SMALL GRANTS PROGRAM FOR CANCER EPIDEMIOLOGY

Release Date:  November 28, 2000 (see replacement PAR-03-010)

PA NUMBER:  PA-01-021

National Cancer Institute

Application Receipt Date:  April 20, 2001, August 20, 2001, December 20, 2001, 
                           April 22, 2002, August 20, 2002, December 20, 2002

THIS PROGRAM ANNOUNCEMENT (PA) USES THE MODULAR GRANT AND JUST-IN-TIME 
CONCEPTS.  IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION 
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS 
PA.

This Program Announcement (PA) replaces PAR-98-023 which was published in the 
NIH Guide, Volume 27, Number 7 March 6, 1998. 

PURPOSE

The Division of Cancer Control and Population Sciences of the National Cancer 
Institute (NCI) invites Small Grant (R03) applications relating to cancer 
epidemiology with a primary focus on etiologic cancer research.  These are 
short-term awards intended to provide support for pilot projects, testing of 
new techniques, or development of innovative or high-risk projects that could 
provide a basis for more extended research.

This PA will expire December 21, 2002,  unless reissued.  NIH Grants policies 
apply to these awards.

RESEARCH OBJECTIVES

Investigators may apply for a small grant to support research on a topic 
relevant to cancer etiology, which may lead to cancer control/prevention.  
Investigations may include:

o   Planning a complex epidemiologic investigation,

o   Developing or validating a laboratory or statistical procedure that has 
the potential for improving the quality of cancer epidemiologic research;

o   Obtaining support to study a question relevant to cancer epidemiology in 
special situations, such as the availability of special personnel for limited 
time periods, rapidly evolving research or limited access to an important 
resource;

o   Analyzing previously collected data for epidemiologic purposes, such as 
combining data from several studies to examine consistency or strength of 
observed associations;

o   Resolving methodologic problems, such as documenting the accuracy of a 
customary procedure in preparation for use in epidemiologic research, 
evaluating the effect of cancer diagnosis and/or treatment on risk factor 
estimates derived from case-control studies; or

o   Obtaining funding for investigations of urgent or emergent issues in 
cancer epidemiology.  Applications for support of dissertation research may 
receive a small grant. 

Applications for support of purposes other than those stated will be returned 
to the proposed Principal Investigator without undergoing committee review.

Summary

This initiative permits a wide range of epidemiologic investigations to 
enhance knowledge about the etiology of various cancers and means for their 
prevention. It is intended to encourage:

o   Less experienced investigators;

o   Investigators at institutions without well-developed research traditions 
and resources; or

o   Experienced investigators for exploratory studies which represent a 
significant change in their research direction

MECHANISM OF SUPPORT

Support of this PA will be through the small grants (R03) award mechanism.  
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 applications submitted in response to this announcement may 
not exceed three years.  The NIH has adopted a policy that limits the number 
of amendments to two.  The small grant is not renewable.

Specific application instructions have been modified to reflect “MODULAR 
GRANT” and “JUST-IN-TIME” streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, 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 investigators.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:

Dr. A. R. Patel
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., Room 239C, MSC 7395
Bethesda, MD 20892-7395
Telephone: (301) 496-9600
Fax:  (301) 402-4279
Email: ap39f@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities, 
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf2w@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Sara Stone
Grants Management Branch
National Cancer Institute
6120 Executive Blvd., Suite 243, MSC 7150
Bethesda, MD 20892-7150
Telephone:  (301) 496-9927
Fax:  (301) 496-8601
Email: Stones@gab.nci.gov

APPLICATION PROCEDURES

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.  
Applications 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 301/435-0714, email: 
grantsinfo@nih.gov.  The title and Number of the PA must be typed on line 2 of 
the face page of the application form and the YES box must be marked. For 
those applicants with Internet access, the 398 kit may be found at:
http://grants.nih.gov/grants/forms.htm.

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

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

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,

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 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 http://grants.nih.gov/grants/funding/modular/modular.htm 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 all 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 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 all personnel, 
and the role on the project.  Indicate whether the collaborating institution 
is domestic or foreign.  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 tam.  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:
http://grants.nih.gov/grants/funding/modular/modular.htm.

- 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.

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

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

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

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for Express/courier service)

Applications must be received by the receipt dates listed at the beginning of 
this PA.  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.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the Center for Scientific 
Review and adherence to the guidelines to this PA by the National Cancer 
Institute.  Incomplete applications will be returned to the applicant without 
further consideration.  

Applications that are complete and adhere to the guidelines of this PA will be 
evaluated for scientific and technical merit by an appropriate scientific 
review group convened by the Division of Extramural Activities, 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, 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 
field?

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.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  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. 

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 are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  This  policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing 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 are 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 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.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH solicitation, 
internet addresses (URLs) should not be used to provide information necessary 
to the review because reviewers are under no obligation to view the internet 
sites.  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, Small Grants for Cancer 
Epidemiology, is related to the priority area of cancer and chronic diseases.  
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. 
93.393, Cancer Cause and Prevention Research.  Awards are made under the 
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 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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