DEVELOPMENT OF NOVEL TECHNOLOGIES FOR IN VIVO IMAGING (SBIR/STTR)

Release Date:  May 29, 2001 (see replacement PAR-03-125)

PA NUMBER:  PAR-01-102

National Cancer Institute
National Institute of Environmental Health Sciences

Letter of Intent Receipt Dates:  June 11, 2001, February 11, 2002 and 
                                 June 11, 2002.

Application Receipt Dates: July 16, 2001, March 18, 2002, and July 16, 2002.

This PAR is a reissue of PAR-00-090, which was published in the NIH Guide on 
April 27, 2000.

PURPOSE

The National Cancer Institute (NCI) and the National Institute of 
Environmental Health Sciences (NIEHS) invite applications for the 
development of novel image acquisition or enhancement methods, and 
which may incorporate limited pilot or clinical feasibility evaluations 
using either pre-clinical models or clinical studies.  This initiative 
is intended to facilitate the proof of feasibility and development of 
novel imaging technologies for early detection, screening, diagnosis or 
image guided treatment of cancer (NCI) and environmentally induced 
diseases (NIEHS), and to facilitate clinical evaluation studies of the 
development that are specifically limited to proof of concept.  The 
National Institute of Biomedical Imaging and Bioengineering (NIBIB) may 
accept assignments of grant applications that address development of 
novel imaging technologies that are not organ or disease specific.  
Specific emphasis of this PAR is directed at (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 and environmentally induced diseases, 
and (b) the development of other novel imaging methods and the 
integration of these technologies with emerging molecular imaging 
methods, where appropriate, 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, developments of molecular probes or tracers for 
imaging molecular events in pre-clinical and clinical investigations 
are essential for detection of molecular changes in vivo. Developments 
of innovative, high-resolution imaging methods at the cellular or 
molecular scales are needed, with particular emphasis on identification 
and characterization of processes in the early formation of disease or 
early molecular changes during intervention or therapy. Integrations of 
these emerging molecular imaging methods with advances in traditional 
imaging methods are also required for more effective in vivo 
investigations of environmentally induced disease and cancer.

This PA (Development of Novel Technologies for in vivo Imaging 
(SBIR/STTR)) will utilize the Small Business Innovation Research (SBIR) 
and Small Business Technology Transfer (STTR) mechanisms that are 
designed to encourage technology development by eligible small 
businesses.  This PA must be read in conjunction with the current 
Omnibus Solicitation of the National Institutes of Health, Small 
Business Innovation Research (SBIR) and Small Business Technology 
Transfer (STTR) Grant Applications   
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf).  An SBIR 
and STTR application responding to this PA may be submitted as a Phase 
I, Phase II or “Fast Track” pair of Phase I and Phase II applications. 
The Fast Track applications will benefit from expedited evaluation of 
progress following the Phase I feasibility study for transition to 
Phase II funding for expanded developmental work.  Applications will 
undergo expedited review, and will be subject to cost and duration 
guidelines that are expanded over those stated in the Omnibus 
Solicitation of the National Institutes of Health, Small Business 
Innovation Research (SBIR) and Small Business Technology Transfer 
(STTR) Grant Applications (PHS 2001-2).  All of the instructions in the 
current PHS Omnibus Solicitation for SBIR/STTR Grant Applications 
apply, except for the following:

o  Special receipt dates (see above);

o  Review by an NCI special study section; 

o  Up to 2 years of Phase I feasibility study support, up to 3 years of 
Phase II developmental study support; but a 4 year limit of support for 
both Phase I and II, whether submitted separately or together as a Fast 
Track;

o  Additional review criteria..

There is a parallel NCI program announcement of identical technical and 
scientific scope that utilizes a new Phased Innovation Award mechanism 
(R21/R33) that is intended primarily for applicants other than small 
businesses, originally issued as PAR-00-089 (see 
http://grants.nih.gov/grants/guide/pa-files/PAR-00-089.html), and which 
is being reissued concurrently with this PA as PAR-01-101 (see 
http://grants.nih.gov/grants/guide/pa-files/PAR-01-101.html).  

BACKGROUND

Significant advances in medical imaging technologies have been made 
over the past 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 anatomical 
imaging at the organ or tissue level. Now there is a clear need and 
opportunity to stimulate the development and integration of novel 
imaging technologies that exploit our current knowledge of the genetic 
and molecular bases of environmentally induced disease and cancer.  
Molecular biological discoveries have great implications for 
prevention, detection, and targeted therapy. Imaging technologies that 
can provide similar kinds of cellular and molecular information in vivo 
that are currently available only from techniques in vitro would be 
very useful. This is commonly known as in vivo molecular imaging.

The need for NCI to encourage and support bioengineering and technology 
development by academic and industrial researchers was stressed by 
participants at several NIH- and NCI-supported forums over the past 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].  The needs are to (a) promote the development of novel, high 
risk, high gain technologies, including continued support for their 
maturation and full exploitation, (b) promote system integration of 
technologies for targeted applications, including the development of a 
system prototype and small number of copies, as required, for research 
and clinical feasibility studies, and (c) improve technology transfer 
by promoting partnerships between academia and industry.  The NIEHS has 
reached similar conclusions, which motivated their joining in this PA.

Developments of novel imaging technologies usually will require 
multidisciplinary approaches to provide teams with broad expertise in a 
variety of research areas.  Such varied expertise might include imaging 
physics, engineering, chemistry, molecular and cellular biology, 
informatics and biostatistics. The coordination and collaboration of 
investigators with the necessary variety of disciplines to demonstrate 
the utility and applicability of new imaging methods is encouraged.

RESEARCH OBJECTIVES

This initiative is primarily intended to facilitate the development of 
novel imaging technologies for early detection, screening, diagnosis or 
image guided treatment of cancer and environmentally induced disease, 
and to facilitate clinical evaluation studies of the development that 
are specifically limited to proof of concept. Specific emphasis of this 
PAR is directed at (a) developments 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 and environmentally induced disease, and (b) 
developments of other novel imaging methods and their integration with 
emerging molecular imaging methods, where appropriate, for more 
effective health care delivery.   In particular, developments of 
innovative, high-resolution imaging methods at the cellular or 
molecular scales are needed for both pre-clinical models and clinical 
studies, with emphasis on identification and characterization of either 
the early formation of disease or early molecular changes during 
intervention or therapy. Methods that establish “ground truth” are 
required at appropriate levels of resolution to validate these emerging 
imaging methods.  They may include the imaging of excised tissue using 
protocols similar to those used for imaging in vivo.  Developments of 
probes or tracers are considered essential for detection of molecular 
changes in vivo to take better advantage of many technologies with 
potential for molecular imaging. 

The following objectives would make appropriate topics for proposed 
projects. This list is not meant to be all-inclusive. 

o   Imaging to detect early changes.  Developments of innovative high-
resolution imaging methods at the cellular or molecular scales are 
encouraged, with a particular intent to identify and characterize pre-
malignant abnormalities or early changes preceding the development of 
other diseases. Novel solutions for in vivo microscopic imaging 
systems, or microscopic implanted devices with high spatial, contrast 
and temporal resolution are encouraged. Similarly, developments of 
contrast enhancement methods and imaging probes are also encouraged. 
Proposed imaging methodologies that emphasize analysis of molecular 
events on the path to disease are encouraged. 

o   Large scale screening applications for cancer and environmentally 
induced disease. 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 disease detection are encouraged.  Applications could address 
significant innovative improvements to current imaging methods or new 
emerging imaging systems.  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 ionizing 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. 

o   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 environmentally induced disease, 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.

o   Image guided biopsy (IGB), therapy (IGT), and interventional 
procedures. 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, IGT or interventional methods that include novel imaging systems 
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 and computer-assisted surgery

MECHANISMS 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.  

o  Awards will be administered under NIH grants policy as stated in the 
NIH Grants Policy Statement, March 2001, available at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/index.htm. Hard copies 
are not available.   Support for this program will be through the 
National Institutes of Health (NIH) SBIR/STTR grant program described 
in the “Omnibus Solicitation of the National Institutes of Health for 
Small Business Innovation Research (SBIR) and Small Business Technology 
Transfer (STTR) Grant Applications” 
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf)

o    The total project period for an application submitted in response 
to this PA may not exceed the following durations: Phase I SBIR R43 or 
STTR R41, 2 years;  Phase II SBIR R44 or STTR R42, 3 years; Fast Track 
R41/R42 or R43/R44 application, 4 years.  In any case, the total 
project period may not exceed 4 years, whether submitted as a Fast 
Track or as separate Phase I and Phase II applications.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by eligible, domestic, for-profit small 
business organizations, as described for SBIR and STTR grant 
applications in the Omnibus SBIR/STTR Solicitation.  The parallel 
program announcement, PAR-01-101 (see 
http://grants.nih.gov/grants/guide/pa-files/PAR-01-101.html), has a 
wider range of eligibility that encompasses 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.)  

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.pdf   

Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as principal investigators.

Partnerships with medical device manufacturers to facilitate the 
integration of system components are encouraged, as they enable the 
useful pooling of resources necessary for successful execution of a 
project.  Partnering options available to small business organizations 
may include subcontracts. In addition, joint ventures are eligible 
provided that the entity created qualifies as a small business concern 
as defined in the NIH SBIR/STTR Omnibus Solicitation 
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf).  

INQUIRIES

Inquiries are encouraged.  Opportunities to clarify issues and 
questions from potential applicants are welcome.

Direct inquiries regarding programmatic issues to the following:

For the NCI
Houston Baker, Ph.D. 
Biomedical Imaging Program 
National Cancer Institute 
6130 Executive Plaza, Suite 6000 
Bethesda, MD  20892-7412 
Rockville, MD  20852 (for express/courier service)  
Telephone:  (301) 496 9531 
FAX:  (301) 480 3507 
Email:  bakerhou@mail.nih.gov

For the NIEHS
Jerrold (Jerry) J. Heindel, Ph.D.
Organs and Systems Toxicology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27709
FedEx:  79 T.W. Alexander Drive
4401 Research Commons, 3rd Floor
Telephone:  (919) 541 0781
FAX:  (919) 541 5064
mailto:  heindelj@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

For the NCI
Kathleen J. Shino, M.B.A.
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS 243
Bethesda, MD  20892-7150
Rockville, MD  20852-7150 (for express/courier service)
Telephone:  (301) 846 1016
FAX:  (301) 846 5720
Email:  ks48e@nih.gov 

For the NIEHS
Carolyn B. Winters
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27709
FedEx:  79 T.W. Alexander Drive
4401 Research Commons, 3rd Floor
Telephone:  (919) 541 7823
FAX:  (919) 541 2860
mailto:  winters@niehs.nih.gov

Direct inquiries regarding review matters to:

Ms. Toby Friedberg. 
Referral Officer 
National Cancer Institute 
6116 Executive Boulevard, Room 8109, MSC 8236 
Bethesda, MD  20892-8236 
Rockville, MD  20852 (for overnight/courier service)  
Telephone:  (301) 496 3428 
FAX:  (301) 402 0275 
Email:  tf12W@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a Letter of Intent by the 
date listed at the beginning of this PA and in the SCHEDULE, below.  It 
should provide the number and title of this program announcement, a 
descriptive title of the proposed research, the name, address, 
telephone number, and e-mail address of the Principal Investigator and 
identify other key personnel and participating institutions.  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.  

Address the letter of intent to Dr. Houston Baker at the address listed 
under INQUIRIES, above. 

SCHEDULE

Letter of Intent Receipt:                            June 11, 2001; February 11, 
                                                     2002; June 11, 2002
Application Receipt Date:                            July 16, 2001; March 18, 
                                                     2002; July 16, 2002
Peer Review Date:                                    Oct-Nov, 2001; June-July, 
                                                     2002; Oct-Nov, 2002
Review by National Cancer Advisory Board, or 
  National Environmental Sciences Advisory Council:  February, 2002; September, 
                                                     2002; February, 2003
Earliest Anticipated Start Date:                     March 2002; October, 2002; 
                                                     March 2003

APPLICATION PROCEDURES

SBIR and STTR application information is available at the following 
website:  http://grants.nih.gov/grants/funding/sbir.htm, where 
instructions and application forms in pdf files are hyperlinked as 
Appendices A through E, subtopics under the SBIR/STTR Phase I 
Solicitation link.  

Application forms, requirements and procedures are the same as listed 
in the Omnibus Solicitation for Phase I SBIR/STTR Grant applications 
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf), with the 
following exceptions:  

o  Type the title and number of this PA on line 2 on the face page of 
the application.

o  The Omnibus Solicitation states levels for Phase I and Phase II 
budgets that are guidelines, not ceilings.  Under this PA, the NCI and 
NIEHS will consider larger budgets for longer periods of time that are 
well-justified and necessary to complete the proposed research and 
development.  Phase I budgets are limited to project periods up to a 
two year ceiling, and up to a guideline of $100,000 per year, excluding 
subcontractor facilities and administrative costs.  Include a second 
budget page, and expand the narrative budget justification page(s) to 
provide second year justification if there are significant line item 
differences.  If second year changes reflect only cost of living 
factor(s), include a statement to that effect, the factor(s) used, and 
omit repetition of detail already provided for first year line items.

o  There are no dollar limitations under this PA for Phase II budgets, 
but requested amounts are subject to peer review recommendations, 
availability of funds, and Program priority. 

o  A flexible SBIR/STTR Phase I budget period of one or two years 
(versus the Omnibus Solicitation guideline of 6 months for the SBIR and 
1 year for the STTR).

o  A flexible SBIR/STTR Phase II budget period of one to three years 
(versus the Omnibus Solicitation guideline of up to two years).

o  A four year limit to funding for either a Fast Track, or a Phase I 
and renewal Phase II application.

Specific Aims:  The application must present specific aims that the 
applicant considers technically or scientifically appropriate for the 
relevant phases of the project.  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 R41 or R43 phase of 
feasibility studies, preliminary data are not required, but should be 
included if they are available.  

Project Period and Amount of Award.  Because the length of time and 
cost of research involving advanced technology projects may exceed that 
normally awarded for SBIR/STTR grants, NCI and NIEHS will entertain 
well-justified Phase I applications with a project period up to two 
years and a budget guideline that may not exceed $100,000 per year 
direct and indirect costs (maximum of $200,000 direct and indirect 
costs for up to 2 years, excluding subcontractor facilities and 
administrative costs).  

Phase II Applications.  Phase II applications in response to this PA 
will only be accepted as competing continuations of previously funded 
NIH Phase I SBIR or STTR awards.  The Phase II application must be for 
developmental work that is a logical extension of the Phase I 
feasibility research.  Phase II budgets normally may not exceed 
guidelines of $500,000 total costs per year for the STTR R42 and 
$750,000 total costs per year for the SBIR R44.  Budgets that exceed 
these guidelines require justification.

Applications for Phase II awards should be prepared following the 
instructions for NIH Phase II SBIR or STTR applications.  The Phase II 
SBIR instructions and application may be found on the Internet at: 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

The Phase II STTR instructions and application may be found on the 
Internet at:  http://grants.nih.gov/grants/funding/phs398/phs398.html.

Fast Track Applications.  Applications may be submitted for the Fast 
Track review option.  Information on the Fast Track option may be found 
at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.   

Project Period and Amount of Award.  Because the length of time and 
cost of research may exceed that normally awarded for SBIR grants, NCI 
and NIEHS will entertain well-justified Phase II applications for this 
SBIR/STTR award with project periods up to three years with budget 
levels appropriate for the work proposed (subject to the four year 
funding limit for Phase I and Phase II grants).

Clinical Trials:  All clinical trials supported by any NIH Institute or 
Center require some form of safety monitoring plan.  The method and 
degree of monitoring to be included in the plan should be commensurate 
with the degree of risk involved 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 to a 
Data and Safety Monitoring Board (DSMB).  These monitoring activities 
are distinct from and in addition to the requirement for human subject 
study review and approval by an Institutional Review Board (IRB).  For 
details about the Policy of the NCI for Data Safety Monitoring of 
Clinical Trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  
For additional information, see 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html and 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.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 overnight express or courier 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 8109, MSC 8236 
Bethesda, MD  20892-8236 
Rockville, MD  20852 (for overnight express or courier service) 
Telephone:  (301) 496 3428 
FAX:  (301) 402 0275

The Center for Scientific Review (CSR) will not accept any application 
in response to this PA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application. The CSR will not accept any application that is 
essentially the same as one already reviewed. This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an introduction addressing 
the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCI.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.
Applications that are complete and responsive to the PA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NCI in accordance with the review criteria 
stated below. As part of the initial merit review, all applications 
will receive a written critique and 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, assigned a priority score, and receive a second level review 
by the National 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 the application 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 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 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.
1.  Significance.  Does this study address an important problem? If the 
aims of the application are achieved, how will in vivo imaging 
technology or 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 of 
oncology, environmental health science, or imaging that is not disease 
or organ specific?  Does this project have commercial potential?  What 
may be the anticipated commercial and societal benefits of the proposed 
activity?

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 adequate for the proposed technology, its 
integration as an effective solution for implementation, and 
dissemination? If industrial partnerships are proposed, how will they 
facilitate the development and integration of system components? 

3.   Milestones (for Phase I R41 or R43 or Fast Track applications) and 
Proof of Principle (for Phase II applications).  For the Phase I 
application, how appropriate are the proposed Milestones against which 
to evaluate the demonstration of feasibility for transition to the R42 
or R44 Phase II development work?  Do they provide an objective target 
against which to evaluate results?  For Phase II 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 principal investigator appropriately 
trained, experienced, and well suited to direct or 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 technical and scientific environment in 
which the work will be performed contribute to the probability of 
success?  Does the proposed work take advantage of unique features of 
the technical and scientific environment or employ useful collaborative 
arrangements? 

Additional Considerations:

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

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research. Plans for the recruitment and retention of subjects will also 
be evaluated.

o  The reasonableness of the proposed budget and duration in relation 
to the proposed research.

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may adversely affected by the project 
proposed in the application.

AWARD CRITERIA

Applications recommended by the National Cancer Advisory Board for NCI 
or the National Environmental Sciences Advisory Council for NIEHS will 
be considered for award on the basis of (a) quality of the proposed 
project as determined by peer review; (b) availability of funds; and 
(c) program priority.

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 sub- populations 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 
to indicate 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 updated "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000  
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. 
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

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 which is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may also obtain copies of these policies from program 
staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should 
read the NIH policy on education in the protection of human research 
participants now required for all investigators, which is published in 
the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 
25, 2000), available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A 
continuing education program on the protection of human participants in 
research is now available online at http://cme.nci.nih.gov/.

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 a 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.

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 Technologies for In Vivo Imaging (SBIR/STTR), is 
related to the priority areas of cancer and environmental health. 
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. 93.394, Cancer Detection and Diagnosis Research (NCI), and 93.113. 
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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