INSIGHT AWARDS TO STAMP OUT BREAST CANCER

Release Date:  July 13, 1999

PA NUMBER:  PAR-99-128

National Cancer Institute

Letter of Intent Receipt Date:  September 15, 1999
Application Receipt Date:  October 13, 1999

THIS 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.

PURPOSE

Breast cancer is the most commonly diagnosed cancer of women and the second
leading cause of cancer deaths among women.  In 1998 the National Cancer
Institute (NCI) convened a blue ribbon panel of basic and clinical researchers
from academia, industry, and the government, and representatives of the
patient advocacy community to develop a national plan for the next decade of
breast cancer research.  In addition to identifying specific areas where
breast cancer research should be focused, the Breast Cancer Progress Review
Group (BC-PRG) also recommended that the NCI initiate a program to develop new
and innovative insights in the area of breast cancer research. The purpose of
this program announcement is to directly address these recommendations in the
BC-PRG report by encouraging the submission of applications for new "Insight
Grants" directed against breast cancer.  Both new and established
investigators from a variety of disciplines who want to explore research
topics related to breast cancer in new and innovative ways are encouraged to
apply.

"Insight Grants" are a new initiative designed to support innovative pilot
studies that will generate new understanding of breast cancer.  It is designed
to encourage investigators to explore new research areas where they may not
have previously published or generated preliminary data.  Features of this
initiative include:

o  Support of novel or innovative research that is considered high risk/high
payoff
o  Minimal preliminary data required
o  Maximum of two years with limited budgets
o  Condensed application format with page limitations
o  Review within NCI Division of Extramural Activities by ad hoc review panel
o  Applications are not renewable

The goal of the "Insight Grants" initiative is to generate the needed data to
provide a substantial test of new ideas and to advance underdeveloped areas of
research as identified by the BC-PRG 1998 report
(http://wwwosp.nci.nih.gov/planning/prg/bprgtableofcontents.htm).

HEALTHY PEOPLE 2000

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 Program Announcement (PA), Insight
Awards to Stamp Out Breast Cancer, 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
http://www.crisny.org/health/us/health7.html.

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, 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.

Applications that represent only incremental change in already established
research programs will not be considered.  Applications that propose projects
that are particularly innovative and/or carry a substantial degree of risk but
potentially great reward are especially welcomed.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health
(NIH) exploratory/developmental grant (R21) mechanism.  The R21 grant
mechanism is utilized for pilot projects or feasibility studies to support
creative, novel, high risk/high payoff research that may produce innovative
advances in science.  It is expected that many of the projects supported by
this program will go on to successfully compete for funding through the
traditional funding mechanisms and generate concepts or products that may have
a direct application to public health.  The NCI also recognizes that many of
the projects funded may not mature beyond this program.

Applications submitted in response to this PA will be limited to $75,000 in
direct costs and appropriate facilities and administrative costs per year for
up to two years.  These grants are non-renewable, and continuation of projects
developed under this program will be through the traditional unsolicited
investigator-initiated research grant program.

Applicants will be responsible for the planning, direction, and execution of
the proposed project.  All NIH grants policies will apply to applications
received and awards made in response to this PA.

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://www.nih.gov/grants/funding/modular/modular.htm

FUNDS AVAILABLE

In 1997 Congress passed the "Stamp Out Breast Cancer Act" to help support
breast cancer research and to raise public awareness about the disease.  This
act authorized the sale of breast cancer postage stamps (called semipostals)
by the US Postal Service with a portion of the proceeds to fund breast cancer
research at the National Institutes of Health (NIH).  The program described
herein will be funded through these monies. To date, approximately $4,000,000
is available to support applications submitted in response to this PA.  It is
estimated that with these funds, the NCI will be able to fund 20-25 two-year
awards. Awards pursuant to this PA are contingent upon the receipt of a
sufficient number of applications of outstanding scientific and technical
merit.

RESEARCH OBJECTIVES

Background

Breast Cancer continues to have a devastating impact on the health of women
and men and to impose a large financial burden on the general public.  The
breast is the leading site of new cancer cases in women, and the second
leading cause (after lung cancer) of cancer death among women.  In 1999 alone,
approximately 175,000 women will be diagnosed with invasive breast cancer, and
more than 43,300 will succumb to the disease.  Breast cancer affects women of
all ages, races, ethnicities, socioeconomic strata, and geographical area.

Since its inception, the NCI has supported a variety of basic, clinical, and
population-based research to elucidate the etiology and biology of breast
cancer, and to develop strategies and technologies to aid in the prevention,
detection, and treatment of breast cancer.  This research effort has provided
a wealth of new scientific information that continues to advance all fields in
the fight against breast cancer.

In 1997, the NCI established the Breast Cancer Progress Review Group (BC-PRG)
to analyze the NCI's current breast cancer research portfolio and to develop
recommendations for achieving the next decade of progress.  The panel was
comprised of distinguished basic and clinical researchers from academia,
industry, and government, and representatives of the patient advocacy
community.  The review group presented their findings in a 1998 document
entitled Charting the Course: Priorities for Breast Cancer Research
(http://wwwosp.nci.nih.gov/planning/prg/bprgtableofcontents.htm).  In this
document, they identified and prioritized the scientific needs and
opportunities that need to be addressed to hasten progress against breast
cancer.

The thrust of this initiative as identified in the BC-PRG report is to
establish a broad range program for supporting novel early stage testing of
ideas and concepts in breast cancer research.  This type of research may be
speculative with little preliminary data although founded on sound scientific
rationale.  These grants are intended for both new and established
investigators from all disciplines who want to explore research topics related
to breast cancer in new or innovative ways.  The philosophy behind these high-
risk/ high-payoff grants is that a certain percentage of the concepts put
forth will provide the "seeds" for novel strategies or new areas of research
to be pursued in later stages.  The two-year period of support would allow a
foundation to be established for these special ideas.

Research Goals and Scope

The major goal of this initiative is to provide a special opportunity for the
submission of new and innovative grant applications for breast cancer
research.  These special "Insight Grants" should represent early stages of
investigation and may encompass a new research area for the investigator (See
Eligibility Requirements).  Since this announcement is in direct response to
the BC-PRG, applicants are encouraged to focus their research ideas to areas
identified in the report.  The report can be obtained either via the web at
http://wwwosp.nci.nih.gov/planning/prg/bprgtableofcontents.htm or by mail from
the NCI Office of Science Policy.  The report is comprehensive, covering the
following areas as they relate to breast cancer:

1.  Biology
2.  Etiology
3.  Genetics
4.  Prevention
5.  Detection, Diagnosis, and Prognosis
6.  Treatment
7.  Control
8.  Outcomes

Scientist in all disciplines are invited to participate in this unique
program.  While broad in scope investigators are encouraged to think
creatively and specifically about breast cancer research.

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 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 20, 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://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.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.

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://www.nih.gov/grants/funding/children/children.htm

LETTER OF INTENT

Prospective applicants are asked to submit, by September 15, 1999, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number 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 staff to estimate the potential review workload and avoid conflict of
interest in the review.

The letter of intent is to be sent to the program staff listed under
INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98).  Applications must be received by October 13, 1999.  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, E-mail: [email protected]. The title and
number of the program announcement must be typed in Section 2 on the face page
of the application. The "yes" box must be marked. For those applicants with
internet access, the 398 kit may be found at the following URL address:
http://www.nih.gov/grants/funding/phs398/forms_toc.html

The completed original application and three legible copies must be sent or
delivered 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
Executive Plaza North, Room 636
6130 Executive Blvd., MSC-7399
Rockville, MD 20852 (express courier)
Bethesda MD 20892-7399

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.

SPECIFIC APPLICATION INSTRUCTIONS

BUDGET INSTRUCTIONS

Modular Grant applications  will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS398 application instructions.)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:

PHS 398

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 - Use a Modular Grant Budget Narrative page.
See http://www.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.

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 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.  Indicate whether the collaborating institution
is foreign or domestic. 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.  If large patient care costs or drug acquisition
costs are needed and require additional modules, provide a narrative budget
justification documenting budget costs.

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:
http://www.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  RESOURCES - Provide a description of the clinical and laboratory facilities
in which the study is to be carried out, including data management resources. 
Provide information on resources provided by the drug sponsor if not at your
institution.

o RESEARCH PLAN - Applications in response to this PA should be concise and
substantially shorter than regular grant applications.  ITEMS a-d MUST NOT
EXCEED 10 PAGES IN TOTAL.

Item a - Specific Aims - In one page or less, list in priority order, the
broad, long-range objectives. Describe concisely and realistically the
question and what the specific research described in this application is
intended to accomplish.

Item b - Background and Significance - In two pages or less, use this section
to describe (a) how the proposed research will contribute to meeting the goals
and objectives of the PA; and, (b) explain the rationale for the selection of
the general methods and approaches proposed to accomplish your specific aims.

Items c-d - Progress Report/Preliminary Studies, Research Design and Methods -
In eight pages or less, complete as instructed in the PHS 398 booklet. The
investigator may use this section to address the following:

- Preliminary studies pertinent to the application (if any);

- Rationale for the clinical trial and/or laboratory studies.

- General methods (clinical, laboratory, or both) that will be utilized, as
appropriate; reason(s) for selecting these approaches; provide specific
details for those techniques which are unique or where a significant departure
from a generally accepted technique is important for reviewers to know;

- Outcome measures that will be used to assess the success or failure of each
set of experiments

- Potential pitfalls in the experimental design and alternative studies that
will be done if the proposed experiments fail.

o  CHECKLIST - This page should be completed and submitted with the
application.  If the Facilities and Administrative (F&A) rate agreement has
been established, indicate the type of agreement and the date. It is important
to identify all exclusions that were used in the calculation of the F&A costs
for the initial budget period and all future budget years.

o  APPENDIX - Include a maximum total of 5 publications, manuscripts
(submitted or accepted for publication), abstracts, patents, or other printed
material relevant to this project.  Include letters of collaboration from
collaborators or consultants.

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

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the CSR for completeness and by
the NCI program staff for responsiveness. Incomplete applications will be
returned to the applicant without further consideration. Applications that are
complete and responsive to this PA will be reviewed for scientific and
technical merit by a committee convened by the NCI Division of Extramural
Activities in accordance with the standard NIH peer review procedures.
Following scientific-technical review, the applications will 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. Because of
the unique nature of this program, applications need to be innovative and
address issues in the BC-PRG.  Applications deemed not responsive will be
identified so and not reviewed further.

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?  NOTE: THIS CRITERION
IS CENTRAL TO THE THRUST OF THE PA.

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 as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects; the adequacy
of plans for including children as appropriate for the scientific goals of the
research, or justification for exclusion; the provisions for the protection of
human and animal subjects; and the safety of the research environment.

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 balance.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Dan Gallahan, Ph.D.
Division of Cancer Biology
National Cancer Institute
Executive Plaza North, Room 513
Bethesda, MD 20892
Telephone: (301) 496-7028
FAX: (301) 402-1037
Email: [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Crystal Wolfrey
Grants Management Branch
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD 20892
Telephone: (301) 496-7800
FAX: (301) 496-8601
Email: [email protected]

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Blvd., MSC-7399
Rockville, MD 20852 (express courier)
Bethesda MD 20892-7399
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.399, 93.396, 93.395, and 93.394.  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 PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74 and part 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 and contract 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 of the
American people.

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