Full Text CA-95-016

NATIONAL ACTION PLAN ON BREAST CANCER INNOVATIVE SMALL GRANT PROGRAM

NIH GUIDE, Volume 24, Number 13, April 7, 1995

RFA:  CA-95-016

P.T. 34

Keywords: 
  0715036 
  Biomedical Research, Multidiscipl 


National Cancer Institute

Application Receipt Date:  June 14, 1995

PURPOSE

The National Action Plan on Breast Cancer (NAPBC) is a public-private
partnership created to eliminate the epidemic of breast cancer.  The
Public Health Service's Office on Women's Health, which coordinates
the implementation of the NAPBC, and the National Cancer Institute
(NCI) invite applications for Small Grants (R03) in breast cancer
research and outreach activities to address several priority areas in
the NAPBC.  This program is designed to support the implementation of
six high priority areas for breast cancer that were derived from the
"Proceedings of the Secretary's Conference to Establish a National
Action Plan on Breast Cancer."  These six activity areas are:
information dissemination, national biological resource bank,
consumer involvement, breast cancer etiology, clinical trials
accessibility, and breast cancer susceptibility genes issues.

One goal of this initiative is to provide support for novel, creative
pilot research and outreach projects that, if successful, will yield
exceptionally important new information on breast cancer.  A second
goal is to support developmental, exploratory, or pilot projects that
could serve as the basis for more comprehensive well-defined future
research and outreach project applications in the area of breast
cancer.  Funds to support this Small Grant program will be
administered through the NCI.

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 Request
for Applications (RFA), National Action Plan on Breast Cancer
Innovative 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-
783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic non-profit and for-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State or local governments, and
eligible agencies of the Federal government.  Since this RFA concerns
the National Action Plan on Breast Cancer, foreign or domestic
applications with an international component are not eligible.
Applications from minority and women investigators are encouraged.
Small grant research support may NOT be used to supplement research
projects currently supported by Federal or non-Federal funds.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) small
research grant (R03) as its funding mechanism.  Responsibility for
the planning, direction, and execution of the proposed project will
be solely that of the applicant.  The total project period for an
application submitted in response to the present RFA may not exceed
two years.

Total direct costs up to $50,000 per year are allowed.  The
anticipated award date is September 30, 1995.

Awards and level of support depend on receipt of applications of
sufficient scientific merit.  Although this program is provided for
in the financial plans of the NCI, the award of grants pursuant to
this RFA is contingent upon the continuing availability of funds for
this purpose.

This RFA is a one-time solicitation for new applications.  Future
unsolicited applications will compete with all investigator-initiated
applications and be reviewed according to the customary peer review
procedures.

FUNDS AVAILABLE

Approximately $3,000,000 in total costs per year for two years will
be committed to fund applications submitted in response to this RFA.
It is anticipated that approximately 40 awards will be made.

RESEARCH OBJECTIVES

Background

Breast cancer, the most commonly diagnosed cancer and the second
leading cause of cancer deaths among American women, has been
identified as a public health priority in the United States.  Breast
cancer represents 32 percent of all cancers in women, and the
lifetime risk of developing breast cancer today is one in every eight
women, up from one in every twenty women just two decades ago.

In October 1993, President Clinton was formally presented with a
petition signed by 2.6 million people calling for the establishment
of a comprehensive strategy to end the breast cancer epidemic.  In
response, HHS Secretary Shalala convened the "Secretary's Conference
to Establish a National Action Plan on Breast Cancer" in December
1993.  The conference was a unique undertaking that brought together
for the first time 300 individuals, including advocates, consumers,
clinicians, scientists, government officials, educators, members of
Congress, the media, and others to develop a comprehensive plan for
fighting breast cancer.

The "Proceedings of the Secretary's Conference to Establish a
National Action Plan on Breast Cancer" provides a framework and plan
for activities in three major areas:  the delivery of health care,
the conduct of research, and the enactment of policy.  The document
represents a statement of national opportunities upon which to build
and strengthen knowledge, resources, and commitment in the
prevention, diagnosis, treatment, care and, ultimately, elimination
of breast cancer as a threat to American women.  The Public Health
Service's Office on Women's Health is responsible for the
coordination of the implementation of the NAPBC.  A strong emphasis
of the NAPBC is on the continued creation of public/private
partnerships among consumers, health care professionals, scientists,
private industry, Congress, the media, and Federal and state
government agencies.  In June 1994, the Conference Co-Chairs
Coordinating Group met with government representatives and set six
major priorities for FY 1995 described below.

The NAPBC encourages Small Grant applications (R03) for the conduct
of research or outreach projects related to the following six
priority developmental, exploratory, or pilot areas:  information
dissemination, national biological resource bank, consumer
involvement, breast cancer etiology, clinical trials accessibility,
and breast cancer susceptibility genes issues.

Applicants are encouraged to address the needs of women who may have
been generally underserved in research and outreach activities.

Applicants must address one or more of the six priority areas below.
Within each priority area, examples of issues that may be addressed
include, but are not limited to, the following:

INFORMATION DISSEMINATION:  Develop innovative tools and approaches
for the Information Superhighway to disseminate information to and
facilitate communication between scientists, consumers and
practitioners about breast cancer, breast cancer clinical trials, and
breast health using state-of-the-art information technologies such as
computer systems, interactive videos, CD-ROM, etc.

NATIONAL BIOLOGICAL RESOURCE BANK:  Develop exploratory projects that
would lead to the establishment of biological resource banks to
ensure a national resource of biological materials for several areas
of breast cancer research.  Examples of possible topics include, but
are not limited to, expansion of the number of samples in existing
tissue banks, feasibility studies of the inclusion of other
biological tissues (cell lines, lymphocytes, etc.) in biological
banks, development of new technologies to facilitate the collection
of pertinent background data on samples, and cooperative
participation in the National Biological Resource Bank activities to
increase the availability of samples to investigators across the
country.  In addition, studies to investigate the ethics of using
biological specimens in research are of interest.

CONSUMER INVOLVEMENT:  Ensure consumer involvement at all levels in
the development and implementation of public health and service
delivery programs, research studies, and outreach efforts.  Involve
advocacy groups and women with breast cancer in setting research
priorities and in patient education.

BREAST CANCER ETIOLOGY:  Foster pilot projects to expand the scope of
biomedical, epidemiological, and behavioral research activities
related to the etiology of breast cancer.  Priority areas for pilot
projects include the development and testing of exploratory
procedures, survey instruments, screening tests, etc. that may prove
useful to evaluate:  the effects of radiation and electromagnetic
fields, chemicals, hormones, lifestyle factors, viruses, and gene-
environment interactions.

CLINICAL TRIALS ACCESSIBILITY:  Identify barriers to participation in
clinical trials.  Pilot strategies to overcome presumed barriers
through outreach to consumers and clinicians, through better
understanding of the decision making process for women and their
physicians, through reduction of economic constraints, etc.  Such
pilot projects would lead to the goal of making clinical trials more
widely accessible to women with breast cancer and women who are at
risk for breast cancer.

BREAST CANCER SUSCEPTIBILITY GENES ISSUES:  Address the health needs
and ethical, legal, and policy issues of individuals carrying breast
cancer susceptibility genes.  Recommend and pilot interventions for
consumers, health care providers, and at-risk patient groups which
will lead to the development of a comprehensive plan for these
groups.

Special consideration will be given to the following:

o  Implementing partnerships with private sector groups and/or

o  Including breast cancer consumer/advocacy groups in the design,
conduct and evaluation of clinical/outreach/research strategies and

o  Testing new, innovative designs for ongoing outreach or research
studies.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral 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 new policy results from the NIH
Revitalization Act of 1993 (Section 4928 of Public Law 103-43) and
supersedes and strengthens the previous policies (Concerning the
Inclusion of Women in Study Populations, and Concerning the Inclusion
of Minorities in Study Populations), which have been in effect since
1990.  The new policy contains some provisions that are substantially
different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which was reprinted in the Federal
Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting
errors in the earlier publication, and reprinted in the NIH Guide for
Grants and Contracts, Volume 23, Number 11, March 18, 1994.

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.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for this RFA.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, MD  20892,
telephone 301-435-0714; and from the NAPBC program staff listed under
INQUIRIES.  The RFA label available in the PHS 398 application form
must be affixed to the bottom of the face page.  Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review.  In
addition, the RFA number and title must be typed on line 2a 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 photocopies, in one package
to:

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040 MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for courier/overnight mail service)

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

Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD  20892
Bethesda, MD  20852 (for courier/overnight mail service)

Applications must be received by June 14, 1995.  If an application is
received after that date, it will be returned.  The Division of
Research Grants (DRG) will not accept any application in response to
this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending
application.  The DRG 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.

SPECIAL INSTRUCTIONS FOR THE COMPLETION OF APPLICATION FORM PHS 398

NIH has recently been designated a "re-invention laboratory" by the
Public Health Service.  One component of our efforts to streamline
NIH operations is to simplify the grant application and review
process.

Therefore, an experiment is being conducted to determine ways to
reduce the administrative burden in applying for an NIH grant without
compromising those elements needed by the initial scientific peer
review group to assess the scientific merit of the application and
the reasonableness of the proposed budget.

In responding to the RFA, the following are specific instructions for
sections of the PHS 398 (rev. 9/91) application form that must be
completed DIFFERENTLY from usual.  Some sections are modified and
other sections do not need to be completed for the submission of the
application, but WILL be requested if the application receives a
priority score in the fundable range.  For all other items in the
application, follow the instructions on pages 9-32 of the PHS 398
booklet.

Face Page (Form AA), Item 10, Inventions and Patents - Do not
complete.  See items 3-4, page 8 of these instructions.

Detailed Budget Page for Initial Budget Period (Form DD, page 4) -
Total direct costs may not exceed $50,000 per year.  Enter direct
costs only for the following:

o  Personnel, Patient Care Costs, Alterations-renovations - Complete
these sections as instructed in the PHS 398 booklet.

o  Consultant Costs - Itemize only if proposed consultant costs
exceed $10,000 or if a consultant is identified as key personnel.

o  Equipment - Itemize only individual items in excess of $10,000.

o  Supplies - Itemize (a) all animal costs and (b) any individual
supply item that costs more that $10,000.  If animals are involved,
state their unit purchase and care costs.  Enter total animal costs
and supply costs on separate lines.

o  Travel and Other Expenses - Itemize any individual expense that
exceeds $5,000.

Budget for Entire Proposed Project Period (Form EE, page 5) - Do not
complete this page.  The future year will be automatically escalated
on the direct costs proposed for the first year (minus one time costs
for equipment) by four percent, not to exceed $50,000 direct costs
per year, unless unusual increases of or decreases in future years
are being requested.

Biographical Sketch (Form FF, page 6) - For each KEY person only,
provide no more than a two-page biographical sketch.

o  Name, Position, Title, Education - Complete these sections as
instructed in the PHS 398 booklet.

o  Research and Professional Experience - Identify research
background and experience relevant to the research proposed.
Specifically, provide:

1.  a list of previous research positions that are felt to be of
significance or relevance for the review of the proposed research

2.  complete references, titles, and authors on all peer-reviewed
publications representative of research career or pertinent to the
research proposed

3.  the title and funding source of all active research grants or
contracts on which are principal investigator, co-investigator, or
project leader.  Indicate current percent effort for each award.

4.  the title and length of service on any peer review group,
national advisory council, or program advisory committee

Resources and Environment (Form HH, page 8) - Complete items(s) only
if proposed research requires specialized resources unique for the
proposed research.

C.  Specific Instructions-Research Plan (Booklet, pages 19-24) -
Items 1-4 may not exceed 16 pages in total.

Item 1, Specific Aims - In one page or less, list in priority order,
the broad, long-range objectives.  Describe concisely and
realistically the hypothesis to be tested and what the specific
research described in this application is intended to accomplish.

Item 2, Background and Significance - In five pages or less, use this
section to describe (a) how the proposed research will contribute to
meeting the goals and objectives of the RFA; and (b) explain the
rationale for the selection of the general methods and approaches
proposed to accomplish the specific aims.

Items 3-4 - In ten pages or less, complete as instructed on pages 20-
21 of the PHS booklet with the modification that ONLY five
publications, manuscripts submitted or accepted for publication,
patent, or invention reports can be included in the Appendix (see
page 4).

Members of previous review panels advise that an investigator should
use this section to address the following:

o  preliminary studies pertinent to the application

o  rationale for each particular set of experiments

o  general methods that will be utilized; provide specific details
ONLY for those techniques that are unique or where a significant
departure from a generally accepted technique is important for
reviewers to know

o  outcome measures that will be used to assess the success or
failure of each set of experiments

o  plans for the rigorous management and verification of research
data

o  plans for the early detection of and protection against adverse
effects on human subjects

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

Items 5-6 - Complete as described on pages 22-23.

Item 7, Consultants/Collaborators - Biographical sketches should
conform to the brief format described previously for Form FF.

Item 8, Consortium, Contractual Arrangements - In one page or less,
provide a brief explanation of the programmatic, fiscal and
administrative arrangements made with collaborating organizations.

D.  Specific Instructions-Appendix (Booklet, page 24) - Only five
publications, manuscripts, submitted or accepted for publication,
patents, invention reports should be provided.  Other than this
change, complete as instructed.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by the Division of
Research Grants (DRG) for completeness and by the staff of the NCI
and the Public Health Service's Office on Women's Health working on
the NAPBC for responsiveness.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NAPBC staff may contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group in accordance with the review criteria stated below.  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 will be
discussed and assigned a priority score.

The review group will assess the scientific merit of the studies
using the following review criteria:

o  originality of proposed project;

o  scientific and technical significance of the proposed study;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  research training and qualifications of the Principal Investigator
and staff in the area of the proposed project;

o  availability and quality of the resources necessary to perform the
project;

o  quality of data verification and management plans; and

o  appropriateness of the proposed budget and length of project in
relation to the proposed research.

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

The initial review group will examine the provisions for the
protection of human and animal subjects, the safety of the research
environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.

AWARD CRITERIA

Applications will be considered for award based upon (a) scientific
and technical merit; (b) availability of funds; and (c) programmatic
priorities.  Preference will also be given to investigators who are
new to this research area.

Application Receipt Date:  June 14, 1995
Anticipated Award Date:    September 30, 1995

INQUIRIES

Written and telephone inquiries concerning the objectives and scope
of this RFA and inquiries about whether or not specific proposed
research would be responsive are strongly encouraged.  The program
staff welcome the opportunity to clarify any issues or questions from
potential applicants.

Direct inquiries regarding programmatic issues about the six priority
areas of the NAPBC to:

Susan J. Blumenthal, M.D., M.P.A.
Deputy Assistant Secretary for Health (Women's Health)
Co-Chair, The National Action Plan on Breast Cancer
ATTN:  Suzanne G. Haynes, Ph.D.
Office on Women's Health, USPHS
Hubert Humphrey Building, Room 730-B
200 Independence Avenue, S.W.
Washington, DC  20201
Telephone:  (202) 690-7650
FAX:  (202) 690-7172

Direct inquiries regarding fiscal matters to:

William G. Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
6120 Executive Boulevard
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800, Extension 250
FAX:  (301) 496-8601

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.393, Cancer Cause and Prevention Research; No.
93.394, Cancer Detection and Diagnosis Research; No. 93.395, Cancer
Treatment Research; No. 93.396, Cancer Biology Research; and No.
93.399, Cancer Control.  Awards are made under the authorization of
the Public Health Service Act, Title IV, Part A (Public Law 78-410,
as amended, Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations of 42 CFR Part 52,
45 CFR Part 74, and 45 CFR 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 routing 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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