DEVELOPMENT OF NOVEL IMAGING TECHNOLOGIES (PHASED INNOVATION AWARD)

Release Date:  April 27, 2000

PA NUMBER: PAR-00-089

National Cancer Institute
National Center for Research Resources

Letter of Intent Receipt Dates: June 14, 2000 and February 9, 2001
Application Receipt Dates: July 19, 2000 and March 16, 2001

PURPOSE

The National Cancer Institute (NCI) invites applications on the development 
of novel image acquisition or enhancement methods, incorporating limited 
pilot or feasibility evaluations using either pre-clinical models or clinical 
studies.  This initiative is intended to facilitate the development of novel 
imaging technologies for early detection, screening, diagnosis and image 
guided treatment of cancer and other diseases.  The intent is to stimulate: 
(a) the development of highly innovative image acquisition and enhancement 
methods, including high risk/high gain research on technologies that exploit 
our knowledge of the molecular basis of cancer or other disease, and (b) the 
integration of these emerging technologies with traditional imaging methods 
for more effective health care delivery. 

The motivation for this Program Announcement (PA) is that current 
technologies for the molecular analysis of disease are largely restricted to 
in-vitro methods and need to be extended to the in-vivo situation. 
Furthermore, the use of molecular probes or tracers for imaging molecular 
events in pre-clinical or human investigations is considered essential for 
detection of molecular changes in-vivo. The development of innovative high-
resolution imaging methods at the cellular or molecular scales is needed, 
with a particular emphasis on identification and characterization of either 
the early formation of disease processes or early molecular changes during 
intervention or therapy.  

This solicitation (Development of Novel Imaging Technologies) will utilize 
the Phased Innovation Award Mechanism that is designed to encourage 
technology development.  Specific features of this mechanism include:

o  Single submission and evaluation of both the R21 and R33 phases as one 
application.  An R33 application alone may be submitted.
o  Expedited transition of feasibility phase (R21) to development phase 
(R33), based on completion of negotiated Milestones.
o  Flexible staging of feasibility (R21) and development (R33) phases.   
Industry applications or industry partnerships with other groups are 
encouraged.

Small businesses are encouraged to respond to a parallel PA PAR-00-090 (see 
http://grants.nih.gov/grants/guide/pa-files/PAR-00-090.html) of identical 
scientific scope that uses the SBIR and STTR mechanisms, but with similar 
expedited review and transition, as well as cost and duration limits, as the 
Phased Innovation Awards. 

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 PA, Development of 
Novel Imaging Technologies (Phased Innovation Award), is related to the 
priority area of cancer and several other priority areas. Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, companies, units of State and local governments, and 
eligible agencies of the Federal government.  Racial/ethnic minority 
individuals, women, and persons with disabilities are encouraged to apply as 
principal investigators.

MECHANISM OF SUPPORT

The following are points to note about the mechanism of support and its 
implementation:
o Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  Awards will be administered 
under NIH grants policy as stated in the NIH Grants Policy Statement, NIH 
Publication Number 99-8, October 1998.
o  Support for this program will be through the National Institutes of Health 
(NIH) Exploratory/Developmental Research Grant (R21) and the 
Exploratory/Developmental Research Grant Phase 2 (R33).  The R33 is a 
relatively new NIH grant mechanism that provides a second phase to support 
innovative exploratory and developmental research initiated under the R21 
mechanism.  Transition of the R21 to the R33 phase will be expedited and is 
dependent on completion of negotiated Milestones.
o  Under this PA, applicants can submit either a combined R21/R33 application 
(Phased Innovation Award application) or an R33 application alone, if 
feasibility can be documented, as described in the APPLICATION PROCEDURES 
section of this PA.
o  Applications for R21 support alone will not be accepted, but may be 
eligible to apply under PA-98-008 (see 
http://grants.nih.gov/grants/guide/pa-files/PA-98-008.html) or PAR-98-047 
(http://grants.nih.gov/grants/guide/pa-files/PAR-98-047.html)
o  The total project periods for an application submitted in response to this 
PA may not exceed the following durations: R21, 2 years; R33, 3 years; 
combined R21/R33 application, 4 years.  In the combined application the R21 
phase cannot extend beyond 2 years.
o  For combined R21/R33 applications, the R21 phase may not exceed $100,000 
direct costs per year.  R21 budgets can exceed this cap to accommodate 
Facilities and Administrative costs to subcontracts to the project.  Although 
the R33 application has no official budgetary limit, applications requesting 
in excess of $500,000 direct costs in any single year of the grant period 
require prior approval by NCI or NCRR program staff before submission.
o  It is strongly recommended that applicants contact NCI or NCRR staff at an 
early stage of application development to convey critical information, such 
as potentially large budget requests or to discuss programmatic 
responsiveness of the proposed project.  Early contact with NCI or NCRR staff 
is particularly helpful for this PA because it uses a relatively new grant 
mechanism (R33). Refer to the INQUIRIES sections of this PA for NCI and NCRR 
staff contacts.
o  The combined R21/R33 application offers two advantages over the regular 
application process:
1.  Single submission and evaluation of both the R21 and the R33 as one 
application.

2.  Minimal or no funding gap between R21 and R33.  The award of R33 funds 
will be based on program priorities, on the availability of funds and on 
successful completion of negotiated scientific Milestones as determined by 
NCI and NCRR staff in the context of peer review recommendations.

To be eligible for the Phased Innovation Award, the R21 phase must include 
well-defined, quantifiable Milestones that will be used to judge the success 
of the proposed research, as well as a credible plan for the development of 
technology in the R33 phase. The Phased Innovation Award must have a separate 
section labeled Milestones at the end of the Research Plan of the R21 
application. This section must include well-defined, quantifiable Milestones 
for completion of the R21 part of the application, a discussion of the 
suitability of the proposed Milestones for assessing the success in the R21 
phase, and a discussion of the implications of successful completion of these 
Milestones for the proposed R33 study.

Through a separate program announcement PAR-00-090 
(http://grants.nih.gov/grants/guide/pa-files/PAR-00-090.html), the NCI and 
NCRR are inviting applications for SBIR and STTR support, focusing on the 
same research areas as described in the RESEARCH OBJECTIVES section of this 
solicitation. For SBIR/STTR solicitation, the expedited NCI review and cost 
allowance policies and procedures will be identical to this PA.  Qualified 
applicants are strongly encouraged to consider responding to the SBIR/STTR 
program announcement.  SBIR and STTR application information is available at 
the following website: http://grants.nih.gov/grants/funding/sbir.htm

Potential applicants who believe that they may be eligible for the SBIR/STTR 
award should contact the  NCI staff listed under INQUIRIES to discuss this 
issue.  In addition, potential applicants are encouraged to access the PHS 
SBIR and STTR Omnibus Solicitation for information on eligibility 
requirements at the following website: 
http://grants.nih.gov/grants/funding/sbirsttr1/index.htm   

BACKGROUND

Significant advances in medical imaging technologies have been made over the 
last 25 years in such areas as magnetic resonance imaging (MRI), computed 
tomography (CT), nuclear medicine and ultrasound. However, these advances 
largely focused on structural or anatomic imaging at the organ or tissue 
level. There is clearly a need and opportunity now to stimulate the 
development and integration of novel imaging technologies that exploit our 
current knowledge of the genetic and molecular bases of cancer.  Those 
molecular biological discoveries have great implications for prevention, 
detection and targeted therapy. Imaging technologies that can provide in vivo 
the same kind of cellular and molecular information that is currently 
available only from in vitro techniques would be very useful. This is 
commonly referred to as in vivo molecular imaging. 

Participants at several NCI-supported forums over the last few years [Imaging 
Sciences Working Group (ISWG) July 1997; Lung Imaging Workshop: Technology 
Transfer, Jan 1997; Computer Aided Diagnosis and 3D Image Analysis, Oct 1998; 
Quantitative In-Vivo Functional Imaging in Oncology, Jan 1999; Focus Group on 
Magnetic Resonance Spectroscopy (MRS) in Clinical Oncology, April 1999; and 
NIH BECON Symposium, June 1999] stressed the need for NCI to support 
bioengineering and technology development by academia and industry.  The 
needs are to (a) promote the development of very novel (high risk, high gain) 
technologies, including continued support for their maturation and full 
exploitation, (b) promote system integration of technologies for targeted 
applications, and (c) improve technology transfer by promoting partnerships 
between academia and industry.  

Development of novel imaging technologies will require a multidisciplinary 
team approach with broad expertise in a variety of research areas.  Such 
varied expertise, potentially including but not limited to, expertise in 
imaging physics, molecular and cellular biology, informatics and 
biostatistics exists in ongoing cancer centers and clinical trials 
cooperative groups. The coordination and collaboration of investigators from 
these various disciplines to demonstrate the utility and applicability of new 
imaging methods is considered to be a high priority.

RESEARCH OBJECTIVES

The intent of this PA is to stimulate: (a) the development of highly 
innovative image acquisition and enhancement methods, including high risk/ 
high gain projects that exploit our expanding knowledge of the molecular 
basis of cancer and other diseases, and (b) the integration of these emerging 
technologies with traditional imaging modalities for more effective solutions 
for cancer and other diseases. In particular, the development of innovative 
high-resolution imaging methods at the cellular or molecular scales is 
needed, with emphasis on identification and characterization of either the 
early formation of disease or early molecular changes during intervention or 
therapy. For many technologies that have potential for molecular imaging, the 
use of probes or tracers is considered essential for detection of molecular 
changes in-vivo. 

The following clinical applications are appropriate for inclusion in proposed 
projects:

*Imaging to detect early changes.
The development of innovative high-resolution imaging methods at the cellular 
or molecular scales is encouraged, with a particular intent to identify and 
characterize pre-malignant abnormalities or other early changes. Novel 
solutions for in-vivo microscopic imaging sensors, or microscopic implanted 
devices with high spatial, contrast and temporal resolution are encouraged. 
Similarly the use of contrast enhancement methods and imaging probes is also 
encouraged. The imaging methodologies proposed should emphasize analysis of 
molecular events on the path to disease. 

*Large scale screening applications for cancer and other diseases. 
Development and optimization of efficient low-cost imaging systems for rapid 
and automated large-scale screening with the intent of achieving 
significantly higher sensitivity and specificity for cancer and other disease 
detection are encouraged.  Applications could address significant innovative 
improvements to current imaging methods or new emerging imaging sensors.  
Research topics of interest include, but are not limited to, technologies for 
molecular imaging, means to significantly reduce imaging time or motion 
effects, use of novel contrast agents or imaging probes, and use of 
technologies that do not involve ionization radiation.  System integration 
could include a variety of image processing techniques including temporal 
analysis of serial studies, close to real-time image processing, novel image 
display methods, and related imaging informatics and information reduction 
methods for more cost-effective solutions for screening. 

*Imaging for diagnosis, staging, or monitoring the effects of therapy. 
This initiative encourages the development of novel imaging methods such as 
functional or molecular imaging or spectroscopy methods that would 
significantly improve the specificity of diagnosis of cancer and other 
diseases, allow deterministic methods or patient-specific staging, or measure 
early effects of therapy.  Examples of system integration would include image 
fusion or registration from the different modalities employed, development of 
software methods that would estimate the probability of malignancy or other 
specific disease identification, quantitative information for monitoring the 
effects of therapy, and close to real-time image analysis.

*Image guided biopsy (IGB) and therapy (IGT).  
Novel approaches using imaging technologies are needed to significantly 
improve specificity, to identify lesion extent and microscopic involvement, 
and to minimize the tissue damage accompanying biopsy and therapy. Of 
particular interest are innovative approaches to IGB or IGT that include 
novel imaging sensors that provide information at the cellular or molecular 
level. Examples of system integration that are of interest include, but are 
not limited to, navigational systems, registration methods for several 
imaging modalities, real-time feedback mechanisms for controlling therapy or 
the use of methods that are adaptive or allow patient-specific optimization 
of treatment.

This list is not meant to be all-inclusive and prospective applicants are 
encouraged to discuss program relevance issues with program staff cited under 
INQUIRIES.

Partnerships of appropriate medical institutions with medical device 
manufacturers to facilitate the integration of system components are 
encouraged.  

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research", which have been published in the Federal Register of March 28, 
1994(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 
23, Number 11, March 18, 1994, available on the web at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 clear and compelling 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 was published in the "NIH Guide for 
Grants and Contracts", March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by the date listed at the 
beginning of this PA, a letter of intent that includes  a descriptive title 
of the proposed research, the name, address, telephone number, and e-mail 
address of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of the PA in 
response to which the application may be submitted.

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 and NCRR staff to estimate the potential review workload 
and plan the review.  The letter of intent is to be sent to Dr. Barbara Croft 
at the address listed under INQUIRIES. 

APPLICATION PROCEDURES

SPECIFIC INSTRUCTIONS FOR PREPARING THE COMBINED R21/R33 PHASED INNOVATION 
AWARD APPLICATION:

Applications for R21/R33 grants are to be submitted on the grant application 
form PHS 398 (rev. 4/98) and prepared according to the instructions provided 
unless specified otherwise within this section.  Application kits are 
available at most institutional offices of sponsored research and may be 
obtained from the Division of Extramural Outreach and Information Resources, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-
0714, email: grantsinfo@nih.gov.  See also the website for PHS 398: 
http://grants.nih.gov/grants/funding/phs398/phs398.html

The R21/R33 application must include the specific aims for each phase and the 
Milestones that would justify transition to the R33 phase.  See below, Item 
d., "Research Design and Methods" for directions for including Milestones in 
the application.  For applications that are funded through this solicitation, 
completion of the R21 Milestones will elicit an NCI expedited review that 
will determine whether or not the R33 should be awarded. The release of R33 
funds will be based on successful completion of negotiated scientific 
Milestones, program priorities, and on the availability of funds. The 
expedited review may result in additional negotiations of award.
The R21/R33 Phased Innovation Award application must be submitted as a single 
application, with one face page.  Although it is submitted as a single 
application, it should be clearly organized into two phases.  To accomplish a 
clear distinction between the two phases, applicants are directed to complete 
Sections a-d of the Research Plan twice: one write-up of sections a-d and 
Milestones for the R21 phase and sections a-d again for the R33 phase.  The 
Form 398 Table of Contents should be modified to show sections a-d for each 
phase as well as the Milestones.  There is a page limit of 25 pages for the 
composite a-d text (i.e., sections a-d and Milestones for the R21 and 
sections a-d for the R33 phase all must be contained within the 25-page 
limit.)
In preparing the R21/R33 application, investigators should consider the fact 
that applications will be assigned a single priority score.  In addition, as 
discussed in the REVIEW CONSIDERATIONS section, the initial review panel has 
the option of recommending only the R21 phase for support.  However, a Phased 
Innovation Award Application with an R33 Phase that is so deficient in merit 
that it is not recommended for support will reflect upon the judgment of the 
applicant.  For these reasons, the clarity and completeness of the R21/R33 
application with regard to specific goals and feasibility Milestones for each 
phase are critical.  The presentation of Milestones that are not sufficiently 
scientifically rigorous to be valid for assessing progress in the R21 phase 
will reflect upon the scientific judgment of the applicant.

1.  Face Page of the application:
Item 2.  Check the box marked "YES" and type the number and title of this PA. 
Also indicate if the application is a R21/33 or R33.

Item 7a, DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT:
This PA does NOT use the "Modular Grant" and "Just-in-time" concepts. For the 
R21 phase of the combined R21/R33 application, direct costs are limited to a 
maximum of $100,000 per year for a maximum of two years and the award may not 
be used to supplement an ongoing project.  The requested budgets can exceed 
this cap to accommodate for Facilities and Administrative costs to 
subcontracts to the project.  Insert the first year of R21 support in item 
7a. Modular Grant Application instructions in PHS 398 do NOT apply to this 
PA.

Item 8a, DIRECT COSTS REQUESTED FOR PROPOSED PERIOD OF SUPPORT:
For the R21 phase, direct costs requested for the proposed period may not 
exceed $100,000 per year for two years of support.  The statement in item 7a 
above pertaining to subcontract costs also applies here.  Insert sum of all 
years of requested support in item 8a.

2.  Page 2 - Description:
As part of the description, identify concisely the technology or methodology 
to be developed, its innovative nature, its relationship to presently 
available capabilities, and its expected impact on imaging technology. 

3.  Budget: The application should provide a detailed budget for Initial 
Budget Period (form page 4), for each of the initial years of the R21 and R33 
phases as well as a budget for the entire proposed period of support (form 
page 5). Form pages should indicate which years are R21 and R33. All budgets 
should include a written justification.
An annual meeting of all investigators funded through this program will be 
held to share progress and research insights that may further progress in the 
program.  Applicants should request travel funds in their budgets for the 
principal investigator and one additional senior investigator to attend this 
annual meeting. 

4.  Research Plan:
Item a., Specific Aims.
The applicants must present specific aims that the applicant considers 
scientifically appropriate for the relevant phases of the project.
The instructions in the PHS 398 booklet for this section of research grant 
applications suggest that the applicant state the hypotheses to be tested.  
Since the goal of this PA is the development of innovative imaging 
technologies, hypothesis testing per se may not be the driving force in 
developing such a proposal and, therefore, may not be applicable. For the R21 
portion of the grant application, preliminary data are not required, although 
they should be included when available.  For both the R21 and R33 phase, 
research that develops new technologies is likely to require the application 
of principles from fields such as engineering, biomedical engineering, 
materials science, physics, mathematics, and computer science. Clear 
statements of these underlying principles within this section are essential. 

Item b., Background and Significance
Elaborate on the innovative nature of the proposed research. Clarify how the 
technology development proposed in this project is a significant improvement 
over existing approaches, based on a literature review of this topic.  
Explain the potential of the proposed technology and technology integration 
for having a broad impact on research, diagnosis or treatment of cancer 
and/or other diseases. Clearly identify how the project, if successful, would 
result in new capabilities for diagnosis and treatment, the immediacy of the 
opportunity, and how these proposed technologies would differ from existing 
technologies.

Item c., Preliminary Studies/Progress Report
While preliminary data are not required for submission of the R21 phase, this 
section should provide current thinking or evidence in the field to 
substantiate feasibility of the R21 phase. The R33 need not repeat 
information already provided in the R21.  In the event that an applicant 
feels that technology is too proprietary to disclose, applicants at a minimum 
should provide a demonstration (results) of the capabilities of the proposed 
technology.

Item d., Research Design and Methods
Follow the instructions in the PHS 398 booklet.  In addition, for the R21 
phase only, the following information must be included as a final section of 
Item d:
Applications must include a specific section labeled Milestones following the 
Research Design and Methods of the R21 phase.  The Milestones are a measure 
of whether the specific aims have been accomplished and whether proof of 
principle has been established for the R21 phase.  Milestones should be well 
described, quantifiable, and scientifically justified and not be simply a 
restatement of the specific aims. A discussion of the Milestones relative to 
the success of the R21 phase, as well as the implications of successful 
completion of the Milestones for the R33 phase and the page number of the 
Milestones section should be listed. This separate section should be 
indicated in the Table of Contents.  Applications lacking Milestone 
information as determined by the NCI program staff, will be returned to the 
applicant without review.

SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R33 APPLICATION WHEN SUBMITTED 
WITHOUT THE R21 PHASE.
Applications for R33 grants are to be submitted on the grant application form 
PHS 398 (rev. 4/98) and prepared according to the instructions provided 
unless specified otherwise within items 1-5 below.  Application kits are 
available at most institutional offices of sponsored research and may be 
obtained from the Division of Extramural Outreach and Information Resources, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-
0714, email: grantsinfo@nih.gov.  See also the website for PHS 398: 
http://grants.nih.gov/grants/funding/phs398/phs398.html

1.  Face Page of the application:
Item 2.  Check the box marked "YES" and type the number and title of this PA 
and indicate R33.

2.  Page 2 Description:
As part of the description, identify concisely the technology or methodology 
to be developed, its innovative nature, its relationship to presently 
available capabilities and its expected impact on the diagnosis or treatment 
of cancer and/or other diseases.

3.  Research Plan:
Item a., Specific Aims.
The instructions in the PHS 398 booklet for this section of research grant 
applications suggest that the applicant state the hypotheses to be tested. 
Because the goal of this PA is to develop innovative technologies, hypothesis 
testing per se may not be the driving force in developing such a proposal 
and, therefore, may not be applicable.

Item b., Background and Significance
Elaborate on the innovative nature of the proposed research. Clarify how the 
technology development or any related technology integration for effective 
solutions proposed in this project is a significant improvement over existing 
approaches. Explain the potential of the proposed technology for having a 
broad impact on research, diagnosis or treatment of cancer and other 
diseases. Clearly identify how the project, if successful, would result in 
new capabilities for diagnosis and treatment, the immediacy of the 
opportunity, and how these proposed technologies would differ from existing 
technologies.

Item c., Preliminary Studies/Progress report
This section must document that feasibility (proof of principle) studies have 
been completed, and progress achieved, equivalent to that expected through 
the support of an R21 project.  The application must clearly describe how the 
exploratory/developmental study is ready to scale up to an expanded 
development stage. In the event that an applicant feels that the technology 
is too proprietary to disclose, applicants at a minimum should provide a 
demonstration (results). Ideally, performance capabilities of the proposed 
technology, or quantitative performance characteristics, should be provided 
that may be objectively evaluated and compared to the published literature.

Item d., Research Design and Methods
Follow the instructions in the PHS 398 booklet.

FOR ALL APPLICATIONS

Appendix:  All instructions in the Form 398 application kit apply.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.  (see  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html).

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
(20817 for express service)

At the time of submission, two additional copies of the application must be 
sent to:

Ms. Toby Friedberg
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8062, MSC 8239
Bethesda, MD 20892-8239
Rockville, MD 20852 (for overnight/courier service)
Telephone:    (301) 496-3428
FAX:    (301) 402-0275

Applications must be received by dates given above.  If an application is 
received after that date, it will be returned to the applicant without 
review. The Center for Scientific Review (CSR) will not accept any 
application in response to this PA that is essentially the same as one 
currently pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is essentially the 
same as one already reviewed.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the CSR for completeness and 
by NCI program staff for adherence to the guidelines of this PA.  
Applications not adhering to application instructions described above and 
those applications that are incomplete as determined by CSR or by NCI program 
staff will be returned to the applicant without review. 

Applications that are complete and adhere to the guidelines of this PA will 
be evaluated for scientific and technical merit by an appropriate peer review 
group convened by the NCI in accordance with the review criteria stated 
below.  As part of the initial merit review, all applicants will receive a 
written critique and may undergo a process in which only those applications 
deemed to have the highest scientific merit, generally the top half of the 
applications, will be discussed, assigned a priority score, and receive a 
second level review by the appropriate national advisory board/council.

Review Criteria: 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score, weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a major scientific impact and thus deserve a high priority 
score. 

1.  Significance.  Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?  To what degree does the technology support the needs for 
the targeted disease? 

2.  Approach.  Are the conceptual framework, design, and methods adequately 
developed, well integrated, and appropriate to the aims of the project?  Does 
the applicant acknowledge potential problem areas and consider alternative 
tactics? What is the time frame for developing the proposed technologies and 
suitability of this time frame for meeting the community's needs?  How easy 
will it be to use the proposed technology?  Are the plans for the proposed 
technology, its integration as an effective solution for implementation and 
dissemination adequate? If industry partnerships are proposed, how will they 
facilitate the development and integration of system components? 

3.   Milestones (for R21/R33 applications) and Proof of Principle (for R33 
applications).  For the R21/R33 applications, how appropriate are the 
proposed Milestones against which to evaluate the demonstration of 
feasibility for transition to the R33 development phase?  For the R33 
applications, how well has feasibility or proof of principle been 
demonstrated? 

4.   Innovation.  Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project challenge 
existing paradigms or develop new methodologies or technologies? What is the 
throughput and cost effectiveness of the proposed technology?  What 
additional uses can be projected for the proposed technology?

5.   Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

6.   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 of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional 
support?

Additional Considerations

For the R21/R33 Phased Innovation Award Application, the initial review group 
will evaluate the specific goals for each phase and the feasibility 
Milestones that would justify expansion to the R33 phase. A single priority 
score will be assigned to each scored application.  As with any grant 
application, the initial review group has the option of recommending support 
for a shorter duration than that requested by the applicant, and basing the 
final merit rating on the recommended portion of the application.  For the 
R21/R33 application, this may result in a recommendation that only the R21 
phase be supported, based on concerns related to the applicant specific goals 
and the feasibility Milestones justifying expansion to the R33 phase.  
Deletion of the R33 phase by the review panel or inadequate Milestones will 
affect the merit rating of the application.

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

AWARD CRITERIA

Applications recommended by the appropriate national advisory board/council 
will be considered for award based upon (a) quality of the proposed project 
as determined by peer review; (b) availability of funds; and (c) program 
priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Barbara Y. Croft, Ph.D.
Biomedical Imaging Program
National Cancer Institute
6130 Executive Plaza, Suite 800
Bethesda, MD  20892-2590
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-9531
FAX:  (301) 480-5785
Email:  bc129b@nih.gov

Abraham Levy, Ph.D.
Biomedical Technology
National Center for Research Resources
6705 Rockledge Drive, Room 6150
Bethesda, MD  20892-7965
Telephone:  (301) 435-0755
FAX:  (301) 480-3659
Email: al26y@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Kathleen Shino
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
6120 Executive Boulevard
Bethesda, MD  20892-7150
Telephone:  (301) 496-8635
FAX:  (301) 496-8601
Email: shinok@gab.nci.nih.gov

Ms. Judith Musgrave
OGM/NCRR
One Rockledge Center
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Phone:  (301) 435-0841
FAX: (301) 480-3777
Email address: judithm@ep.ncrr.nih.gov

Direct inquiries regarding review matters to:

Ms. Toby Friedberg
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8062, MSC 8239
Bethesda, MD 20892-8239
Rockville, MD 20852 (for overnight/courier service)
Telephone:    (301) 496-3428
FAX:    (301) 402-0275
Email: tf12W@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.394, Cancer Detection and Diagnosis Research (NCI) and No.93.371, 
Biomedical Technology (NCRR).  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 and Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-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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