Release Date:  December 13, 1999

PA NUMBER:  PAR-00-025

National Cancer Institute

Application Receipt Date:  March 20, July 20, November 20


This  PA replaces  PAR-95-091, which was published in the NIH Guide, Volume 
24, Number 33, September 22, 1995.


The Division of Cancer Prevention of the National Cancer Institute (NCI) 
invites applications that address developmental research in chemoprevention 
agent development, biomarkers, early detection, and nutrition science.  The 
Small Grants Program is designed to aid and facilitate the growth of a 
nationwide cohort of scientists with a high level of research expertise in 
cancer prevention research.  It is anticipated that these Small Grant Programs 
may lead to the submission of subsequent Individual Research Project Grants 

New, as well as experienced, investigators in relevant fields and disciplines 
(e.g., chemoprevention, nutritional science, genetic and infectious agents, 
and early detection, including biomarker development and validation) may apply 
for small grants to test ideas or do pilot studies.

This PA will expire in two years from the first receipt date.  NIH Grants 
policies apply to these awards.


The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2000," a PHS-led national 
activity for setting priority areas. This PA, Cancer Prevention Research Small 
Grant Program, is related to the priority area of Cancer. Potential applicants 
may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 
017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the 
Superintendent of Documents, Government Printing Office, Washington, DC 
20402-9325, telephone 202-512-1800, or at 


Applications may be submitted by domestic, for-profit and not-for-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, eligible agencies of 
Federal government, and small businesses. Racial/ethnic minority individuals, 
women and persons with disabilities are encouraged to apply as principal 


Support of this program announcement will be through NIH Small Grants Program 
(R03). The total budget may not exceed $100,000 in direct costs for the entire 
project. The direct costs in any one year must not exceed $50,000. The total 
project period for an application submitted in response to this program 
announcement may not exceed three years. NIH policy limits the number of 
amendments that may be submitted to two. The small grant is not renewable. 

Specific application instructions have been modified to reflect “MODULAR 
GRANT” and “JUST-IN-TIME” streamlining efforts now in effect at the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 

For this PA, funds must be requested in multiples of  $25,000 direct cost 
modules.  A feature of the modular grant is that no budget escalation is 
provided for future years, and all anticipated expenses for all years of the 
project must be included within the number of modules being requested.  Only 
limited budget information is required and any budget adjustments made by the 
Initial Review Group will be in modules of $25,000.


This program is designed to aid and facilitate the growth of a cadre of 
scientists with expertise in cancer prevention research.  Small grants are 
short-term awards which provide support for pilot projects, development and 
testing of new methodologies, or innovative projects that provide a basis for 
more extended research.

The Division of Cancer Prevention invites applications that address 
developmental research in chemoprevention agent development, biomarkers, early 
detection, and nutrition science, in addition to clinical studies that focus 
on specific target organs. The specific areas of research may include, but are 
not limited to:

Early Detection

Identification, development, and evaluation of biological analytic techniques, 
methodologies, and clinical technologies relevant to pre-clinical cancer 
detection and prevention:
	Cellular, molecular, and genetic tumor markers
	Molecular epidemiology and genetic risk factors
	Imaging technology

Identification of molecular signatures of cancer-associated infectious agents 
for earlier cancer detection and risk assessment.

Transfer of basic laboratory findings into applications for early detection 
with the goal of extending this research to comparative clinical trials.

Development and evaluation of new high throughput molecular- and proteomic-
based detection techniques and measure sensitivity, specificity, validity, and 

Translational research to facilitate the transfer of new technologies (to the 
clinical setting) for earlier detection, prevention, and risk assessment.

Development and evaluation of computer-based data monitoring systems for 
analysis and interpretation of laboratory data on multiple markers of and for 
the development of modeling systems based on molecular, genetic and other risk 
factors to be used in the evaluation of cancer prevention approaches.
Definition and evaluation of prognostic factors of pre-cancerous lesions by 
computer models that include neural networks, artificial intelligence, and 
other techniques.             

Development of analytic techniques to identify populations that may be at 
increased risk as indicated by genetic and metabolic phenotypes 
(susceptibility markers).


Pilot testing and development of new methods of  chemoprevention, dietary, or 
nutrition intervention.

Development and evaluation of molecular targets to prevent, reverse, or retard 
progression of precancerous lesions (and hence the cancer process) by natural, 
synthetic, and/or dietary/nutritional interventions.

Feasibility and efficacy testing of rapid screening methods to identify and 
prioritize new chemopreventive agents.

Testing of new strategies to prevent cancer or its progression in persons at 
increased genetic risk.

Development of innovative animal models to mimic the human cancer process in 
order to expedite research in cancer prevention.


Improvements in methodology development for assessing nutritional status, 
metabolic patterns, and dietary modulation of genetic expression.

Identification, development and validation of biochemical or biological 
markers for measuring and monitoring dietary compliance and exposure.

Development of reliable methods for analysis of nutrients, other dietary 
components and their metabolites in foods, body fluids, and tissues.

Development of mechanistic studies of dietary constituent interactions, gene-
nutrient interactions and dietary environmental factor interactions.

Determination of bioavailability and dose-response of foods, nutrients, and 
other naturally-occurring food constituents. 

Although the specific study proposed may attempt only to obtain preliminary 
data and/or conduct pilot studies in support of a future, more detailed Phase 
III through V study, it is important that a long-term human cancer prevention 
hypothesis and supporting scientific justification be presented. 


This program is designed to increase the basic and applied scientific 
knowledge of cancer prevention research, and enhance community-based clinical 
research in cancer prevention.  


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 
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 on the 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 
Vol. 23, No. 11, March 18, 1994 available on the web at the following URL 


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 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 


The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted 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, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, 
Bethesda, MD 20892-7910, telephone 301/710-0267, email:  
For those applicants with internet access, the 398 kit may be found at:

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES below with any questions regarding the responsiveness of their 
proposed project to the goals of this PA.


Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $50,000 per year. The total direct costs must 
be requested in accordance with the program guidelines and the modifications 
made to the standard PHS 398 application instructions described below:

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities 
and Administrative (F&A) costs] for the initial budget period.  Items 8a and 
8b should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

of the PHS 398.  It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION -  Prepare a Modular Grant Budget Narrative 
page (see for sample 
pages). At the top of the page, enter the total direct costs requested for 
each year.  This is not a form page.

o  Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language 
salary cap if applicable and the NIH policy for graduate student compensation 
in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000. List the individuals/organizations with whom consortium or contractual 
arrangements have been made, the percent effort of key personnel, and the role 
on the project. The total cost for a consortium/contractual arrangement is 
included in the overall requested modular direct cost amount. Include the 
Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at 

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST -  This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate the type 
of agreement and the date. All appropriate exclusions must be applied in the 
calculation of the F&A costs for the initial budget period and all future 
budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

Applications not conforming to these guidelines will be considered 
unresponsive to this PA and will be returned without further review.

In addition, the PA title and number must be typed on line 2 of the face page 
of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, exact, single-sided photocopies, in one package 

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC-7710 
Bethesda, MD 20892-7710 
Bethesda, MD 20817   (for express/courier service) 

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

Ms. Toby Friedberg
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC 8329 
Bethesda MD 20892-8329
Rockville, MD 20852 (for express/courier service)

Applications must be received by March 20, July 20, or November 20.  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.  This does not preclude the submission of 
substantial revisions of applications already reviewed, but such applications 
must include an introduction addressing the previous critique. 


Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the National Cancer Institute.  Incomplete and/or non-
responsive  applications will be returned to the applicant without further 

Applications that are complete and responsive to the program announcement 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 standard NIH peer review procedures.  As part of the 
initial merit review, all applications 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 applications under review, will be 
discussed and assigned a priority score, and 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. 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. 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 scientific knowledge be advanced? What 
will be the effect of these studies on the concepts or methods that drive this 

2. Approach:  Are the conceptual 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 tactics?  

3. Innovation:  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies? 

4. 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)? 

5. 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? 

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, and children as appropriate for the scientific 
goals of the research and 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. 


Applications will compete for available funds with all other approved 
applications assigned to the NCI. The following will be considered in making 
funding decisions: Quality of the proposed project as determined by peer 
review, availability of funds, and program priority. 


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

Direct inquiries regarding programmatic issues to: 
Barry Portnoy, Ph.D.
Division of Cancer Prevention
National Cancer Institute
Building 31, Room 10A49
Bethesda, MD 20892
Telephone: (301) 496-9568
FAX: 301-496-9931

Direct inquiries regarding review issues to: 

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8062, MSC 8329 
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275

Direct inquiries regarding fiscal matters to: 

Bill Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone: (301) 496-8796
FAX: (301) 496-8601


This program is described in the Catalog of Federal Domestic Assistance No. 
93.393.  Cancer Cause and Prevention Research. Awards are made under 
authorization of the 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 Public Health Service (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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