Release Date:  August 16, 1999

PA NUMBER:  PAR-99-141

National Cancer Institute

Letter of Intent Receipt Date:  October 6, 1999
Application Receipt Date:       November 8, 1999


Communication is central to effective, quality cancer care, from primary
prevention to survivorship. The continuing evolution of media technology
offers multiple opportunities to inform health professionals and the public
about cancer information and care in better ways.  This Program Announcement
(PA) is designed to promote and support collaborations between non-profit
organizations and for-profit small businesses on research projects that
address 1) communication with individuals over great distances and in non-
invasive ways about healthy practices known to reduce cancer risks; 2) risk
reduction communication training for health professionals; and/or the 3)
development of organizational infrastructures needed to facilitate rapid
advances in knowledge about cancer communications, testing of intervention
strategies, tailoring models and tools, and dissemination of results.

The National Cancer Institute (NCI) is interested in the development,
implementation, and testing of innovative and commercially viable health
applications using interactive media technologies, television, or radio that
translate cancer research into population specific applications needed by
health care professionals or the public to reduce cancer risks, provide
treatment options, or address the needs of cancer survivors.  Research areas
include innovative alternative teaching methods; healthy life style models,
nutrition interventions, tobacco cessation interventions; tailored
interventions for specific populations including people with disabilities;
educational, training, or tracking systems for primary care professionals or
for the public; telehealth or telemedicine applications; counseling models for
cancer genetics; interventions to enhance cancer-related decision making;
psychosocial interventions for cancer survivors; models to resolve
organizational infrastructure issues; and complementary medicine approaches to

This PA utilizes the R25 and R44 grant mechanisms in tandem to expedite the
transition of successful technology research and development into practical


The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activities for setting priority areas.  This PA, Cancer Communication and
Interactive Media Technology, 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).


For this PA, domestic public or private non-profit organizations such as
universities, colleges, hospitals, foundations, and State and local
governments may apply for the R25.  Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal
Investigators. Prior to submission, the R25 applicant must partner with a for-
profit small business who agrees to prepare the R44 section of the
application. The small business must be independently owned and operated by a
United States citizen or permanent resident alien, whose principal place of
business, including any affiliates, is in the United States.  The business can
not employ more than 500 employees (SBIR OMNIBUS SOLICITATION:

For this PA, the R25 principal investigator must be retained by the small
business as the primary consultant in the R44 phase of the project.  The
Principal Investigator during the R44 phase must come from the small business.


Support for this program announcement is through the NIH Cancer Education and
Career Development Grant (R25), and the Fast Track Small Business Innovation
Research (SBIR) Grant (R44). The R44 Fast Track mechanism is a set-aside
program described in the SBIR OMNIBUS SOLICITATION
(  This is a one-time PA, which
may be reissued.

The R25/R44 is a newly established NIH funding mechanism that provides a
second phase of support for innovative cancer communication and technology
research initiated under the R25 mechanism. Conversion of the R25 to the R44
phase will be based on the successful completion of negotiated milestones that
will result in expediting research into practical commercial applications.

This alternative funding mechanism: 1) allows the R25 principal investigator
to participate in commercialization of the developed end-product; 2) receives
one review for three separate applications, and 3) minimizes the funding gap
between the R25 and the two-phase R44.

Applications for R25 support alone will not be accepted for this PA.  The
R25/R44 application has three sections which must be submitted at the same
time with their own face page: the R25, and Phases I and II of the R44 SBIR
Fast Track, hereafter referred to as the R44.

The total project period for this PA may not exceed four years: R25: 12
months; R44 - Phase I: 6-12 months, Phase II: 2 years.

The one-year R25 and the R44 Phase I may not exceed direct costs (excluding
third party IDC) of $100,000 each. Applicants requesting in excess of $500,000
dollars direct costs in either year of the R44 Phase II must have approval
from NCI Program staff prior to submission. It is strongly recommended that
applicants contact NCI staff at an early stage of application development to
convey critical information, such as potentially large budget requests or to
discuss programmatic responsiveness of the proposed project.  Early contact
with NCI program staff, listed under INQUIRIES, is critical to this PA since
it utilizes a new funding mechanism.

The planning, direction, and execution of the proposed project is the sole
responsibility of the applicant. Awards will be administered under NIH grants
policy as stated in the NIH Grants Policy Statement, NIH Publication No 99-8,
October 1998.


Effective communication and its impact on health have been the focus of
scientists and communicators for more than 25 years.  In 1971, the National
Cancer Act charged NCI with the dissemination and interpretation of scientific
and other information regarding the causes, prevention, detection and
treatment of cancer for practitioners, other health professionals, scientists,
and the general public. Within the past decade, NCI has utilized a wide array
of technologies to expand cancer communications to ensure that all Americans
have access to the cancer information they need. As a result of these efforts,
it has become apparent that there is a need to increase the demand for and
expand the use of these technologies by the public, patients, high-risk
persons, advocates, survivors and health professionals regardless of race,
ethnicity, health status, education, income, age, gender, or geographic

There is evidence that communication technologies are altering health care
practices, patient-physician relationships and the way consumers and patients
acquire and use information.  Effective health communications have influenced
American adults to increase their daily consumption of fruits and vegetables,
to get screened for breast and cervical cancers, and to stop or limit their
use of tobacco products.  Today's technology users are often as informed or
more informed than their physicians because of new opportunities for acquiring
health information from the World Wide Web, individually-tailored print,
multimedia products such as cancer-specific CD-ROMs, interactive computer
games, interactive kiosks, and wireless pagers, among others.

The current communications revolution offers better ways to train health care
professionals on how to utilize technology to reach people with cancer
information, and simultaneously improve health outcomes, decrease health care
cost, and enhance consumer satisfaction.  However, before we can train health
professional to effectively communicate about cancer or develop effective
interactive health communication products and interventions, we need to learn
how people seek, process and use health information.

Proactive communication strategies are needed across the cancer continuum to
rapidly accelerate a reduction in the cancer burden and across the life span. 
In order to be successful, these strategies would have to cover a broad cross-
section of the U.S. population to reach the most vulnerable population groups. 
Communications research is also needed among diverse population groups on how
to increase their demand for access to cancer information (children, ethnic
minorities, recent immigrants, low income groups, low literacy groups, rural
populations, older adults and people at high-risk because of previous
diseases, behaviors, exposures, genetic susceptibility or some other factor,
patients, survivors, and health providers.)

Cancer communications research should be science-based, developed in
collaboration with consumers, industry and academia, and result in high-
quality products that have been evaluated for utilization, efficacy and impact
on the target audiences.  Anticipated results should include, but are not
limited to, mechanisms for removing cost barriers; tools to increase
familiarity, ease of use, appeal and vividness; culturally appropriate
interventions; comprehensive and relevant messages; a flexible and adaptable
menu of communication choices to reach the public, patients, underserved
populations, survivors, and health providers in a variety of settings; and
developed infrastructures, in health care and community settings, needed to
facilitate rapid advances in knowledge about cancer communications, testing of
strategies, models and tools, dissemination of results to researchers,
clinicians, patients, practitioners, advocacy groups and other partners and
the public.

Objectives and Scope

Interested applicants are encouraged to develop systems, interventions,
programs and/or products that: 1) improve transmission of cancer information;
2) promote cancer-related behavior change; 3) reduce cancer risk among youth
and adults; 4) improve health outcomes and quality of life; 5) improve
decision making and adherence to cancer prevention, detection and treatment;
and 6) improve survivorship.  Research in any of the following areas is
considered to be appropriate.  These illustrative examples are not all
inclusive.  Applicants could address one or a combination of these needs. 
Technology tools to facilitate these types of research include, but are not
limited to, computer software, expert systems, tracking databases, advanced
telephone technologies, videotext, cable or broadcast television, radio,
virtual reality, animation, imaging, and the World Wide Web.

For any of the following, it is important for applicants to indicate the
ultimate value of their research and how it will increase the knowledge about
cancer communications.


--- Develop evidence-based strategies for involving the public, children and
people from vulnerable, high-risk populations in programs to prevent or stop
tobacco use; improve dietary practices and increase physical activity;
participate in cancer screening or treatment, prolong survivorship, and other
areas noted above.

--- Develop new tools, products, and methods to enhance information
dissemination and strategies to improve the penetration, efficacy,
effectiveness and dissemination of cancer communications based on how people
search for and use cancer information.  Develop optimal formats for
communicating cancer risks to culturally sensitive to diverse audiences.

--- Develop guidelines for users to determine the quality of health
information on the Web or viewed through other interactive health
communication technologies.

--- Develop strategies for teaching people how to separate important from
insignificant risks and deal with contradictory health messages so that they
can make informed choices.

--- Develop practical decision aids to improve patient-provider communication
and to help people make better cancer-related decisions.

--- Develop health communication technology tools to assist physicians in
maximizing their communication about cancer and integrating cancer
communications into all aspects of cancer care.

--- Develop practical tailored strategies to enhance cancer communications and
address barriers that prevent major segments of the population from seeking
and/or using cancer information.

--- Develop products that present balanced information about complementary
cancer therapies.


--- Develop systems or models for using interactive health communication
technologies in organizational infrastructures (hospitals, clinics, HMOs,
schools, worksites) that resolve barriers to use.

--- Develop long-term cancer communication tracking systems that monitor
outcome measures.

--- Develop integrated systems of cancer information from prevention through
treatment to survivorship and to end-of-life issues including palliative care
and pain management that is consistent with 1999 recommendations from the
Institute of Medicine ( (under other

--- Develop integration systems of cancer care and best practices information
on how to communicate uncertainty about risks, and reduce disparities in
demand for, access to, and use of cancer communications.

--- Develop information systems for the public or health care providers that
give people the information they want, how they want it, when and where they
want it.


--- Develop training modules for instructors to teach medical, nursing, and
public health students to translate cancer research findings into population
specific applications using a variety of multimedia technology.

--- Develop training modules for persons who cover scientific or medical
meetings and present the information in writing or through different forms of
media technology.


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
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." These guidelines have been published in the Federal Register (March
20, 1994 (FR 59 14508-14513), in the NIH Guide for Grants and Contracts,
Volume 23, Number 11, March 18, 1994, and are available at:


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".  A copy of the Policy can be found in the
NIH Guide for Grants and Contracts, March 6, 1998, or at:


Prospective applicants are asked to submit, by the date listed in the heading
of this program announcement, a letter of intent that includes a descriptive
title of the proposed research, the name, address, telephone number and Email
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 Connie Dresser, at the address listed under


R25/R44 Contents

The R25/R44 is submitted as one application and consists of three sections,
each with its own face page: 1) the R25 (form PHS 398); 2) the R44 Phase I
(PHS 6246-1); and 3) the R44 Phase II (PHS 6246-2).  R25/R44 applications must
be post marked by November 8, 1999.  The PA title and number must be typed on
line 2 of all three face pages.

The R25/R44 application will be assigned a single priority score. As discussed
in the REVIEW CONSIDERATIONS section, the initial review panel has the option
of scoring only the R25 or only the R25 and the R44 Phase I.  An unscored R44
Phase II will reflect upon the judgement of the applicant.  For these reasons,
clear and complete goals and feasibility milestones for each section of the
R25/R44 application are critical.

R25 Application and Preparation

The R25 is to be submitted on form PHS 398 (rev. 4/98) and prepared according
to the instructions provided unless specified otherwise within this section.
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: Applications are also available on the web at:

The R25 should state the overall justification and objectives of the entire
R25/R44 project and how and who will conduct the research. The R25 part of the
application includes content development and focus group review that must be
completed prior to the beginning of the R44 Phase I.  For example, if a
training module is proposed, the entire content of the training module is
developed "on paper" and focus groups of experts and end-users are convened to
critique and assist with the refinement of the final "paper" product that is
to be developed, implemented, and evaluated in R44 Phases I and II.

The R25 must include a "Milestones" section, following the Research Plan, that
describes the research aims and measures of feasibility that justify
transition to the R44 Phase I.  The milestones must be quantifiable and
scientifically justified and relevant to R25 progress and the successful
completion of the R44 Phase I.  Applications lacking this information, as
determined by the NCI program staff, will be returned to the applicant without

In the R25 budget justification section, a timeline and a dollar level for all
three phases (R25, R44 Phase I, R44 Phase II) must be included. This should be
in chart format and include direct as well as total costs for all three phases
separately and as an aggregate.  The release of funds for the R44 Phases I and
II will be based on topics discussed in the REVIEW CONSIDERATIONS section.

R44 Application and Preparation

The R44 section consists of Phases I and II of the SBIR Fast Track. 
Electronic application forms for R44 Phase I - PHS 6246-1 (1/98) and R44 Phase
II - PHS 6246-2 (1/98) are available at:

General instructions for their preparation can be found in the electronic
version of the SBIR OMNIBUS SOLICITATION at the "Small Business Funding
Opportunities" website:
Detailed information is available at:

Applications for R44 Phases I and II (PHS 99-2) and instructions for their
preparation in hard copy may be obtained from the PHS SBIR/STTR Solicitation
Office, Phone: (301) 206-9385; Fax: (301) 206-9722; email

As described in OMNIBUS SOLICITATION, both R44 Phases I and II must be
completed, each with its own face page.  All of the instructions within the
OMNIBUS SOLICITATION apply with the following exceptions:

-Special receipt date
-Initial review convened by the NCI Division of Extramural Activities
-Additional review considerations.
-More flexible time and budget specifications
-Inclusion of a Product Development Plan Appendix in the R44 Phase I

Both Phases of the R44 must include specific aims and the feasibility
milestones that would justify transition from the R44 Phase I to the Phase II. 
The Phase I must include a specific section labeled "Milestones," followed by
a Research Plan. Milestones should be well described, quantifiable,
scientifically justified and relevant to the progress of the Phase I and the
successful completion of the Phase II.  Applications lacking this information,
as determined by the NCI program staff, will be returned to the applicant
without review.

In the R44 Phase I, the applicant is responsible for testing the feasibility
of translating the "paper" product, developed in the R25, to a form of media
technology with a group of experts and end-users. In the R44 Phase II, the
applicant is expected to develop the technology transfer medium, and implement
and test the efficacy and effectiveness of the product with specific
populations. A detailed product development plan and a business plan for
distribution must be included.  Program highly recommends that all applicants
locate potential backers for the commercialization of the final product prior
to submitting the R25/R44.

Release of R44 Phase I funds is contingent upon the successful completion of
the milestones described in the R25.  Likewise, release of R44 Phase II funds
are contingent upon the successful completion of the milestones described in
the R44 Phase I.

If an application is received after the application receipt 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 has been
submitted as a traditional SBIR, unless the applicant withdraws the pending
SBIR application.

The R25/R44 application (R25, R44 Phase I and R44 Phase II in one package) and
three legible copies of the entire application package must be sent or
delivered to:

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 package
must be sent to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda, MD 20892-7399
Rockville, MD 20852 (for express/courier service)


Upon receipt, the R25/R44 application will be reviewed by the CSR for
completeness and by the NCI for responsiveness.  Applications not adhering to
application instructions described above and those applications that are
incomplete or non-responsive will be returned to the applicant without review.

Applications will be reviewed for scientific and technical merit and the
documented ability of the investigators to meet the RESEARCH OBJECTIVES of
this PA by an initial review group convened by the NCI Division of Extramural
Activities, in accordance with the standard NIH peer review procedures.  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 Cancer Advisory Board. Reviewers reserve the
right to score the entire R25/R44 application, only the R25, or the R25 and
the R44 Phase I.

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.

The reviewers will evaluate each of the three sections as described below
(R25, R44 Phase I, R44 Phase II). Following this evaluation and the evaluation
of issues included under "Additional Considerations," a single score will be
assigned to the R25/R44.


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 be on the concepts or methods that drive
this field? To what degree does the technology support the needs of the
targeted research community?

2. Approach.  Are the conceptual frameworks, 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? Is the time frame appropriate for completing the
description of the content, design, and operation of the proposed health
communication application? How easy will it be to use the proposed health
communication application?

3. Milestones. How appropriate are the proposed milestones against which to
evaluate the demonstration of feasibility for transition to the R44 phases?

4. Innovation.  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?

5. 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)?

6. Environment.  Does the scientific environment in which the work will be
done contribute to the probability of success? Is there evidence of
institutional support?

R44 Phases I and II

The following criteria, described in the OMNIBUS SOLICITATIONS, are emphasized
for this PA:

1.  The soundness and technical merit of the proposed approach.
2.  The qualifications of the proposed principal investigator, supporting
staff, and consultants.
3.  The scientific and technological innovation of the proposed research.
4.  The potential of the proposed research for commercial application.
5.  The appropriateness of the budget requested.
6.  The adequacy and suitability of the facilities and research environment.
7.  Adequate assurances detailing the proposed means for safeguarding human
8.  Innovative aspects of the approaches used in delivering cancer

The R25 and the R44 Phase I must specify clear, measurable goals (milestones)
that should be achieved prior to initiating the R44 Phase II.  A MILESTONES
section must be included in both the R25 and the R44 Phase I.  Failure to
provide clear, measurable goals may be sufficient reason for the initial
review group to judge the application non-competitive.

Additional Considerations

For the overall application, the initial review group will evaluate the
specific goals for each of the three sections of the R25/R44 and the
feasibility milestones that would justify expansion from the R25 to the R44. A
single priority score will be assigned to the overall application if it
receives a priority score.  As with any grant application, the initial review
group has the option of recommending support for a shorter duration than that
requested by the applicant. This may result in a recommendation that only the
R25 or the R25 and R44 Phase I be supported, based on concerns related to the
applicant's specific goals and the feasibility milestones justifying expansion
to the subsequent phases. Non-meritorious content may result in the deletion
of any section of the R25/R44 by the review panel and will affect the merit
rating of the application.

The initial review group will also examine: the appropriateness of the
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 provisions for the protection of human subjects; and the safety of the
research environment as well as the adequacy of plans for including children
as appropriate for the scientific goals of the research, or justification for


Funding decisions for the R25 and R44 Phases I and II will be based on quality
of the proposed project as determined by peer review, program priority,
potential for clinical success, and availability of funds.


Letter of Intent Receipt Date:          October 6, 1999
Application Receipt Date:               November 8, 1999
National Cancer Advisory Board Review:  May 2000
Earliest Anticipated Award Date:        July 2000


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

Direct inquiries regarding programmatic issues to:

Connie Dresser, RDPH, LN
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 232
Bethesda, MD  20892-7330
Telephone:  (301) 496-8520
FAX:  (301) 480-6637

Direct inquiries regarding fiscal matters to:

Ms. Kathleen Shino
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20892-7150
Telephone: (301)  496-8635
FAX: 301/496-8601

Direct inquiries regarding review matters to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC 7399
Bethesda MD, 20892-7399
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496 -3428
FAX: (301) 402-0275


This program is described in the Catalog of Federal Domestic Assistance No.
93.399.  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 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 health of
the American people.

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