of the project?

c)  INNOVATION:  Does the Research Project(s) develop new methodologies or 
technologies? Is the experimental design of sufficient originality, novelty, 
and innovativeness to make it highly relevant to the overall goals and 
objectives of the ICMIC?

d)  INVESTIGATORS:  Are the lead investigator and the co- investigators 
appropriately qualified with demonstrated competence to conduct the proposed 
research?  Is the proposed work appropriate to the experience level of the 
principal investigator and project researchers?  Are the proposed time 
commitments for all key laboratory and clinical researchers reasonable and 
adequately associated with the project?

e)  ENVIRONMENT:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features in the scientific environment or reach out 
to useful collaborative arrangements? Is there evidence of adequate 
institutional support?

3)  Specialized Resources:

Is each Specialized Resource essential for the conduct of ICMIC?  Is the 
Specialized Resource utilized by more than one Research Component?  Is the 
access to, and distribution of, Specialized Resources focused on meeting the 
goals of the ICMIC?  Are the proposed managers of Specialized Resources 
adequately qualified to conduct high quality, reliable resource operations?  
Are the requested budgets appropriate to conduct each resource operation?

4)  Developmental Projects:

The Developmental Projects will be reviewed as a “cluster,” reflecting the 
cumulative scientific strength of the projects and the process, rather than 
assigning each project an independent merit rating.   Do the Developmental 
Projects demonstrate innovate approaches that integrate multiple scientific 
disciplines?  Do these projects reflect a careful selection process focused 
on scientific quality and innovation?  Do the Developmental Projects 
establish new, multidisciplinary collaborations focused on cellular and 
molecular imaging of cancer, and are the projects original and innovative?

5)  Career Development Program:

Is the Career Development Program well justified, and does it describe a 
program that will successfully train investigators capable of establishing 
independent multidisciplinary imaging research programs?  Are the proposed 
mentors in the Career Development Program experienced in the types of 
training proposed?  Is the process for selecting candidates for training 
adequate, and does it seek out and include qualified minorities and women?

The initial review group will also examine the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders 
and minorities and their subgroups as appropriate for the scientific goals of 
the research and plans for the recruitment and retention of subjects; the 
adequacy of plans for including children as appropriate for the scientific 
goals of the research, or justification for exclusion; the provisions for the 
protection of human and animal subjects; and the safety of the research 
environment.

A single numerical priority score will be assigned to the program as a whole.  
Although primary emphasis will be placed on scientific merit and 
innovativeness, significant consideration will be given to multidisciplinary 
interactions, potential for impacting on the field, and institutional 
commitment.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below.)
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. 
 
BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PAR will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review;
o Availability of funds; and 
o Relevance to program priorities.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  June 22, 2004; June 21, 2005 
Application Receipt Date:  July 22, 2004; July 21, 2005
Peer Review Date:  October 2004; October 2005; 
Council Review:  February 2005; February 2006; 
Earliest Anticipated Start Date:  April 2005; April 2006; 

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.  See 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  (See NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials, see 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  For 
additional information, see NIH Guide Notice on “Further Guidance on a Data 
and Safety Monitoring for Phase I and II Trials” at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available at 
http://www.cancer.gov/clinical_trials/.

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or 
more in direct costs in any single year are expected to include a plan for 
data sharing (http://grants.nih.gov/grants/policy/data_sharing) or state why 
this is not possible.  Investigators should seek guidance from their 
institutions, on issues related to institutional policies, local IRB rules, 
as well as local, state and Federal laws and regulations, including the 
Privacy Rule. Reviewers will consider the data sharing plan but will not 
factor the plan into the determination of the scientific merit or the 
priority score.

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 "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.  A 
continuing education program in the protection of human participants in 
research is available online at http://cme.nci.nih.gov/.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project 
description and elsewhere in the application as appropriate, 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 PAR 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information,” 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 .All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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